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.
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:
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:
The Practical Approaches for Embedding Trials into Health Care Settings project is expected to yield the following:
|Team Member||James Riddle||Advarra|
|Team Member||Nirosha Mahendraratnam Lederer||Aetion|
|Team Member||Suanna Bruinooge||American Society of Clinical Oncology|
|Team Member||Victoria Gamerman||Boehringer Ingelheim|
|Team Member||Lara Jehi||Cleveland Clinic Coordinating Center for Clinical Research|
|Social Science Lead||Amy Corneli||Clinical Trials Transformation Initiative|
|Communications Lead||Rae Holliday||Clinical Trials Transformation Initiative|
|Project Manager||Lindsay Kehoe||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||Nuru Noor||Patient/Caregiver Representative|
|Team Member||Daniel Rose||Pulmonary Fibrosis Foundation|
|Team Leader||David Thompson||Syneos Health|
|Team Member||Sabrina Comic-Savic||TrialsPark|
|Team Leader||Matt Roe||Verana Health|
|Team Member||Greg Licholai||Yale University|