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Clinical development challenges faced by advanced therapies for rare disease | Blog | ICON plc
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Since the first gene therapy for a rare paediatric leukaemia was approved by the U.S. Food and Drug Administration (FDA) in <a href="https://www.fda.gov/news-events/press-announcements/fda-approval-brings-first-gene-therapy-united-states" target="_blank">2017</a>, there has been mounting excitement that advanced therapies could help manage, or even provide a durable solution for, rare diseases. These ‘living’ therapies are designed to have long-lasting or permanent effects that restore biological function and address the underlying cause of disease. This includes genetic causes, which account for the majority of rare diseases.</p><p>The excitement around advanced therapies for rare disease has been amplified by the overwhelming, unmet need for treatment options. At present, 90 percent of rare diseases have no FDA-approved therapies. While there is a great need for rare disease advanced therapies, clinical development and subsequent market authorisation remains challenging. This blog discusses common hurdles and considerations for the clinical development of rare disease advanced therapies.</p><p><strong>Rare disease clinical development</strong></p><p>The primary challenges of rare disease clinical development, regardless of therapeutic class, include a limited patient population, wide geographic distribution of these patients and minimal preclinical data. Rare diseases are often poorly characterised, and have only a few specialists with the expertise to run a clinical trial. In addition, clinical trials must recruit from an extremely small population, and this population is often paediatric patients with life threatening conditions. The limited number of participants, paired with an ethical obligation to treat as many as possible, means that controls are designed to be very small or external to the trial. Great unmet need also means that rare diseases are often eligible for expedited market authorisation. Most commonly, the development pipeline for a rare disease involves a phase 1/2 combined trial, a phase 3 trial and market approval followed by patient follow-up and phase 4 trials.</p><p><strong>Advanced therapy clinical development</strong></p><p>Development challenges specific to advanced therapy clinical development include stringent regulations during manufacturing and production, and limited preclinical information to guide clinical trial design. Establishing manufacturing and quality standards is also a major challenge for advanced therapies, because their biological nature can pose unique risks, including immunogenicity and variable efficacy. In addition, animal models are unsuitable for preclinical studies, limiting preclinical data before first-in-human trials. Many advanced therapies also should not be tested on healthy volunteers, limiting first-in-human studies to the target population.</p><p>Advanced therapies specifically for rare diseases must navigate the compounding challenges faced in rare disease and advanced therapy development. A strategic regulatory strategy will help ensure that these therapies get the appropriate resources during development and consideration during market authorisation.</p><p>For more information on unlocking the potential of advanced therapies developed for rare diseases, read our <a href="https://www.iconplc.com/insights/therapeutics/rare-and-orphan-diseases/advanced-therapies-for-rare-diseases" target="_self">whitepaper </a>and check out our regulatory strategy <a href="/insights/blog/2022/09/19/advanced-therapies-for-rare-disease-a-regulatory-roadmap/" target="_self">blog</a>.</p></div> </div> </div> </div> </div> </div> </div> </div> </div><div id="8361cee3-4841-4a6c-97db-d8eb07cc2b37"> <div class="group group--with-carousel bg-white content-visibility--auto contain-intrinsic-size--400 related-content-carousel"> <div class="container-fluid container-fluid--xl"> <h2 class="group__title"> Related Information </h2> <div class="carousel--standard carousel--standard-1-3-4"> <a 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menu-level-2"> <li> <a href="/insights/digital-disruption/ai-and-clinical-trials/impact-of-ai-on-outcomes-based-contracting" data-drupal-link-system-path="node/33605">Impact of AI on Outcomes Based Contracting</a> <div class="collapse " id="ai-and-clinical-trials-impact-of-ai-on-outcomes-based-contracting-10592" > </div> </li> <li> <a href="/insights/digital-disruption/ai-and-clinical-trials/using-ai-for-site-id-and-selection" data-drupal-link-system-path="node/33607">Using AI for site ID and selection</a> <div class="collapse " id="ai-and-clinical-trials--using-ai-for-site-id-and-selection-10593" > </div> </li> <li> <a href="/insights/digital-disruption/ai-and-clinical-trials/applying-ai-manage-risks-and-costs-postmarketing" data-drupal-link-system-path="node/40261">Applying AI to manage the risks and costs of postmarketing requirements</a> <div class="collapse " id="ai-and-clinical-trials---applying-ai-to-manage-the-risks-and-costs-of-postmarketing-requirements-11291" > </div> </li> </ul> </div> </li> <li> <a href="/insights/digital-disruption/anonymisation-of-sdtm-for-data-sharing" data-drupal-link-system-path="node/33608">Clinical trial data anonymisation and data sharing</a> <div class="collapse " id="digital-disruption----clinical-trial-data-anonymisation-and-data-sharing-10594" > </div> </li> <li> <a href="/insights/digital-disruption/ai-icon" data-drupal-link-system-path="node/41646">AI at ICON</a> <div class="collapse " id="digital-disruption-----ai-at-icon-11651" > </div> </li> <li> <a href="/insights/digital-disruption/clinical-trial-tokenisation" data-drupal-link-system-path="node/33609">Clinical Trial Tokenisation</a> <div class="collapse " id="digital-disruption------clinical-trial-tokenisation-10595" > </div> </li> <li> <a href="/insights/digital-disruption/closing-the-evidence-gap-the-value-of-digital-health-technologies-in-supporting-drug-reimburement-decisions" data-drupal-link-system-path="node/33610">Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions</a> <div