Project:

Practical Approaches for Embedding Trials into Health Care Settings

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When research data is collected separately from a clinical care setting, studies may produce results that do not reflect the real-world performance of medical products in the populations that will use them. Researchers can bridge these gaps by embedding adequate and well-controlled trials into regular clinical care. The bigger question that remains is how best to facilitate the fit-for-purpose integration of interventional trials into clinical care settings.

 

CTTI is taking on this challenge by creating much needed recommendations and resources to help overcome the obstacles of integrating clinical trials intended for medical product review into clinical care – potentially resulting in better regulatory and health care decision making and improved patient care.

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Because traditional randomized controlled trials do not typically occur in a real-world clinical care setting, the data produced may not reflect the performance of medical products in the populations that will use them. Or, conversely, the trials may become inefficient and expensive if they replicate activities that already occur in clinical care.

 

Integrating components of clinical trials intended for medical product review into clinical care settings can remedy these issues. However, no evidence-based set of guidelines currently exists to help operationalize this integration. CTTI’s work in this area will create recommendations and resources to help clinical trial stakeholders embed trials into real-world clinical settings.

Practical Approaches for Embedding Trials into Health Care Settings

As part of this work, CTTI will:

  • Identify when elements of interventional clinical trial integration into clinical settings would be feasible and the associated benefits and risks
  • Identify the barriers and potential solutions to incorporating interventional trials into clinical care settings.
  • Describe the operational approaches to incorporating interventional trials into clinical care settings.

Results from this project will improve clinical evidence generation through the broad integration of clinical trials into clinical care.

The project team will engage in the following activities to support the project objectives:

  • Interview sponsors, research sites, and stakeholders across healthcare settings on their concerns and willingness to integrate interventional trials into clinical care.
  • Compile case studies of select randomized and non-randomized trials intended for medical product review that describe operational approaches to incorporating interventional trials into clinical care settings.
  • Convene a multi-stakeholder meeting to discuss issues and strategies.

The Practical Approaches for Embedding Trials into Health Care Settings project is expected to yield the following:

  • Best practice recommendations and manuscript
  • Summary of interview results and manuscript
  • Multi-stakeholder meeting summary
  • Collection of case studies

Project Team Members

Role Name Affiliationsort descending
Team Member James Riddle Advarra
Team Member Suanna Bruinooge American Society of Clinical Oncology
Team Member Victoria Gamerman Boehringer Ingelheim
Communications Lead Rae Holliday Clinical Trials Transformation Initiative
Project Manager Lindsay Kehoe Clinical Trials Transformation Initiative
Social Science Lead Amy Corneli Clinical Trials Transformation Initiative
Team Member Cecile Norris Crohn's & Colitis Foundation
Team Member Louis Fiore Department of Veterans Affairs
EC Champion John Alexander Duke University
Team Member Marcy Kravet EMD Serono
Team Member Jeffrey Roberts Food and Drug Administration/CBER
Team Member Heather Stone Food and Drug Administration/CDER
Team Member Pablo Morales Food and Drug Administration/CDRH
Team Member Maureen Dreher Food and Drug Administration/OC
Team Leader Mark Stewart Friends of Cancer Research
Team Member Holly Robertson Medidata Solutions
Team Leader Sam Bozzette National Institutes of Health
Team Member MarieElena Cordisco Nuvance
Team Member Daniel Rose Pulmonary Fibrosis Foundation
Team Leader David Thompson Syneos Health
Team Member Sabrina Comic-Savic TrialsPark
Team Member Greg Licholai Yale University