Projects

CTTI’s Trials in Clinical Practice Resources are Valuable for Those Looking to Design and Conduct Randomized Trials that Integrate into Routine Clinical Practice

CTTI News | September 23, 2024

Topics Included: Data Collecting and Reporting, Innovative Trials, Site Planning

The FDA recently issued new guidance titled “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry.” Those looking to put concepts from the guidance into action will find a range of valuable resources in CTTI’s Trials in Clinical Practice Toolkit. From recommendations and a site feasibility tool to case examples, these resources provide organizations and individuals with actionable operational and trial design considerations noted in the guidance. 

CTTI Senior Project Manager Lindsay Kehoe provides further insight in the recent Clinical Leader article, “Putting It Into Practice: Why We Need Embedded Clinical Trials,” highlighting the need to incorporate elements like randomization and informed consent from trials into clinical practice to bridge the gap between research and practice. She underscores the potential for this integration to lead to a boost in knowledge, reduction in duplication of resources, and ultimately, enhanced patient care. Kehoe suggests that integration of trial elements is not all or none, benefits can be seen regardless of their number, and emphasizes the need for data to be relevant and reliable. She concludes that the success of this integration hinges on several factors: access to appropriate data, alignment of trial design with clinical workflow, preparedness of sites, clear accountability, and increased awareness of the value of research. 

The new guidance also emphasizes following a Quality by Design approach to streamline trials and proactively address risks of important errors. CTTI has developed a comprehensive Quality by Design toolkit, including recommendations, a principles document, and various resources that can help support implementation. 

More information about CTTI’s Trials in Clinical Practice & Quality by Design work is available on CTTI’s website.

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

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.