class="collapse " id="digital-disruption-------closing-the-evidence-gap-the-value-of-digital-health-technologies-in-supporting-drug-reimbursement-decisions-10596" > </div> </li> <li> <a href="/insights/digital-disruption/digital-disruption-in-biopharma" data-drupal-link-system-path="node/33611">Digital disruption in biopharma</a> <div class="collapse " id="digital-disruption--------digital-disruption-in-biopharma-10597" > </div> </li> <li> <a href="/insights/digital-disruption/disruptive-innovation" data-drupal-link-system-path="node/33612">Disruptive Innovation</a> <div class="collapse " id="digital-disruption---------disruptive-innovation-10598" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#digital-disruption----------remote-patient-monitoring-10599"></span> <a href="/insights/digital-disruption/mHealth-wearables" data-drupal-link-system-path="node/33618">Remote Patient Monitoring</a> <div class="collapse " id="digital-disruption----------remote-patient-monitoring-10599" > <ul class="menu menu-level-2"> <li> <a href="/insights/digital-disruption/remote-patient-monitoring/bring-your-own-device" data-drupal-link-system-path="node/33614">Bring Your Own Device</a> <div class="collapse " id="remote-patient-monitoring-bring-your-own-device-10600" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#remote-patient-monitoring--cybersecurity-10601"></span> <a href="/insights/digital-disruption/remote-patient-monitoring/cybersecurity" data-drupal-link-system-path="node/33616">Cybersecurity</a> <div class="collapse " id="remote-patient-monitoring--cybersecurity-10601" > <ul class="menu menu-level-3"> <li> <a href="/insights/digital-disruption/mHealth-wearables/cybersecurity/cybersecurity-checklist" data-drupal-link-system-path="node/33615">Addressing cybersecurity for your medical device</a> <div class="collapse " id="cybersecurity-addressing-cybersecurity-for-your-medical-device-10602" > </div> </li> </ul> </div> </li> <li> <a href="/insights/digital-disruption/mHealth-wearables/digital-endpoints" data-drupal-link-system-path="node/33617">Digital Endpoints</a> <div class="collapse " id="remote-patient-monitoring---digital-endpoints-10603" > </div> </li> <li> <a href="/insights/digital-disruption/remote-patient-monitoring/transforming-medical-device-development" data-drupal-link-system-path="node/33619">Transforming Medical Device Development with mHealth</a> <div class="collapse " id="remote-patient-monitoring----transforming-medical-device-development-with-mhealth-10604" > </div> </li> </ul> </div> </li> <li> <a href="/insights/digital-disruption/personalising-digital-health" data-drupal-link-system-path="node/33620">Personalising Digital Health</a> <div class="collapse " id="digital-disruption-----------personalising-digital-health-10605" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#digital-disruption------------real-world-data-10606"></span> <a href="/insights/digital-disruption/real-world-data" data-drupal-link-system-path="node/33621">Real World Data</a> <div class="collapse " id="digital-disruption------------real-world-data-10606" > <ul class="menu menu-level-2"> <li> <a href="/insights/digital-disruption/real-world-data/maximise-rwe-value" data-drupal-link-system-path="node/33622">Harnessing technology to maximise Real World Evidence value</a> <div class="collapse " id="real-world-data-harnessing-technology-to-maximise-real-world-evidence-value-10607" > </div> </li> <li> <a href="/insights/digital-disruption/real-world-data/meeting-evidentiary-needs" data-drupal-link-system-path="node/33623">Meeting Evidentiary Needs with EHRs</a> <div class="collapse " id="real-world-data--meeting-evidentiary-needs-with-ehrs-10608" > </div> </li> <li> <a href="/insights/digital-disruption/real-world-data/post-market-surveillance" data-drupal-link-system-path="node/33624">Post-Market Surveillance for Medical Devices</a> <div class="collapse " id="real-world-data---post-market-surveillance-for-medical-devices-10609" > </div> </li> </ul> </div> </li> <li> <a href="/insights/digital-disruption/triad-trust-navigating-real-world-healthcare-data-integration" data-drupal-link-system-path="node/40066">The triad of trust: Navigating real-world healthcare data integration</a> <div class="collapse " id="digital-disruption-------------the-triad-of-trust-navigating-real-world-healthcare-data-integration-11271" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#patient-centricity-10610"></span> <a href="/insights/patient-centricity" data-drupal-link-system-path="node/33633">Patient Centricity</a> <div class="collapse " id="patient-centricity-10610" > <ul class="menu menu-level-1"> <li> <a href="/insights/patient-centricity/agile-clinical-monitoring" data-drupal-link-system-path="node/33626">Agile Clinical Monitoring</a> <div class="collapse " id="patient-centricity-agile-clinical-monitoring-10611" > </div> </li> <li> <a href="/insights/patient-centricity/capturing-the-voice-of-the-patient-in-clinical-trials" data-drupal-link-system-path="node/33627">Capturing the voice of the patient in clinical trials</a> <div class="collapse " id="patient-centricity--capturing-the-voice-of-the-patient-in-clinical-trials-10612" > </div> </li> <li> <a href="/insights/patient-centricity/charting-the-managed-access-program" data-drupal-link-system-path="node/33628">Charting the Managed Access Program Landscape</a> <div class="collapse " id="patient-centricity---charting-the-managed-access-program-landscape-10613" > </div> </li> <li> <a href="/insights/patient-centricity/developing-nurse-centric-medical-communications" data-drupal-link-system-path="node/33629">Developing Nurse-Centric Medical Communications</a> <div class="collapse " id="patient-centricity----developing-nurse-centric-medical-communications-10614" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#patient-centricity-----diversity-and-inclusion-in-clinical-trials-10615"></span> <a href="/insights/patient-centricity/diversity-and-inclusion-clinical-trials" data-drupal-link-system-path="node/33631">Diversity and inclusion in