Improving Outcomes in Rare Disease Trials

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5.019.021.158.223.196.314.077.13-.17 1.813-2.247 2.384-4.324.162-.587.929-3.631.929-3.631.46.876 1.801 1.646 3.227 1.646 4.247 0 7.128-3.871 7.128-9.053.003-3.918-3.317-7.568-8.361-7.568z"/></svg></span></a></div><div class="heateorSssClear"></div></div> </div> </header> <div class="entry-content"> <p>Rare diseases affect around 400 million people around the world, according to the World Health Organization, which defines rare diseases as having a prevalence of one or fewer in 1,000 people. In the US, that’s around 25 to 30 million; in Europe it’s approximately 27 to 36 million, and in India, the estimate is 70 million.</p> <p>Despite rare diseases collectively accounting for a large number of people globally, individual diseases affect remarkably few patients and these are often dispersed all around the world, making these populations difficult to study.</p> <p>This post will explore some of the challenges that patients with rare diseases face as well as how difficult it is to recruit and retain patients in rare disease clinical trials. It will also highlight how by focusing on patient engagement, clinicians can both better understand patients’ needs and draw more meaningful research conclusions.</p> <p>First-Hand Account of a Rare Disease Patient<br /> Let’s start by understanding some of the struggles faced by those living with rare diseases. Medical student and rare disease patient Rebecca Nunn says mental health is a major concern for those with rare diseases.</p> <p>Indeed, in an open letter to the Orphanet Journal of Rare Diseases, Nunn notes that 69 percent of rare disease patients experience depression and 82 percent anxiety and stress. This is not surprising considering the often delayed diagnosis experienced by many people with rare conditions. Nunn’s disease took 17 years to be diagnosed correctly, and this after seeing numerous doctors throughout much of her life.</p> <p>Being accused of being a hypochondriac or diagnosed as having an untreatable anomaly, Nunn suffered for years. She says that many patients with rare diseases feel their healthcare professionals don’t trust or validate them, leading to their own mistrust of the healthcare providers.</p> <p>Added to this, it can be costly and time-consuming trying to diagnose and treat a rare disease and leaves patients feeling out of control of their lives. It’s important, then, that the clinical trial industry learn how to recruit, retain, engage and effectively treat these patients.</p> <p>Better Communication from the Outset<br /> Understanding patients and their language to enhance communication is crucial, advises Scott Schliebner, senior VP, Center for Rare Disease at PRA Health Sciences. The best way of doing this is by accessing bloggers, patient networks and advocacy websites to understand the words patients use to describe their conditions, symptoms and emotions. The goal is to find out how patients talk about healthcare providers and pharma companies and determine the challenges they face regarding their condition and past treatments.</p> <p>Schliebner also suggests using the “patient voice” to design the study. It will be challenging to translate patient feedback into study protocol, but is necessary for successful trials. Invite patients onto planning committees to provide insight in the same way as other important stakeholders do.</p> <p>network of faces representing the scope of rare disease clinical trials</p> <p>Online Patient Networks Are Influential<br /> Clinicians limited understanding of rare illnesses is a major concern, according to 3Sixty Pharma Solutions CEO Dalfoni Banerjee and Paul Burke, senior vice president at Chaucer Life Sciences. They say that even basic research into these conditions is limited as are diagnostic guidelines. The result of this lack of awareness is that patients living with rare diseases often experience a feeling of isolation.</p> <p>However, this isolation has resulted in the rise of many online communities, members of which are rare disease patients and their caregivers who are informed and engaged. Not only do these networks support patients, Banerjee and Burke argue that they exert influence over pharma companies, regulators and payers through their insights and personal knowledge helping pharma to shape orphan drug development programs and research agendas.</p> <p>The Added Recruitment Burden in Rare Disease Clinical Trials<br /> With a large number of children diagnosed with rare diseases, those who actually survive to adulthood will have experienced tremendous suffering.</p> <p>Patients with rare diseases will likely have spent a great deal of time being wrongly diagnosed, incorrectly evaluated and treated and have suffered from reduced quality of life as a result. More than that, they could well be nearing death.</p> <p>In these cases, patients are vulnerable and require a higher level of care than in other trials, which is why Michael F. Murphy, M.D., Ph.D., chief medical and scientific officer at Worldwide Clinical Trials, says recruitment and retention is especially important.</p> <p>Designing a trial protocol that acknowledges this is essential to keep patients engaged and committed to the trial. Patient-centric design, in which the patients’ experience of their disease is considered vital information, is even more important when it comes to studying rare diseases.</p> <p>For this reason, Murphy explains, trial managers and designers need to make participation as easy and informative as possible for patients.</p> <p>Strategies to Maximise Retention in Trials<br /> Patient-centricity is not just a buzzword but a real necessity to keep patients enrolled in rare disease trials, agrees Michelle Petersen, director of clinical operations at Medpace. This requires understanding the burden the study will place on patients and how to lighten it as well as determining appropriate endpoints and satisfying patients with the quality of treatment they receive.</p> <p>It also means, where possible, reducing the number of site visits by sending medication and homecare health practitioners to patients’ homes. Drug infusions, blood draws, PK sampling and minimally-invasive tests could be carried out there instead of requiring the patients to attend the site.