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New Publication by CTTI, DCRI, the Duke Margolis Institute for Health Policy, and Protas Investigates Practices to Improve Evidence Generation System in Clinical Trials

CTTI News | September 17, 2024

Topics Included: Access to Clinical Trials

A new publication developed in collaboration by CTTI, the Duke Clinical Research Institute (DCRI), the Duke Margolis Institute for Health Policy, and Protas published in Trials highlights the current barriers to clinical trial transformation, areas of improvement, and actions needed to transform clinical evidence generation in the United States to better align with clinical care demands. A modern clinical trial infrastructure should prioritize trial accessibility, answer relevant study questions reliably, respond to public health emergencies rapidly, and more. 

The article identifies three key barriers that are currently impeding the transformation of the clinical trial evidence generation system – gaps in policy, inefficient infrastructure, and a lack of research prioritization. The United States’ health and data system has a fragmented infrastructure that can hamper the progress of clinical trials, especially at locations not accustomed to participating in research. Taking advantage of tools that increase trial efficiency will help significantly improve trial activation and participation. Regulatory support and appropriate policies are needed to implement a modern clinical trial infrastructure.  

Lastly, clinical trials are often deprioritized in health care settings because incentives to participate in trials are often limited and/or misaligned with clinical care activities. Health system leadership should encourage integration of trials more routinely into care delivery and help advance a learning health care system, especially as systems implement reforms to improve their clinical data infrastructure. 

Reliable and better evidence can be generated if there is continued movement towards more simple trial designs, regulatory clarity, the creation of a sustainable systemwide infrastructure, and coordinated leadership to improve the research and health care culture. 

Recent News Feed

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.

Recent News Feed

Hybrid Public Workshop on AI in Drug and Biological Product Development

Webinars | August 22, 2024

Topics Included: Artificial Intelligence

Hybrid Public Workshop Resources:

Full Agenda

Download full PowerPoint slide set

Recent News Feed

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.

Recent News Feed

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

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.