Patient Engagement

Increasing Diversity in Clinical Trials Recommendations Launch

CTTI Project: Increasing Diversity in Clinical Trials

Webinar Presenters:

  • Richardae Araojo, U.S. Food & Drug Administration (FDA)
  • Ruma Bhagat, Genentech - a member of the Roche Group
  • Sara Calvert, CTTI
  • Luther T. Clark, Merck & Co, LLC
  • Dawn Corbett, National Institutes of Health Office of Extramural Research (OER)
  • Tesheia Johnson, Yale University
  • Jane Williams, Syneos Health
  • Glendon Zinser, Susan G. Komen

Webinar Resources:

Download PowerPoint slideset

Recording of Hybrid Public Workshop Now Available: AI in Drug and Biological Product Development v2

CTTI News | September 23, 2024

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Patient Engagement, Recruitment, Regulatory Submissions + Approvals, Safety, Site Planning

The recording for the hybrid public workshop on AI in Drug and Biological Product Development convened and hosted by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held August 6, is now available. Over 9,000 registrants from diverse backgrounds and perspectives joined to explore the responsible use of AI in drug development. 

During the workshop, we learned from experts as they discussed guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs. Drawing on real case examples, experts discussed their rationale for particular approaches, shared their methods for evaluating success, recounted challenges and obstacles, explored options for scaling and wider applicability, and outlined considerations for moving forward. Presentations can also be found here. 

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CTTI’s Newest Steering Committee Patient/Caregiver Representatives Will Support Goal to Transform Trials

CTTI News | July 22, 2024

Topics Included: Patient Engagement

A core principle of CTTI’s vision to Transform Trials 2030 is to create a collaborative, patient-centered clinical trials landscape that fully integrates patients and patient organizations into the design and governance of studies. The addition of two new Steering Committee patient/caregiver representatives, Ella Balasa and Megan O’Neil, will play a key role in this bold initiative. 

Balasa and O’Neil, as advocates for the patient/caregiver perspectives, will collaborate with existing Steering Committee members and provide essential information and viewpoints on current patient needs. They will enhance the committee by contributing ideas, helping to conduct and analyze new strategies, disseminating CTTI recommendations, and encouraging the adoption of system changes.   

Both patient representatives selected bring a wealth of experience and unique perspectives that will enrich and inform CTTI’s work to shape practices and increase the quality and efficiency of clinical trials. The contribution of these individual perspectives is essential to the system-wide transformation CTTI is making to the clinical trials landscape. 

Learn more about CTTI’s organizational structure, Steering Committee, and our Transforming Trials 2030 vision.

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Now Accepting Applications for FDA and CTTI Patient Engagement Collaborative (PEC)

CTTI News | July 9, 2024

Topics Included: Patient Engagement

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, shared forum in which the patient community (PEC members), FDA, and CTTI discuss a range of topics for enhancing communication, education, and patient engagement related to medical product regulation.    

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 relevant individuals and organizations, and understand and navigate the clinical research system. The two-year term will begin January 1, 2025.  

Successful applicants will include: 

  • Patients who have personal disease experience 
  • Caregivers who directly 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 

 PEC members participate in 5-6 virtual meetings per year. Other meetings may be organized, as needed. 

The following PDF format documents are required to apply and must be submitted at the same time: 

  • A current and complete one- to two-page resume or bio that summarizes your patient advocacy experience and related activities; 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  

A maximum of 75 applicants will be considered for PEC membership and up to eight members will be selected. Interested applicants are encouraged to complete and submit the online form starting on July 9, 2024 at 11:59 p.m. A maximum of 75 completed applications will be considered.   

Applications will be accepted until 11:59 p.m. Eastern Time on August 8, 2024 or until 75 complete applications are received, whichever happens first.     

Those who are unable to apply electronically are encouraged to call FDA Patient Affairs at 301-796-8460 to arrange for a mail submission.   

Please review the related Federal Register Notice for important information about the application process. 

For more information:  

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