</p> <p>Other important strategies for patient-centricity include a comprehensive risk/benefit profile and a clear consent form — perhaps in video format, which can be especially helpful for making procedures clear to pediatric patients. Also important but often forgotten is the duty of trial staff to provide comfort through helping patients access support network, counselling and organizing transport to advocacy meetings.</p> <p>Recruiting For Phase 3 Trials Are Particularly Challenging<br /> While the cost of running an orphan drug trial can be cheaper than non-orphan drugs because of its smaller sample size, it is much more challenging when it comes to recruitment, writes Samiya Luthfia Khaleel, senior research analyst at Beroe Inc.</p> <p>Approximately 30 percent of Phase 3 studies fail because of insufficient enrollment. The major factors impeding recruitment include the fact that more than 50 percent of rare diseases affect children, Khaleel says.</p> <p>And when patients are recruited, their participation is crucial, she adds. In a Phase 3 trial with 20-100 patients, for example, each patient is vital for evaluating the drug treatment and gathering data for the regulatory authorities and payers to determine pricing and reimbursement. Patient-centricity is key and should be considered when activating a trial site, Khaleel explains. For instance, where possible, prevalence of an illness should determine where a site is activated, instead of choosing multiple sites in various locations.</p> <p>The value here is lower costs and tighter timelines. However, fewer sites can mean longer travel for many patients. To counteract this, trial staff should ensure comfortable lodgings are provided and travel expenses reimbursed for patients, their caregivers and family members.</p> <p>Woman in a laboratory representing researchers working on rare disease clinical trials</p> <p>The Challenge of New Endpoints and Biomarkers<br /> With rare diseases, it can often be the case that researchers are investigating the condition for the first time. The consequence is that little is known about endpoints and biomarkers as they have not yet been validated, explains Han Phan, M.D., member of the FDA Pediatric Advisory Committee. This means researchers need to find new ways to test a treatment’s efficacy.</p> <p>Of course, supportive research and analysis can often provide sufficient assessment of efficacy, but not without risk of inaccuracy. Add to that the small number of patients experiencing the same illness and study results also run the risk of not being statistically significant.</p> <p>Patients are a wealth of information about their condition, Phan explains, so the patient voice can guide researchers and regulators in terms of understanding the balance between clinical trial results data and how treatment impacts patients’ health and quality of life.</p> <p>This is valuable when using new endpoints. Take the example of Duchenne Muscular Dystrophy (DMD) patients, Phan says. They may consider being able to use a restroom or eat a meal without assistance as a real success of treatment — a valuable insight to clinicians — even when a trial may miss a primary endpoint.</p> <p>Goal Attainment Scaling for Individualized Outcomes<br /> With rare diseases, finding more effective means of determining new endpoints is vital. This is why Kit C.B. Roes, professor of clinical trial methodology at the University Medical Centre, Utrecht in the Netherlands, argues for goal attainment scaling (GAS).</p> <p>To deal with possibly large variability between patients, GAS grants patients individualized outcomes that can still be summarized and compared within groups of patients to assess the effects of treatment.</p> <p>Consider how DMD sufferers have traditionally used the “six-minute walking test” as a default endpoint. Yet for boys with DMD, many become wheelchair-bound by the ages of eight to 10. The result is that many patients are excluded from trials because of failing this walking test.</p> <p>However, many would still benefit from treatment. This is where GAS, which focuses on individualized outcomes, can include more patients without threatening the study results, Roes explains.</p> <p>There’s an App for Rare Diseases<br /> With only 5 percent of qualified patients participating in trials and another 85 percent wanting to participate, Komathi Stem, biomedical engineer and founder of monARC Bionetworks, is hopeful that technology can change this.</p> <p>According to Stem, monARC is a smart health record technology that gathers patients’ medical records and, with a disease-specific app, allows patients to track symptoms between clinic visits. The aim is to simplify processes for patients to participate in trials — particularly remotely — and share data with researchers and family members.</p> <p>The added value, Stem says, is that pharmaceutical and device companies can rely on the data to determine the relevant endpoints.</p> <p>Rare diseases are a difficult clinical area to study, but it’s essential patients are effectively recruited, engaged and retained. Only through patient participation can researchers find answers to questions that have often plagued those living with rare diseases their whole lives.</p> </div> <ul class="cus_tags"><li ><a href="https://www.anjusoftware.com/tag/insights/" class="cus_tags_a">insights</a></li></ul> </div> </div> </main>  </div> </div>  <div class="bg-blue-gradient blog-single-banner-bottom"> <div class="container text-md-center"> <h2 class="text-white">Want to stay up to date with our news? </h2> <a href="https://www.anjusoftware.com/newsletter-subscription/"><button class="btn btn-white">Want to stay up to date with our news?</button></a> </div> </div> <div class="related_post_slider"> <div class="container"> <h3 class="related_heading">Related Posts</h3> <div class="owl-carousel owl-theme mySwiper"> <div class="item"> <a href="https://www.anjusoftware.com/insights/eclinical/streamlining-clinical-trial-operations/"> <h5>Streamlining Clinical Trial Operations: How Integrated Technology Solutions Drive 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