The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Oct. 12 & 21 to discuss the systemic changes needed to ensure that U.S. clinical trials better meet the needs of diverse populations, including racial minorities, ethnic minorities, and women. At the meeting, leaders and key stakeholders from across the clinical trials ecosystem participated in an engaging forum, informative discussions, and lively breakout sessions that shed more light on new solutions for sharing information and ensuring sufficient ...

Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products. Those selected to the PEC are expected to serve for two years. The ...

The report of the public web conference on “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” organized by International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI), is now available.  The web conference, which consisted of identical meetings at different times on May 18 & 19 to accommodate a global audience, reached more than 5100 attendees. The ICH E6 Expert Working Group (EWG) members, who are updating the guideline, presented a video ...

Today, CTTI proudly announced its new Executive Director: Sally Okun, a seasoned thought leader in clinical research, care, and policy. “Sally’s wealth of experience, distinct perspective, and passion for driving change uniquely position her as the ideal leader for CTTI at this particular time,” said Mark McClellan, chair of CTTI’s executive committee and director of the Duke-Margolis Center for Health Policy. “Throughout her career, she has brought the patient voice to many audiences in the public and private sectors in the ...

A recording of CTTI’s public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” is now available. During the webinar, presenters Lindsay Kehoe (CTTI) and Alicia Staley (Medidata) discussed CTTI’s current work to obtain reliability and acceptance of meaningful, digitally derived novel endpoints – a project that builds on CTTI’s existing novel endpoint development recommendations and resources from 2017. They also provided: Highlights from a recent Expert Meeting of leaders and stakeholders from across the clinical trials ecosystem Insights from in-depth ...

The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Aug. 25-26 to discuss best practices on conducting research in remote and virtual settings, including lessons learned from the COVID-19 pandemic. The insights gathered will be used to refresh CTTI’s 2018 Decentralized Clinical Trials (DCT) recommendations and ensure that they offer the most current information for planning and operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping). During the meeting, ...

On Oct. 5 at noon ET, the Clinical Trials Transformation Initiative (CTTI) will host a public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” – the third in a series of webinars on using novel digitally derived endpoints in clinical trials for medical product development from CTTI, Digital Medicine Society (DiMe), and TransCelerate. Presenters Lindsay Kehoe, CTTI, and Alicia Staley, Medidata, will discuss CTTI’s current work to obtain reliability and acceptance of meaningful, digitally derived novel endpoints – ...

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap, CTTI held an “Obtaining Novel Endpoint Reliability & Acceptance” Expert Meeting on July 27-28 to inform its new recommendations and resources for driving novel endpoint acceptance. Attendees discussed challenges and potential solutions to advancing the practical use of novel, digitally derived endpoints in clinical trials. They also uncovered and agreed on ...

The FDA and CTTI are currently accepting applications from patient advocates interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum that brings the patient community and regulators together to discuss ways to increase patient engagement in medical product development and regulatory discussions at the FDA. Applicants will be selected based on their ability to meaningfully contribute to the PEC, represent and express the patient voice for their constituency, work in a constructive manner with involved ...

Organizations are gaining experience using CTTI’s Quality by Design (QbD) recommendations to design and conduct better clinical trials. CTTI today announced four new QbD case studies, adding to its robust QbD toolkit. Three of the case studies are also now featured in CTTI’s recently-announced Building Better Clinical Trials: A Case Study Exchange resource. The case studies provide an in-depth look at real-word implementation of QbD principles by: Alexion, a biopharmaceutical company focused on developing medicines for rare diseases, applied QbD principles early in study design to build ...