Author: Hannah Faulkner

Recent Publication Reviews How CTTI’s Digital Health Trial Hub Can Unlock the Potential of Digitalizing Trials

Posted on by Hannah Faulkner

A new CTTI publication, published in Nature Reviews Bioengineering, reviews opportunities for and challenges to using digital health technologies in clinical trials and highlights CTTI’s Digital Health Trials (DHTs) Hub. Digital health technologies have the potential to transform evidence generation in clinical trials, from trial design and participant screening to data capture and analysis. However, digital health technologies introduce new challenges, including concerns around data protection and data quality. The wide variety of available technologies requires that sponsors carefully identify meaningful measures, select and test appropriate technologies for capturing these measures, and train site staff and participants to properly use the selected technologies.

CTTI’s DHT Hub includes tools and recommendations for developing novel endpoints, planning decentralized trials, selecting and testing digital health technologies, managing data, supporting sites, and interacting with regulators. These resources support the effective implementation of DHTs to bring therapies to patients more quickly and efficiently, aligning with CTTI’s Transforming Trials 2030 vision.

Patient Engagement Collaborative (PEC) Application to Open Soon

Posted on by Hannah Faulkner

The FDA and CTTI will be accepting applications this summer from patient community representatives interested in becoming members of the Patient Engagement Collaborative (PEC). The PEC is an ongoing, shared forum where patient community representatives and regulators come together to discuss strategies for increasing patient engagement. Get ready to apply so you don’t miss your chance to join this unique group!  

Successful applicants will include:  

  • Patients who have personal disease experience  
  • Caregivers who support patients (e.g., a family member or friend) and have personal disease experience through this caregiver role  
  • Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience  

The following PDF documents are required to apply:  

  • A current and complete one- to two-page resume or bio that summarizes your patient advocacy experience and related activities (PDF format required); and    
  • A one-page professional letter of endorsement from a patient group with which you have worked closely on activities that are relevant to the PEC (PDF format required)  

A maximum of 75 applicants will be considered. If you or someone you know may be interested in applying, please check the FDA’s PEC webpage for details.  

Report Now Available: Virtual Public Workshop to Enhance Clinical Study Diversity

Posted on by Hannah Faulkner

The report of the two-day virtual public workshop to enhance clinical study diversity, convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The workshop was held on November 29 and 30, 2023 with more than 2,600 global attendees. 

The workshop solicited input on strategies and considerations for increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of diseases or conditions among demographic subgroups. Speakers and panelists included representatives from the FDA and other federal agencies, academia, medical device and pharmaceutical sponsors, patients and patient advocacy groups, and research study teams. 

The workshop fulfilled a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). View the recording and slide deck to learn more. 

FDA, CTTI Convening Hybrid Public Workshop on Artificial Intelligence in Drug & Biological Product Development

Posted on by Hannah Faulkner

The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a hybrid public workshop on the use of AI in drug and biological product development. Registration is now open for this free hybrid public workshop, which will be held both in person and virtually via Zoom.

Please join us as we discuss guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs. Drawing on real case examples, experts will discuss their rationale for particular approaches, share their methods for evaluating success, recount challenges faced, explore options for scaling and wider applicability, and outline considerations for moving forward.

The public workshop is scheduled from 10 a.m. to 5:30 p.m. EDT and is free for all to attend. Participants have the option to attend either virtually or in person at the FDA Great Room, located at 10903 New Hampshire Avenue, Silver Spring, MD 20993.

Update: As of July 16, 2024, in-person registration is now closed. Registration for virtual attendance will remain open until the workshop begins on August 6, 2024.