CTTI News

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

CTTI News | August 23, 2024

Topics Included: Artificial Intelligence

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:  

Recent News Feed

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

Posted on by Hannah Faulkner

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:  

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.

CTTI Publication Explores Perceived Barriers and Recommendations Surrounding the Adoption of Decentralization

Posted on by Hannah Faulkner

Despite widespread support for decentralization, real and perceived challenges remain, limiting wider implementation of decentralized elements. A new CTTI publication, published in the Journal of Therapeutic Innovation & Regulatory Science, explores three perceptions that are commonly heard as barriers to the adoption of decentralized approaches in clinical trials. Because the integration of these approaches has the potential to enhance accessibility, diversity, and to reduce the burden on participants and caregivers, it is crucial to understand which barriers can be readily addressed with existing strategies.  

In this commentary, CTTI staff outline the three barriers to adoption, discuss the degree to which the perceived and real barriers can be overcome, and share existing resources sponsors and trial designers can use to address them. 

New CTTI Steering Committee Positions Open for Patient/Caregiver Representative(s)

Posted on by Hannah Faulkner

One of the ways that the Clinical Trials Transformation Initiative (CTTI) engages with and integrates patients into our work is by having patient/caregiver representatives on our Steering Committee. We are currently accepting applications for this position until 11:59 p.m. ET, Tuesday, April 2. We are looking for patients or caregivers who are self-starters, have personal experience and familiarity with clinical trials, and can work with stakeholders across the research community. 

During their three-year term, CTTI Steering Committee patient/caregiver representatives contribute ideas for projects, participate in their conduct and analysis, and are committed to disseminating CTTI recommendations and encouraging adoption of system changes that will improve the efficiency and quality of clinical trials. 

To learn more about this opportunity and apply, please visit the patient/caregiver page on our website.  You can also meet our current patient/caregiver representatives.