Understanding Clinical Trials: Why Are They Important for Drug Development?

<!DOCTYPE html> <html lang="en" dir="ltr"> <head> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <meta charset="utf-8" /> <meta name="description" content="Read time: 3 minutes.This is Part 1 in a 3-part series explaining how new drugs and treatments get approved to treat lung cancer. Parts 2 and 3 will be published in the coming weeks.Have you ever wondered how a new medicine or drug to treat lung cancer is brought to the people who need it? That’s what clinical trials help us do." /> <link rel="canonical" href="https://gateway.lungevity.org/understanding-clinical-trials-why-are-they-important-drug-development" /> <meta name="Generator" content="Drupal 10 (https://www.drupal.org)" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <link rel="icon" href="/themes/custom/lungevity/favicon.ico" type="image/vnd.microsoft.icon" /> <script src="/sites/default/files/google_tag/gateways_google_tag/google_tag.script.js?sn7zlz" defer></script> <title>Understanding Clinical Trials: Why Are They Important for Drug Development? | Patient Gateway</title>  <link rel="stylesheet" media="all" href="/sites/default/files/css/css_Xo5rswdopsp3RzhPivRec2869iH2hZLMOCQw0mC2Arc.css?delta=0&language=en&theme=lungevity&include=eJxVjlEKAjEMBS8UzZFKtg0lmibatIv19O6HLvg3D-bBxIrBDTcKhqwUsf64cQRVDsjeGc17I5U3g06rvMtYWNU30kuOgNtzcl9pSqJ8-EXc8CTg11CxO5Y-H6TX7wSl5XOkIpF9P-7oxtn1F2Be-AOwWEB_" /> <link rel="stylesheet" media="all" href="/sites/default/files/css/css_x2vc8oglihKVrbjx0t8bCfDBVaIlZ83tAWEsFFGohcY.css?delta=1&language=en&theme=lungevity&include=eJxVjlEKAjEMBS8UzZFKtg0lmibatIv19O6HLvg3D-bBxIrBDTcKhqwUsf64cQRVDsjeGc17I5U3g06rvMtYWNU30kuOgNtzcl9pSqJ8-EXc8CTg11CxO5Y-H6TX7wSl5XOkIpF9P-7oxtn1F2Be-AOwWEB_" /> </head> <body class="lungevity-org page-node-551179 section-understanding-clinical-trials-why-are-they-important-drug-development no-hero path-node page-node-type-article"> <a href="#main-content" class="visually-hidden focusable skip-link"> Skip to main content </a> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-53VQ652" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <?php /** * @file * Returns the HTML for a single Drupal page. * * Complete documentation for this file is available online. * @see https://drupal.org/node/1728148 */ ?> <header aria-label="Site header" class="header" id="header" role="banner"> <div id="header-content" class="page-max-width"> <div class="header-content"> <section class="header-section"> <div class="header-row header-row-1"> </div> <div class="header-row header-row-2 flex-grow-1 d-flex minw-100 flex-wrap flex-md-nowrap position-relative"> <div class="region-wrapper region-wrapper-left flex-fill mb-3 mb-md-0"></div> <div class="region-wrapper region-wrapper-center"></div> <div class="region-wrapper region-wrapper-right"></div> <div class="mobile-menu-btn-wrap"> <button class="navbar-toggler mobile-menu-btn hamburger hamburger--3dx-" data-toggle="collapse" data-target=".global-menu .navbar-collapse" aria-controls="navbarSupportedContent" aria-expanded="false" type="button" aria-label="Main menu toggle"> <span class="hamburger-box"> <span class="hamburger-inner"></span> </span> </button> </div> </div> </section> </div> </header> <div id="navigation"> <div class="page-max-width"> </div> </div> <div id="page" class="page-max-width"> <main class="main" id="main"> <div class="content-wrapper"> <div id="content" role="main"> <a id="main-content"></a> <div class="container-fluid"> <div class="region region-content"> <div id="block-block-content-7e841b84-2648-4cc8-a1b3-7c2946026d15" class="block block-block-content block-block-content7e841b84-2648-4cc8-a1b3-7c2946026d15"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><nav aria-labelledby="system-breadcrumb" class="breadcrumb" role="navigation"> <h2 class="visually-hidden" id="system-breadcrumb">Breadcrumb</h2> <ol> <li><a class="bookmark-back" href="https://gateway.lungevity.org/Patient Gateway/news-and-events">News and Events</a></li> </ol> </nav> </div> </div> <article data-history-node-id="551179" class="node node--type-article node--promoted node--view-mode-full"> <h1> <span class="field field--name-title field--type-string field--label-hidden">Understanding Clinical Trials: Why Are They Important for Drug Development?