clinical trials</a> <div class="collapse " id="patient-centricity-----diversity-and-inclusion-in-clinical-trials-10615" > <ul class="menu menu-level-2"> <li> <a href="/insights/patient-centricity/diversity-and-inclusion-in-clinical-trials/diversity-and-inclusion-in-clinical-trials-whitepaper" data-drupal-link-system-path="node/33630">Diversity and inclusion in clinical trials whitepaper</a> <div class="collapse " id="diversity-and-inclusion-in-clinical-trials-diversity-and-inclusion-in-clinical-trials-whitepaper-10616" > </div> </li> </ul> </div> </li> <li> <a href="/insights/patient-centricity/exploring-the-patient-perspective-from-different-angles" data-drupal-link-system-path="node/33632">Exploring the patient perspective from different angles</a> <div class="collapse " id="patient-centricity------exploring-the-patient-perspective-from-different-angles-10617" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#patient-centricity-------patient-safety-and-pharmacovigilance-10618"></span> <a href="/insights/patient-centricity/patient-safety-and-pharmacovigilance" data-drupal-link-system-path="node/33635">Patient safety and pharmacovigilance</a> <div class="collapse " id="patient-centricity-------patient-safety-and-pharmacovigilance-10618" > <ul class="menu menu-level-2"> <li> <a href="/insights/patient-centricity/patient-safety-and-pharmacovigilance/a-guide-to-safety-data-migrations" data-drupal-link-system-path="node/33634">A guide to safety data migrations</a> <div class="collapse " id="patient-safety-and-pharmacovigilance-a-guide-to-safety-data-migrations-10619" > </div> </li> <li> <a href="/insights/patient-centricity/patient-safety-and-pharmacovigilance/taking-safety-reporting-next-level" data-drupal-link-system-path="node/33636">Taking safety reporting to the next level with automation</a> <div class="collapse " id="patient-safety-and-pharmacovigilance--taking-safety-reporting-to-the-next-level-with-automation-10620" > </div> </li> <li> <a href="/insights/patient-centricity/patient-safety-and-pharmacovigilance/outsourced-pharmacovigilance" data-drupal-link-system-path="node/33637">Outsourced Pharmacovigilance Affiliate Solution</a> <div class="collapse " id="patient-safety-and-pharmacovigilance---outsourced-pharmacovigilance-affiliate-solution-10621" > </div> </li> <li> <a href="/insights/patient-centricity/patient-safety-and-pharmacovigilance/evolution-pharmacovigilance-system" data-drupal-link-system-path="node/33638">The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities</a> <div class="collapse " id="patient-safety-and-pharmacovigilance----the-evolution-of-the-pharmacovigilance-system-master-file-benefits-challenges-and-opportunities-10622" > </div> </li> <li> <a href="/insights/patient-centricity/patient-safety-and-pharmacovigilance/sponsor-and-cro-pharmacovigilance-and-safety-alliances" data-drupal-link-system-path="node/33639">Sponsor and CRO pharmacovigilance and safety alliances</a> <div class="collapse " id="patient-safety-and-pharmacovigilance-----sponsor-and-cro-pharmacovigilance-and-safety-alliances-10623" > </div> </li> <li> <a href="/insights/patient-centricity/patient-safety-and-pharmacovigilance/understanding-the-periodic-benefit-risk-evaluation-report" data-drupal-link-system-path="node/33640">Understanding the Periodic Benefit-Risk Evaluation Report</a> <div class="collapse " id="patient-safety-and-pharmacovigilance------understanding-the-periodic-benefit-risk-evaluation-report-10624" > </div> </li> </ul> </div> </li> <li> <a href="/insights/patient-centricity/patient-voice-survey" data-drupal-link-system-path="node/33642">Patient voice survey</a> <div class="collapse " id="patient-centricity--------patient-voice-survey-10625" > </div> </li> <li> <a href="/insights/patient-centricity/patient-voice-survey-decentralised-and-hybrid-trials" data-drupal-link-system-path="node/33641">Patient Voice Survey - Decentralised and Hybrid Trials</a> <div class="collapse " id="patient-centricity---------patient-voice-survey-decentralised-and-hybrid-trials-10626" > </div> </li> <li> <a href="/insights/patient-centricity/reimagining-patient-centricity-with-the-iomt" data-drupal-link-system-path="node/33643">Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)</a> <div class="collapse " id="patient-centricity----------reimagining-patient-centricity-with-the-internet-of-medical-things-iomt--10627" > </div> </li> <li> <a href="/insights/patient-centricity/using-longitudinal-qualitative-research-to-capture-the-patient-voice" data-drupal-link-system-path="node/33644">Using longitudinal qualitative research to capture the patient voice</a> <div class="collapse " id="patient-centricity-----------using-longitudinal-qualitative-research-to-capture-the-patient-voice-10628" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#regulatory-intelligence-10629"></span> <a href="/insights/regulatory-intelligence" data-drupal-link-system-path="node/33659">Regulatory Intelligence</a> <div class="collapse " id="regulatory-intelligence-10629" > <ul class="menu menu-level-1"> <li> <a href="/insights/regulatory/an-innovative-approach-to-rare-disease-clinical-development" data-drupal-link-system-path="node/33646">An innovative approach to rare disease clinical development</a> <div class="collapse " id="regulatory-intelligence-an-innovative-approach-to-rare-disease-clinical-development-10630" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#regulatory-intelligence--eu-clinical-trials-regulation-10631"></span> <a href="/insights/regulatory-intelligence/eu-clinical-trials-regulation" data-drupal-link-system-path="node/33650">EU Clinical Trials Regulation</a> <div class="collapse " id="regulatory-intelligence--eu-clinical-trials-regulation-10631" > <ul class="menu menu-level-2"> <li> <a href="/insights/regulatory/eu-ctr/ema-guideline-on-computerised-systems-and-electronic-data" data-drupal-link-system-path="node/33648">EMA guideline on computerised systems and electronic data in clinical trials</a> <div class="collapse " id="eu-clinical-trials-regulation-ema-guideline-on-computerised-systems-and-electronic-data-in-clinical-trials-10632" > </div> </li> <li> <a