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We develop innovative strategies for clinical trials so that new therapies can improve the health of all the people who need them.
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<a href="/research/our-impact/our-impact-big-data" class="first" data-drupal-link-system-path="node/27395">Big Data</a>
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<a href="/research/our-impact/our-impact-clinical-trials" class="active active-trail active-trail is-active" data-drupal-link-system-path="node/27434">Clinical Trials</a>
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<a href="/research/our-impact/our-impact-drug-discovery-and-development" data-drupal-link-system-path="node/27394">Drug Discovery and Development</a>
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<a href="/research/our-impact/our-impact-rare-diseases" data-drupal-link-system-path="node/27393">Rare Diseases</a>
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<section>
|
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<div class="container news-content Advancing">
|
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<h2 class="section-heading">Shaping the Future of Clinical Trials</h2>
|
||
|
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|
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<div class="paragraph paragraph--type--body-content paragraph--view-mode--default">
|
||
|
||
|
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<div class="sidebar-right"><div class="image-box"><img src="/sites/default/files/styles/large/public/2023-09/Shaping%20the%20Future%20of%20Clinical%20Trials_720x480.png?itok=EDVOF0N6" alt="Clinician greeting patient" width="480" height="320"><div class="caption-text"><p>Richard T. Moxley, III, M.D., professor of neurology and pediatrics at the University of Rochester School of Medicine and Dentistry, visits with a patient in the Clinical Research Center participating in a myotonic dystrophy clinical trial. (<em>Vince Sullivan, University of Rochester</em>)</p></div></div></div><p>Clinical trials are a necessary step on a treatment’s journey to the medicine cabinet. But the barriers to success in clinical trials are high. A clinical trial’s design and approval can take a long time. Even after completion, a trial may not have enough participants to produce robust results, or the results don’t demonstrate that a treatment will work for everyone who needs it. </p><p>NCATS improves clinical trial practices so more safe and effective therapies can be efficiently tested and developed for the people who need them. We work with our partners to develop trial designs for testing multiple drugs and best practices for engaging the community at all stages. These approaches allowed major clinical trials for potential COVID-19 treatments to swiftly offer definitive results. </p><p>More innovative clinical trial approaches are on the horizon, especially for rare diseases. We are testing whether biomedical devices that use a patient’s own tissues could speed trial design and execution. We’re also developing a clinical trials approach that tests a single therapy on multiple diseases, as well as an approach for increasing the success of clinical trials for rare diseases.</p><p><a href="/research/our-impact">Explore All Areas of Our Impact</a></p>
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<section>
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<div class="container news-content Advancing">
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<h2 class="section-heading">Impact Stories</h2>
|
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<div class="pe-lg-4 p-0 col">
|
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|
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|
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<h2>Immune Modulator Drugs Improved Survival for People Hospitalized with COVID-19</h2>
|
||
<img src="/sites/default/files/2023-09/Clinical%20Trials%20page_Immune%20Modulators_620x275.png" class="w-100 mt-2">
|
||
<div class="description pt-4">
|
||
|
||
<p>We coordinated and oversaw the ACTIV-1 Immune Modulators clinical trial, which demonstrated improvement in survival rates.</p>
|
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<div class="text-center button-wrap">
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<button class="buttons btn-1 mt-4"><a href="/news-events/news/2022/Immune-Modulator-Drugs-Improved-Survival-for-People-Hospitalized-with-COVID-19">Read More</a></button>
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|
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|
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|
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|
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<h2>Efficient Registry Approach Powers Practice-Shaping Infant Heart Surgery Trial</h2>
|
||
<img src="/sites/default/files/2023-09/Clinical%20Trials%20page_Efficient%20Registry%20Approach_746x340.png" class="w-100 mt-2">
|
||
<div class="description pt-4">
|
||
|
||
<p>Clinical trial resources from NCATS streamlined a clinical trial study on infants undergoing surgery for congenital heart disease.</p>
|
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</div>
|
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<div class="text-center button-wrap">
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<button class="buttons btn-1 mt-4"><a href="/news-events/news/efficient-registry-approach-powers-practice-shaping-infant-heart-surgery-trial">Read More</a></button>
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<section>
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<div class="container news-content Advancing">
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<h2 class="section-heading">Clinical Trial Innovation Activities</h2>
|
||
<div class="description">
|
||
|
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<p>Our programs help turn clinical trials into meaningful results.</p>
|
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</div>
|
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<img src="/sites/default/files/2023-09/CTSA%20Related%20Research%20card_746x370_0.png" class="img-fluid">
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</div>
|
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<div class="col-xl-12 col-lg-6">
|
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<div class="card-body px-0 pt-0">
|
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<h3 class="">Clinical and Translational Science Awards (CTSA) Program</h3>
|
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<p class="py-xl-0 py-lg-4 py-md-4 py-sm-4 py-2">
|
||
|
||
<p>The CTSA Program addresses the development and implementation of national standards and best practices for translation, from basic discovery to clinical and community-engaged research.</p>
|
||
|
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</p>
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<div class="card-footer bg-white border-0 p-0">
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<a href="/research/research-activities/ctsa">Learn More</a>