</span> </h1> <footer class="node__meta"> <article class="profile"> </article> <div class="node__submitted"> Posted on August 13, 2024 </div> </footer> <div class="node__content"> <div class="layout layout--onecol"> <div class="layout__region layout__region--content"> <div class="block block-layout-builder block-extra-field-blocknodearticlelinks"> </div> <div class="block block-layout-builder block-field-blocknodearticlefield-author"> <div class="field field--name-field-author field--type-string field--label-hidden field__item">Juhi Kunde, Director of Science & Research Marketing</div> </div> <div class="block block-layout-builder block-field-blocknodearticlefield-image"> <div class="field field--name-field-image field--type-image field--label-hidden field__item"> <img loading="lazy" src="/sites/default/files/2024-08/LUNGevity%20-%20FDA%20Approval%20Blog%20-%20Social%20Sharing%20%281200%20x%20630%20px%29.png.png" width="1200" height="630" alt="Title of article" /> </div> </div> <div class="block block-layout-builder block-field-blocknodearticlebody"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p><em>Read time: 3 minutes</em>.</p><p><em>This is Part 1 in a 3-part series explaining how new drugs and treatments get approved to treat lung cancer. Parts 2 and 3 will be published in the coming weeks.</em></p><p>Have you ever wondered how a new medicine or drug to treat lung cancer is brought to the people who need it? That’s what clinical trials help us do.</p><p>According to the National Cancer Institute, a clinical trial is a type of research study that tests how well new medical approaches (such as screening tests, prevention habits, or disease treatments) work in people. Sometimes, a clinical trial is called a clinical study.</p><p>Drug development often starts in a laboratory where chemical compounds (these are not drugs yet) are tested to see if they can kill cancer cells in a petri dish. When a compound passes this first test, it then moves forward and is checked to see if it can control the growth of cancer in mouse models and sometimes other animal models. Only a compound that passes these “pre-clinical” tests moves forward into a clinical trial.</p><p>There are four main phases of clinical trials. Each phase has its own purpose and goals. If those goals are met, the drug may move on to the next phase of testing.</p><img data-entity-uuid="f5543742-b27a-4a8b-aadf-9cd139f0ad61" data-entity-type="file" src="/sites/default/files/inline-images/LUNGevity%20-%20FDA%20Approval%20Blog%20-%20In-Blog%20Graphic%20%28800%20x%20825%20px%29.png.png" height="672" alt="Chart showing phases of clinical trials" width="660" class="align-center" loading="lazy"><h3>Phase 1: Is This Treatment Safe?</h3><p>Once a treatment has enough laboratory data to back it up, researchers will test the treatment in humans through a phase 1 clinical trial. This trial is considered successful if researchers can show the treatment is safe, identify side effects and determine what the appropriate dosage would be. Phase 1 clinical trials are small—often enrolling fewer than 30 people in the trial. Sometimes Phase 1 trials are referred to as first in-human trials because a treatment is being tested for the first time in a person.</p><h3>Phase 2: How Effective is This New Treatment?</h3><p>Once the drug has been deemed safe for humans, the researchers need to demonstrate that the treatment is effective at shrinking the tumor. They will also continue learning about side effects and toxicities (the extent to which medications or treatments are harmful or poisonous). The phase 2 clinical trial lays the groundwork for the larger phase 3 clinical trials.</p><h3>Phase 3: Is This Better Than Current Treatments?</h3><p>When a drug enters a phase 3 clinical trial, there is often a lot of hope and excitement surrounding the treatment. It has been proven to be safe and effective in treating the disease in a small population. The phase 3 clinical trial is a large, expensive clinical trial. The treatment is typically compared to the current treatments available. Data from a Phase 3 clinical trial is submitted to the FDA (U.S. Food and Drug Administration) for review and could be the basis of a drug being approved for patient use in the United States.</p><h3>Phase 4: Collecting Long-Term Real-World Data</h3><p>Once the treatment gets FDA approval, researchers continue to monitor the effects of treatment. This data is often referred to as post-marketing data. Phase 4 clinical trial results look at the outcomes of the treatment in the real world over long periods of time—sometimes even decades. Through these trials, we continue to gather information, and sometimes we can learn things we did not know from previous trials. Many of the lung cancer treatments used today have gone through (or are currently going through) post-marketing studies.  </p><p><em>The next question is—How do researchers decide if a clinical trial is successful? This will be answered in our next blog on clinical trial endpoints. Stay tuned!</em> </p><p><strong>If you like this type of information and want more of it, make sure to </strong><a href="https://www.lungevity.org/node/6303"><strong>sign up for our email list</strong></a><strong>.</strong></p></div> </div> <div class="block block-layout-builder block-field-blocknodearticlefield-video"> </div> </div> </div> </div> </article> </div> </div> </div> </div> </main> </div> <div class="add-to-any-container"> <span><strong>SHARE</strong></span>  <div class="a2a_kit a2a_kit_size_32 a2a_default_style"> <a class="a2a_button_facebook"></a> <a class="a2a_button_twitter"></a> <a class="a2a_button_email"></a> </div> <script async src="https://static.addtoany.com/menu/page.js"></script>  </div> <footer aria-label="Site footer" class="footer" id="footer" role="contentinfo"> <div class="page-max-width container-fluid py-4"> </div> <div class="bg-primary- page-bottom"> <div class="page-max-width container-fluid py-3"> </div> </div> </footer>  <div class="modal fade" id="modal-link-popup" tabindex="-1" aria-labelledby="" aria-hidden="true"> <div class="modal-dialog modal-lg"> <div class="modal-content rounded-0"> <div class="modal-header border-0 rounded-0"> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true"><i class="bi bi-x"></i></span> </button> </div> <div class="modal-body"> <iframe frameborder="0" allowfullscreen="" src="" class="modal-link-iframe"></iframe> </div> </div> </div> </div> </div>  <script type='text/javascript'> (function(){var g=function(e,h,f,g){ this.get=function(a){for(var a=a+"=",c=document.cookie.split(";"),b=0,e=c.length;b<e;b++){for(var d=c[b];" "==d.charAt(0);)d=d.substring(1,d.length);if(0==d.indexOf(a))return d.substring(a.length,d.length)}return null}; this.set=function(a,c){var b="",b=new Date;b.setTime(b.getTime()+6048E5);b="; expires="+b.toGMTString();document.cookie=a+"="+c+b+"; path=/; "}; this.check=function(){var a=this.get(f);if(a)a=a.split(":");else if(100!=e)"v"==h&&(e=Math.random()>=e/100?0:100),a=[h,e,0],this.set(f,a.join(":"));else return!0;var c=a[1];if(100==c)return!0;switch(a[0]){case "v":return!1;case "r":return c=a[2]%Math.floor(100/c),a[2]++,this.set(f,a.join(":")),!c}return!0}; this.go=function(){if(this.check()){var a=document.createElement("script");a.type="text/javascript";a.src=g;document.body&&document.body.appendChild(a)}}; this.start=function(){var t=this;"complete"!==document.readyState?window.addEventListener?window.addEventListener("load",function(){t.go()},!1):window.attachEvent&&window.attachEvent("onload",function(){t.go()}):t.go()};}; try{(new g(100,"r","QSI_S_ZN_82kRiYF2KfC6JMi", 'https://zn82kriyf2kfc6jmi-lungevity.siteintercept.qualtrics.com/SIE/?Q_ZID=ZN_82kRiYF2KfC6JMi')).start()}catch(i){}})(); </script><div id='ZN_82kRiYF2KfC6JMi'></div>  <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/551179","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"data":{"extlink":{"extTarget":true,"extTargetAppendNewWindowLabel":"(opens in a new window)","extTargetNoOverride":true,"extNofollow":false,"extNoreferrer":true,"extFollowNoOverride":false,"extClass":"0","extLabel":"(link is external)","extImgClass":false,"extSubdomains":true,"extExclude":"","extInclude":"","extCssExclude":"","extCssInclude":"","extCssExplicit":"","extAlert":false,"extAlertText":"This link will take you to an external web site. We are not responsible for their content.","extHideIcons":false,"mailtoClass":"0","telClass":"","mailtoLabel":"(link sends email)","telLabel":"(link is a phone number)","extUseFontAwesome":false,"extIconPlacement":"append","extFaLinkClasses":"fa fa-external-link","extFaMailtoClasses":"fa fa-envelope-o","extAdditionalLinkClasses":"","extAdditionalMailtoClasses":"","extAdditionalTelClasses":"","extFaTelClasses":"fa fa-phone","whitelistedDomains":["gateway.lungevity.org","kras.lungevity.org","gateway.gmhdigital.com","kras.gmhdigital.com","alk.gmhdigital.com","alk.lungevity.org"],"extExcludeNoreferrer":""}},"user":{"uid":0,"permissionsHash":"40fa630e6789206e2aaa29e437cf340cf1658df9b8019b37454faa2bafe1963b"}}</script> <script src="/sites/default/files/js/js_2cmSqYDvmlknYBbK7BHU1G1qBSYFwGaSKQbG6gQFH0Y.js?scope=footer&delta=0&language=en&theme=lungevity&include=eJzLKc1LTy3LLKnUT8_JT0rM0c0q1kmtKMnJzMvWTykqLUjM0YNyAWZsEKE"></script> </body> </html>

CINXE.COM

Understanding Clinical Trials: Why Are They Important for Drug Development? | Patient Gateway