href="/insights/regulatory/eu-ctr/eu-clinical-trials-regulation" data-drupal-link-system-path="node/33649">EU CTR Whitepaper</a> <div class="collapse " id="eu-clinical-trials-regulation--eu-ctr-whitepaper-10633" > </div> </li> </ul> </div> </li> <li> <a href="/insights/regulatory-intelligence/accelerate-regulatory-document-writing" data-drupal-link-system-path="node/33645">Using innovative tools and lean writing processes to accelerate regulatory document writing</a> <div class="collapse " id="regulatory-intelligence---using-innovative-tools-and-lean-writing-processes-to-accelerate-regulatory-document-writing-10634" > </div> </li> <li> <a href="/insights/regulatory-intelligence/current-overview-data-sharing-within-clinical-trial-transparency" data-drupal-link-system-path="node/33647">Current overview of data sharing within clinical trial transparency</a> <div class="collapse " id="regulatory-intelligence----current-overview-of-data-sharing-within-clinical-trial-transparency-10635" > </div> </li> <li> <a href="/insights/regulatory/global-agency-meetings" data-drupal-link-system-path="node/33658">Global Agency Meetings: A collaborative approach to drug development</a> <div class="collapse " id="regulatory-intelligence-----global-agency-meetings-a-collaborative-approach-to-drug-development-10643" > </div> </li> <li> <a href="/insights/regulatory-intelligence/keeping-end-mind-key-considerations-creating-plain-language" data-drupal-link-system-path="node/33660">Keeping the end in mind: key considerations for creating plain language summaries</a> <div class="collapse " id="regulatory-intelligence------keeping-the-end-in-mind-key-considerations-for-creating-plain-language-summaries-10644" > </div> </li> <li> <a href="/insights/regulatory-intelligence/navigating-orphan-drug-development-early-phase-marketing" data-drupal-link-system-path="node/33661">Navigating orphan drug development from early phase to marketing authorisation</a> <div class="collapse " id="regulatory-intelligence-------navigating-orphan-drug-development-from-early-phase-to-marketing-authorisation-10645" > </div> </li> <li> <a href="/insights/regulatory-intelligence/procedural-and-regulatory-know-how-china-biotechs-eu" data-drupal-link-system-path="node/33662">Procedural and regulatory know-how for China biotechs in the EU</a> <div class="collapse " id="regulatory-intelligence--------procedural-and-regulatory-know-how-for-china-biotechs-in-the-eu-10646" > </div> </li> <li> <a href="/insights/regulatory/race-act" data-drupal-link-system-path="node/33663">RACE for Children Act</a> <div class="collapse " id="regulatory-intelligence---------race-for-children-act-10647" > </div> </li> <li> <a href="/insights/regulatory/regulatory-considerations-for-biotech" data-drupal-link-system-path="node/33665">Early engagement and regulatory considerations for biotech</a> <div class="collapse " id="regulatory-intelligence----------early-engagement-and-regulatory-considerations-for-biotech-10649" > </div> </li> <li> <a href="/insights/regulatory-intelligence/regulatory-intelligence-newsletter" data-drupal-link-system-path="node/33666">Regulatory Intelligence Newsletter</a> <div class="collapse " id="regulatory-intelligence-----------regulatory-intelligence-newsletter-10650" > </div> </li> <li> <a href="/insights/regulatory-intelligence/requirements-strategy-considerations-within-clinical-trial" data-drupal-link-system-path="node/33667">Requirements & strategy considerations within clinical trial transparency</a> <div class="collapse " id="regulatory-intelligence------------requirements-strategy-considerations-within-clinical-trial-transparency-10651" > </div> </li> <li> <a href="/insights/regulatory/spotlight-on-regulatory-reforms-in-china" data-drupal-link-system-path="node/33668">Spotlight on regulatory reforms in China</a> <div class="collapse " id="regulatory-intelligence-------------spotlight-on-regulatory-reforms-in-china-10652" > </div> </li> <li> <a href="/insights/regulatory-intelligence/demystifying-eu-ctr-mdr-and-ivdr" data-drupal-link-system-path="node/41206">Demystifying EU CTR, MDR and IVDR</a> <div class="collapse " id="regulatory-intelligence--------------demystifying-eu-ctr-mdr-and-ivdr-11541" > </div> </li> <li> <a href="/insights/regulatory-intelligence/transfer-marketing-authorisation" data-drupal-link-system-path="node/33669">Transfer of marketing authorisation</a> <div class="collapse " id="regulatory-intelligence---------------transfer-of-marketing-authorisation-10653" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights-10654"></span> <a href="/insights/therapeutics" data-drupal-link-system-path="node/33684">Therapeutics insights</a> <div class="collapse " id="therapeutics-insights-10654" > <ul class="menu menu-level-1"> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights-endocrine-and-metabolic-disorders-11081"></span> <a href="/insights/therapeutics/endocrine-and-metabolic-disorders" data-drupal-link-system-path="node/39061">Endocrine and Metabolic Disorders</a> <div class="collapse " id="therapeutics-insights-endocrine-and-metabolic-disorders-11081" > <ul class="menu menu-level-2"> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#endocrine-and-metabolic-disorders-obesity-10573"></span> <a href="/insights/therapeutics/endocrine-and-metabolic-disorders/obesity" data-drupal-link-system-path="node/33696">Obesity</a> <div class="collapse " id="endocrine-and-metabolic-disorders-obesity-10573" > <ul class="menu menu-level-3"> <li> <a href="/insights/therapeutics/endocrine-and-metabolic-disorders/obesity/addressing-obesitys-impact" data-drupal-link-system-path="node/33695">Addressing obesity's impact across the disease spectrum</a> <div class="collapse " id="obesity-addressing-obesity-s-impact-across-the-disease-spectrum-10574" > </div> </li> <li> <a href="/insights/therapeutics/endocrine-and-metabolic-disorders/obesity/trends-and-challenges-in-obesity-research" data-drupal-link-system-path="node/33697">Trends and challenges in obesity research and clinical trials</a> <div class="collapse " id="obesity--trends-and-challenges-in-obesity-research-and-clinical-trials-10575" > </div> </li> </ul> </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights--cardiovascular-10655"></span> <a href="/insights/therapeutics/cardiovascular" data-drupal-link-system-path="node/33670">Cardiovascular</a> <div class="collapse " id="therapeutics-insights--cardiovascular-10655" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/cardiovascular/mitigating-the-impact-of-covid19-on-cardiovascular-trials" data-drupal-link-system-path="node/33671">Mitigating the impact of COVID-19 on cardiovascular trials</a> <div class="collapse " id="cardiovascular-mitigating-the-impact-of-covid-19-on-cardiovascular-trials-10656" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights---cell-and-gene-therapies-10657"></span> <a href="/insights/therapeutics/cell-and-gene-therapies" data-drupal-link-system-path="node/33674">Cell and Gene Therapies</a> <div class="collapse " id="therapeutics-insights---cell-and-gene-therapies-10657" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/cell-and-gene-therapies/approaching-the-car-t-cell-therapy-horizon" data-drupal-link-system-path="node/33672">Approaching the CAR T-cell therapy horizon</a> <div class="collapse " id="cell-and-gene-therapies-approaching-the-car-t-cell-therapy-horizon-10658" > </div> </li> <li> <a href="/insights/therapeutics/cell-and-gene-therapies/cell-and-gene-therapy-clinical-trials" data-drupal-link-system-path="node/33673">Cell and Gene ebook</a> <div class="collapse " id="cell-and-gene-therapies--cell-and-gene-ebook-10659" > </div> </li> <li> <a href="/insights/therapeutics/cell-and-gene-therapies/long-term-follow-up-studies-of-cell-and-gene-therapies" data-drupal-link-system-path="node/33675">Long-term follow-up studies of cell and gene therapies</a> <div class="collapse " id="cell-and-gene-therapies---long-term-follow-up-studies-of-cell-and-gene-therapies-10660" > </div> </li> <li> <a href="/insights/therapeutics/cell-and-gene-therapies/mainstreaming-cell-gene-therapies" data-drupal-link-system-path="node/33676">Mainstreaming Cell & Gene Therapies</a> <div class="collapse " id="cell-and-gene-therapies----mainstreaming-cell-gene-therapies-10661" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights----central-nervous-system-10662"></span> <a href="/insights/therapeutics/central-nervous-system" data-drupal-link-system-path="node/33679">Central Nervous System</a> <div class="collapse " id="therapeutics-insights----central-nervous-system-10662" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/central-nervous-system/a-mind-for-digital-therapeutics" data-drupal-link-system-path="node/33677">A mind for digital therapeutics</a> <div class="collapse " id="central-nervous-system-a-mind-for-digital-therapeutics-10663" > </div> </li> <li> <a href="/insights/therapeutics/central-nervous-system/challenges-and-opportunities-in-traumatic-brain-injury-clinical-trials" data-drupal-link-system-path="node/33678">Challenges and opportunities in traumatic brain injury clinical trials</a> <div class="collapse " id="central-nervous-system--challenges-and-opportunities-in-traumatic-brain-injury-clinical-trials-10664" > </div> </li> <li> <a href="/insights/therapeutics/central-nervous-system/key-considerations-for-parkinsons-disease-trials" data-drupal-link-system-path="node/33680">Challenges and opportunities in Parkinson’s Disease clinical trials</a> <div class="collapse " id="central-nervous-system---challenges-and-opportunities-in-parkinson-s-disease-clinical-trials-10665" > </div> </li> <li> <a href="/insights/therapeutics/central-nervous-system/key-considerations-in-chronic-pain-clinical-trials" data-drupal-link-system-path="node/33681">Key Considerations in Chronic Pain Clinical Trials</a> <div class="collapse " id="central-nervous-system----key-considerations-in-chronic-pain-clinical-trials-10666" > </div> </li> </ul> </div> </li> <li> <a href="/insights/therapeutics/glycomics" data-drupal-link-system-path="node/33683">Glycomics</a> <div class="collapse " id="therapeutics-insights-----glycomics-10668" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights------infectious-diseases-10669"></span> <a href="/insights/therapeutics/infectious-diseases" data-drupal-link-system-path="node/33690">Infectious Diseases</a> <div class="collapse " id="therapeutics-insights------infectious-diseases-10669" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/infectious-diseases/antimicrobial-resistance" data-drupal-link-system-path="node/33685">Antimicrobial Resistance</a> <div class="collapse " id="infectious-diseases-antimicrobial-resistance-10670" > </div> </li> <li> <a href="/therapeutics/therapeutics-insights/infectious-diseases/considerations-strengthening-vaccine" data-drupal-link-system-path="node/33686">Considerations for strengthening vaccine development</a> <div class="collapse " id="infectious-diseases--considerations-for-strengthening-vaccine-development-10671" > </div> </li> <li> <a href="/insights/therapeutics/infectious-diseases/covid-19-vaccine-trials" data-drupal-link-system-path="node/33687">COVID-19 vaccine trials</a> <div class="collapse " id="infectious-diseases---covid-19-vaccine-trials-10672" > </div> </li> <li> <a href="/insights/therapeutics/infectious-diseases/covid-19-vaccines-pass" data-drupal-link-system-path="node/33688">COVID-19 vaccines: Post-authorisation safety surveillance</a> <div class="collapse " id="infectious-diseases----covid-19-vaccines-post-authorisation-safety-surveillance-10673" > </div> </li> <li> <a href="/insights/therapeutics/infectious-diseases/hiv" data-drupal-link-system-path="node/33689">HIV</a> <div class="collapse " id="infectious-diseases-----hiv-10674" > </div> </li> <li> <a href="/insights/therapeutics/infectious-diseases/the-value-of-dynamic-transmission-models" data-drupal-link-system-path="node/33691">The value of dynamic transmission models</a> <div class="collapse " id="infectious-diseases------the-value-of-dynamic-transmission-models-10675" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights-------nash-10677"></span> <a href="/insights/therapeutics/nash" data-drupal-link-system-path="node/33693">NASH</a> <div class="collapse " id="therapeutics-insights-------nash-10677" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/nash/the-voice-of-nash-investigators-in-patient-recruitment" data-drupal-link-system-path="node/33694">The voice of NASH investigators</a> <div class="collapse " id="nash-the-voice-of-nash-investigators-10678" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights--------oncology-10682"></span> <a href="/insights/therapeutics/oncology" data-drupal-link-system-path="node/33698">Oncology</a> <div class="collapse " id="therapeutics-insights--------oncology-10682" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/oncology/icon-survey-report-innovation-oncology" data-drupal-link-system-path="node/40826">ICON survey report: Innovation in Oncology</a> <div class="collapse " id="oncology-icon-survey-report-innovation-in-oncology-11406" > </div> </li> <li> <a href="/insights/therapeutics/oncology/de-risking-clinical-development-precision-medicines" data-drupal-link-system-path="node/40831">De-risking clinical development of precision medicines in oncology</a> <div class="collapse " id="oncology--de-risking-clinical-development-of-precision-medicines-in-oncology-11411" > </div> </li> <li> <a href="/insights/therapeutics/oncology/advances-imaging-biomarkers-estimating-drug-efficacy-tumour" data-drupal-link-system-path="node/41156">Advances in imaging biomarkers: Estimating drug efficacy with tumour growth rate modelling</a> <div class="collapse " id="oncology---advances-in-imaging-biomarkers-estimating-drug-efficacy-with-tumour-growth-rate-modelling-11536" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights---------paediatrics-10683"></span> <a href="/insights/therapeutics/pediatrics" data-drupal-link-system-path="node/33699">Paediatrics</a> <div class="collapse " id="therapeutics-insights---------paediatrics-10683" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/pediatrics/pediatric-risk-assessment-map" data-drupal-link-system-path="node/33700">Paediatric Risk Assessment Map</a> <div class="collapse " id="paediatrics-paediatric-risk-assessment-map-10684" > </div> </li> </ul> </div> </li> <li> <a href="/insights/therapeutics/respiratory" data-drupal-link-system-path="node/40721">Respiratory</a> <div class="collapse " id="therapeutics-insights----------respiratory-11351" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#therapeutics-insights-----------rare-and-orphan-diseases-10685"></span> <a href="/insights/therapeutics/rare-and-orphan-diseases" data-drupal-link-system-path="node/33706">Rare and orphan diseases</a> <div class="collapse " id="therapeutics-insights-----------rare-and-orphan-diseases-10685" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/advanced-therapies-for-rare-diseases" data-drupal-link-system-path="node/33701">Advanced therapies for rare diseases</a> <div class="collapse " id="rare-and-orphan-diseases-advanced-therapies-for-rare-diseases-10686" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/cross-border-enrollment-of-rare-disease-patients" data-drupal-link-system-path="node/33702">Cross-border enrollment of rare disease patients</a> <div class="collapse " id="rare-and-orphan-diseases--cross-border-enrollment-of-rare-disease-patients-10687" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/crossing-the-finish-line" data-drupal-link-system-path="node/33703">Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases</a> <div class="collapse " id="rare-and-orphan-diseases---crossing-the-finish-line-why-effective-participation-support-strategy-is-critical-to-trial-efficiency-and-success-in-rare-diseases-10688" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/diversity-equity-and-inclusion-in-rare-disease-trials" data-drupal-link-system-path="node/33704">Diversity, equity and inclusion in rare disease clinical trials</a> <div class="collapse " id="rare-and-orphan-diseases----diversity-equity-and-inclusion-in-rare-disease-clinical-trials-10689" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/identify-and-mitigate-risks-to-rare-disease-clinical-programmes" data-drupal-link-system-path="node/33705">Identify and mitigate risks to rare disease clinical programmes</a> <div class="collapse " id="rare-and-orphan-diseases-----identify-and-mitigate-risks-to-rare-disease-clinical-programmes-10690" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/leveraging-historical-data-for-use-in-rare-disease-trials" data-drupal-link-system-path="node/33707">Leveraging historical data for use in rare disease trials</a> <div class="collapse " id="rare-and-orphan-diseases------leveraging-historical-data-for-use-in-rare-disease-trials-10691" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/natural-history-studies-to-improve-drug-development-in-rare-diseases" data-drupal-link-system-path="node/33708">Natural history studies to improve drug development in rare diseases</a> <div class="collapse " id="rare-and-orphan-diseases-------natural-history-studies-to-improve-drug-development-in-rare-diseases-10692" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/patient-centricity-in-orphan-drug-development" data-drupal-link-system-path="node/33709">Patient Centricity in Orphan Drug Development</a> <div class="collapse " id="rare-and-orphan-diseases--------patient-centricity-in-orphan-drug-development-10693" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/the-key-to-remarkable-rare-disease-registries" data-drupal-link-system-path="node/33710">The key to remarkable rare disease registries</a> <div class="collapse " id="rare-and-orphan-diseases---------the-key-to-remarkable-rare-disease-registries-10694" > </div> </li> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/therapeutic-spotlight-precision-medicine" data-drupal-link-system-path="node/40986">Therapeutic spotlight: Precision medicine considerations in rare diseases</a> <div class="collapse " id="rare-and-orphan-diseases----------therapeutic-spotlight-precision-medicine-considerations-in-rare-diseases-11466" > </div> </li> </ul> </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#transforming-trials-10695"></span> <a href="/insights/transforming-trials" data-drupal-link-system-path="node/33729">Transforming