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<img src="/sites/default/files/2024-05/RDCRN_746x370_0.png" class="img-fluid">
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</div>
|
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|
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<div class="card-body px-0 pt-0">
|
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<h3 class="">Rare Diseases Clinical Research Network (RDCRN)</h3>
|
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<p class="py-xl-0 py-lg-4 py-md-4 py-sm-4 py-2">
|
||
|
||
<p>We oversee this NIH-wide grant program that supports medical research on over 200 rare diseases through clinical studies, including collaborations, study enrollment and data sharing.</p>
|
||
|
||
</p>
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<div class="card-footer bg-white border-0 p-0">
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<a href="/research/research-activities/rdcrn">Learn More</a>
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<img src="/sites/default/files/2023-09/Tissue%20Chip%20Related%20Research%20card_746x370.png" class="img-fluid">
|
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</div>
|
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<div class="col-xl-12 col-lg-6">
|
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<div class="card-body px-0 pt-0">
|
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<h3 class="">Clinical Trials on a Chip</h3>
|
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<p class="py-xl-0 py-lg-4 py-md-4 py-sm-4 py-2">
|
||
|
||
<p>The Clinical Trials on a Chip program seeks to improve the success rate of new therapeutics in drug development using tissue chips.</p>
|
||
|
||
</p>
|
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|
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<div class="card-footer bg-white border-0 p-0">
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<a href="/research/research-activities/tissue-chip/projects#clinical-trials">Learn More</a>
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<div class="text-center button-wrap">
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<button class="buttons btn-1 mt-4"><a href="/research/research-activities?research_topics%5B0%5D=2">See All Clinical Trial Innovation Activities</a></button>
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</section>
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<section>
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<div class="container news-content Advancing">
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<h2 class="section-heading">Clinical Trial Innovation News</h2>
|
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|
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<div class="views-element-container"><div class="row col js-view-dom-id-4bf330e5b9a00d9a69c0a7e1373fb8e467e8af3fa746a5b9d35046fd9871b713">
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<img loading="lazy" src="/sites/default/files/styles/media_library/public/shutterstock_2352632967.jpg?itok=MAVq0a8T" width="220" height="138" alt="Cartoon of a double-helix DNA polymer and cells." />
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</div>
|
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<div class="col-md-8 col-lg-10">
|
||
<h3 class="title">New Path for a Gene Therapy Trial at NIH for a Rare Metabolic Disease</h3>
|
||
<p class="m-0"><i>November 19, 2024 - NCATS News</i>
|
||
</p>
|
||
<ul class="list-pipe">
|
||
<li><i>Bespoke Gene Therapy Consortium (BGTC)</i></li>
|
||
<li><i>Our Impact on Clinical Trials</i></li>
|
||
<li><i>Our Impact on Drug Discovery and Development</i></li>
|
||
<li><i>Our Impact on Rare Diseases</i></li>
|
||
<li><i>Platform Vector Gene Therapy (PaVe-GT)</i></li>
|
||
</ul>
|
||
|
||
|
||
<p>Scientists at NCATS and other NIH institutes and centers are teaming up to advance a gene therapy treatment for MMA, a rare and potentially life-threatening genetic disorder.</p>
|
||
|
||
<a href="https://ncats.nih.gov/news-events/news/new-path-for-a-gene-therapy-trial-at-NIH-for-a-rare-metabolic-disease">Read Article</a>
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</div>
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</div></div>
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<div class="col-sm-4 mb-4 views-row"><div class="usa-card__container">
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<h3 class="title">NIH Clinical Trial Conducted in Part at Arkansas Children’s Produces First FDA-Approved Treatment for Multiple Severe Food Allergies</h3>
|
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<p class="m-0"><i>February 29, 2024 - Grantee/Partner News</i>
|
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</p>
|
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<ul class="list-pipe">
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<li><i>Clinical and Translational Science Awards (CTSA) Program</i></li>
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<li><i>Our Impact on Clinical Trials</i></li>
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<div class="usa-card__footer">
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<a href="https://www.archildrens.org/news/releases/2024/fda-approved-food-allergy-treatment#:~:text=The%20study%20found%20that%20omalizumab,despite%20efforts%20to%20avoid%20it.">Read Article</a>
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<h3 class="title">Antibody Reduces Allergic Reactions to Multiple Foods in NIH Clinical Trial</h3>
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<p class="m-0"><i>February 25, 2024 - Grantee/Partner News</i>
|
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</p>
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<ul class="list-pipe">
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<li><i>Our Impact on Clinical Trials</i></li>
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<a href="https://www.nih.gov/news-events/news-releases/antibody-reduces-allergic-reactions-multiple-foods-nih-clinical-trial">Read Article</a>
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<div class="usa-card__body">
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<h3 class="title">CORRECTING and REPLACING Kurome Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for KME-0584 for the Treatment of Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS)</h3>
|
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<p class="m-0"><i>February 15, 2024 - Grantee/Partner News</i>
|
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</p>
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<ul class="list-pipe">
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<li><i>Our Impact on Clinical Trials</i></li>
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<li><i>Our Impact on Drug Discovery and Development</i></li>
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<a href="https://www.businesswire.com/news/home/20240215544888/en/Kurome-Therapeutics-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-KME-0584-for-the-Treatment-of-Acute-Myeloid-Lymphoma-AML-and-High-Risk-Myelodysplastic-Syndromes-MDS">Read Article</a>
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