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CTTI Selected to Support FDA Efforts to Increase Patient Engagement Through New Collaborative
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CTTI Project: Patient Engagement Collaborative
CTTI has been engaged by the U.S. Food and Drug Administration (FDA) to support its Patient Engagement Collaborative (PEC), an effort created in partnership with CTTI to bring together members of the patient community to discuss the best ways for patients to participate in the FDA’s regulatory discussions about medical products.
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CTTI Names Sally Okun as New Executive Director
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The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA), today announced Sally Okun as its new executive director.
CTTI Takes on Site Investigator Turnover in New Recommendations
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CTTI Project: Investigator Community
The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.
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CTTI Launches New Online Digital Health Trials Hub
CTTI Project: Developing Novel Endpoints, Planning Decentralized Trials
Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.
Clinical Trials Transformation Initiative Releases New Recommendations and Tools for Improving Patient Recruitment in Clinical Trials
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CTTI Project: Recruitment
CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment that are now available to download. Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market. The foundational principle for this new approach is that recruitment planning should be started earlier in the clinical trial development process and continue throughout the implementation.
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Clinical Trial Sponsors Fail to Report Results to Participants, Public
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CTTI Project: Safety Reporting
Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publically available, according to Duke Medicine researchers.
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Children Underrepresented in Drug Studies
CTTI Project: ABDD Peds Trials
The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis of public-access data conducted by researchers at Duke University.
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Clinical Trials Transformation Initiative (CTTI) Forms Patient Leadership Council to Help Drive Improvements in Clinical Trials
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CTTI Project: Patient Engagement
As part of an effort to improve the way clinical trials are conducted, the Clinical Trials Transformation Initiative (CTTI) has formed a 16-member council to engage patient advocates in its mission.
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Cancer Studies Often Lack Necessary Rigor to Answer Key Questions
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CTTI Project: State of Clinical Trials
Fueled in part by an inclination to speed new treatments to patients, research studies for cancer therapies tend to be smaller and less robust than for other diseases.
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