Trials</a> <div class="collapse " id="transforming-trials-10695" > <ul class="menu menu-level-1"> <li> <a href="/insights/transforming-trials/accelerating-biotech-innovation" data-drupal-link-system-path="node/34264">Accelerating biotech innovation from discovery to commercialisation</a> <div class="collapse " id="transforming-trials-accelerating-biotech-innovation-from-discovery-to-commercialisation-10901" > </div> </li> <li> <a href="/insights/transforming-trials/ensuring-validity-clinical-outcomes-assessment-coa-data-value-rater" data-drupal-link-system-path="node/39731">Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training</a> <div class="collapse " id="transforming-trials--ensuring-the-validity-of-clinical-outcomes-assessment-coa-data-the-value-of-rater-training-11231" > </div> </li> <li> <a href="/insights/transforming-trials/linguistic-validation-of-clinical-outcomes-assessments" data-drupal-link-system-path="node/34286">Linguistic validation of Clinical Outcomes Assessments</a> <div class="collapse " id="transforming-trials---linguistic-validation-of-clinical-outcomes-assessments-10851" > </div> </li> <li> <a href="/insights/transforming-trials/optimising-biotech-funding" data-drupal-link-system-path="node/39001">Optimising biotech funding</a> <div class="collapse " id="transforming-trials----optimising-biotech-funding-11026" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#transforming-trials-----adaptive-clinical-trials-10696"></span> <a href="/insights/transforming-trials/adaptive-clinical-trials" data-drupal-link-system-path="node/33712">Adaptive clinical trials</a> <div class="collapse " id="transforming-trials-----adaptive-clinical-trials-10696" > <ul class="menu menu-level-2"> <li> <a href="/insights/transforming-trials/adaptive-clinical-trials/faster-path-to-market" data-drupal-link-system-path="node/33711">Adaptive Design: The Faster Path to Market</a> <div class="collapse " id="adaptive-clinical-trials-adaptive-design-the-faster-path-to-market-10697" > </div> </li> </ul> </div> </li> <li> <a href="/insights/transforming-trials/best-practices-to-increase-engagement-with-medical-and-scientific-poster-content" data-drupal-link-system-path="node/33713">Best practices to increase engagement with medical and scientific poster content</a> <div class="collapse " id="transforming-trials------best-practices-to-increase-engagement-with-medical-and-scientific-poster-content-10698" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#transforming-trials-------decentralised-clinical-trials-10701"></span> <a href="/insights/transforming-trials/decentralised-and-hybrid-clinical-trials" data-drupal-link-system-path="node/33718">Decentralised clinical trials</a> <div class="collapse " id="transforming-trials-------decentralised-clinical-trials-10701" > <ul class="menu menu-level-2"> <li> <a href="/insights/transforming-trials/decentralised-and-hybrid-clinical-trials/biopharma-perspective-panel-discussion" data-drupal-link-system-path="node/33716">Biopharma perspective: the promise of decentralised models and diversity in clinical trials</a> <div class="collapse " id="decentralised-clinical-trials-biopharma-perspective-the-promise-of-decentralised-models-and-diversity-in-clinical-trials-10702" > </div> </li> <li> <a href="/insights/transforming-trials/decentralised-and-hybrid-clinical-trials/decentralised-trials-plan" data-drupal-link-system-path="node/33717">Decentralised and Hybrid clinical trials</a> <div class="collapse " id="decentralised-clinical-trials--decentralised-and-hybrid-clinical-trials-10703" > </div> </li> <li> <a href="/insights/transforming-trials/decentralised-and-hybrid-clinical-trials/practical-considerations-in-transitioning-to-dct" data-drupal-link-system-path="node/33719">Practical considerations in transitioning to hybrid or decentralised clinical trials</a> <div class="collapse " id="decentralised-clinical-trials---practical-considerations-in-transitioning-to-hybrid-or-decentralised-clinical-trials-10704" > </div> </li> <li> <a href="/insights/transforming-trials/decentralised-and-hybrid-clinical-trials/regulatory-labyrinth-of-technology" data-drupal-link-system-path="node/33720">Navigating the regulatory labyrinth of technology in decentralised clinical trials</a> <div class="collapse " id="decentralised-clinical-trials----navigating-the-regulatory-labyrinth-of-technology-in-decentralised-clinical-trials-10705" > </div> </li> </ul> </div> </li> <li> <a href="/insights/transforming-trials/ecoa-implementation" data-drupal-link-system-path="node/33721">eCOA implementation</a> <div class="collapse " id="transforming-trials--------ecoa-implementation-10706" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#transforming-trials---------blended-solutions-insights-10707"></span> <a href="/insights/transforming-trials/blended-solutions-insights" data-drupal-link-system-path="node/33723">Blended solutions insights</a> <div class="collapse " id="transforming-trials---------blended-solutions-insights-10707" > <ul class="menu menu-level-2"> <li> <a href="/insights/transforming-trials/functional-model-insights/clinical-trials-in-japan-an-enterprise-growth-and-management-strategy" data-drupal-link-system-path="node/33722">Clinical trials in Japan: An enterprise growth and management strategy</a> <div class="collapse " id="blended-solutions-insights-clinical-trials-in-japan-an-enterprise-growth-and-management-strategy-10708" > </div> </li> <li> <a href="/insights/transforming-trials/functional-model-insights/investments-in-supply-of-cras" data-drupal-link-system-path="node/33724">How investments in supply of CRAs is better than competing with the demand for CRAs</a> <div class="collapse " id="blended-solutions-insights--how-investments-in-supply-of-cras-is-better-than-competing-with-the-demand-for-cras-10709" > </div> </li> <li> <a href="/insights/transforming-trials/functional-model-insights/the-evolution-of-fsp-not-just-for-large-pharma" data-drupal-link-system-path="node/33725">The evolution of FSP: not just for large pharma</a> <div class="collapse " id="blended-solutions-insights---the-evolution-of-fsp-not-just-for-large-pharma-10710" > </div> </li> <li> <a href="/insights/transforming-trials/blended-solutions-insights/embracing-blended-operating-model" data-drupal-link-system-path="node/41091">Embracing a blended operating model</a> <div class="collapse " id="blended-solutions-insights----embracing-a-blended-operating-model-11476" > </div> </li> </ul> </div> </li> <li> <a href="/insights/transforming-trials/implications-of-covid-19-on-statistical-design" data-drupal-link-system-path="node/33726">Implications of COVID-19 on statistical design and analyses of clinical studies</a> <div class="collapse " id="transforming-trials----------implications-of-covid-19-on-statistical-design-and-analyses-of-clinical-studies-10711" > </div> </li> <li> <a href="/insights/transforming-trials/improving-pharma-research-and-development-efficiency" data-drupal-link-system-path="node/33727">Improving pharma R&D efficiency</a> <div class="collapse " id="transforming-trials-----------improving-pharma-r-d-efficiency-10712" > </div> </li> <li> <a href="/insights/transforming-trials/increasing-complexity-and-declining-roi-in-drug-development" data-drupal-link-system-path="node/33728">Increasing Complexity and Declining ROI in Drug Development</a> <div class="collapse " id="transforming-trials------------increasing-complexity-and-declining-roi-in-drug-development-10713" > </div> </li> <li> <a href="/insights/transforming-trials/innovation-in-clinical-trial-methodologies" data-drupal-link-system-path="node/33730">Innovation in Clinical Trial Methodologies</a> <div class="collapse " id="transforming-trials-------------innovation-in-clinical-trial-methodologies-10714" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#transforming-trials--------------partnership-insights-10715"></span> <a href="/insights/transforming-trials/partnership-insights" data-drupal-link-system-path="node/33732">Partnership insights</a> <div class="collapse " id="transforming-trials--------------partnership-insights-10715" > <ul class="menu menu-level-2"> <li> <a href="/insights/transforming-trials/partnership-insights/exploring-partnership-culture" data-drupal-link-system-path="node/33731">Exploring partnership culture and its impact on outsourcing and operational strategy</a> <div class="collapse " id="partnership-insights-exploring-partnership-culture-and-its-impact-on-outsourcing-and-operational-strategy-10716" > </div> </li> </ul> </div> </li> <li> <a href="/insights/transforming-trials/risk-based-quality-management" data-drupal-link-system-path="node/33733">Risk Based Quality Management</a> <div class="collapse " id="transforming-trials---------------risk-based-quality-management-10717" > </div> </li> <li> <a href="/insights/transforming-trials/transforming-the-rd-model" data-drupal-link-system-path="node/33735">Transforming the R&D Model to Sustain Growth</a> <div class="collapse " id="transforming-trials----------------transforming-the-r-d-model-to-sustain-growth-10719" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#value-based-healthcare-10720"></span> <a href="/insights/value-based-healthcare" data-drupal-link-system-path="node/33746">Value Based Healthcare</a> <div class="collapse " id="value-based-healthcare-10720" > <ul class="menu menu-level-1"> <li> <a href="/insights/value-based-healthcare/strategies-commercialising-oncology-treatments-young-adults" data-drupal-link-system-path="node/40021">Strategies for commercialising oncology treatments for young adults</a> <div class="collapse " id="value-based-healthcare-strategies-for-commercialising-oncology-treatments-for-young-adults-11276" > </div> </li> <li> <a href="/insights/value-based-healthcare/US-payers-and-PROs" data-drupal-link-system-path="node/33758">US payers and PROs</a> <div class="collapse " id="value-based-healthcare--us-payers-and-pros-10721" > </div> </li> <li> <a href="/insights/value-based-healthcare/accelerated-early-clinical-manufacturing" data-drupal-link-system-path="node/33736">Accelerated early clinical manufacturing</a> <div class="collapse " id="value-based-healthcare---accelerated-early-clinical-manufacturing-10722" > </div> </li> <li> <a href="/insights/value-based-healthcare/cardiovascular-medical-devices" data-drupal-link-system-path="node/33737">Cardiovascular Medical Devices</a> <div class="collapse " id="value-based-healthcare----cardiovascular-medical-devices-10723" > </div> </li> <li> <a href="/insights/value-based-healthcare/cms-price-negotiation-for-part-d-drugs" data-drupal-link-system-path="node/33738">CMS Part D Price Negotiations: Is your drug on the list?</a> <div class="collapse " id="value-based-healthcare-----cms-part-d-price-negotiations-is-your-drug-on-the-list--10724" > </div> </li> <li> <a href="/insights/value-based-healthcare/covid-19-navigating-global-market-access" data-drupal-link-system-path="node/33739">COVID-19 navigating global market access</a> <div class="collapse " id="value-based-healthcare------covid-19-navigating-global-market-access-10725" > </div> </li> <li> <a href="/insights/value-based-healthcare/ensuring-scientific-rigor-in-external-control-arms" data-drupal-link-system-path="node/33740">Ensuring scientific rigor in external control arms</a> <div class="collapse " id="value-based-healthcare-------ensuring-scientific-rigor-in-external-control-arms-10726" > </div> </li> <li> <a href="/insights/value-based-healthcare/evidence-synthesis" data-drupal-link-system-path="node/33741">Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks</a> <div class="collapse " id="value-based-healthcare--------evidence-synthesis-a-solution-to-sparse-evidence-heterogeneous-studies-and-disconnected-networks-10727" > </div> </li> <li> <a href="/insights/value-based-healthcare/global-outcomes-benchmark" data-drupal-link-system-path="node/33742">Global Outcomes Benchmarking</a> <div class="collapse " id="value-based-healthcare---------global-outcomes-benchmarking-10728" > </div> </li> <li> <a href="/insights/value-based-healthcare/health-technology-assessm" data-drupal-link-system-path="node/33743">Health technology assessment</a> <div class="collapse " 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