Involve Health Care Provider

Opportunity

Build a continuity of care in the participant’s medical journey by involving the participant’s personal doctor in clinical trials. This may help to reduce the participant’s burden by avoiding duplication between standard of care / trial assessments and allowing clinical trial assessments to be completed locally.

Considerations to Help Action the Opportunity

• Clarify roles and responsibilities, in line with Good Clinical Practice (GCP) (e.g., that the investigative site retains responsibility for determining if events are adverse event(s) and making treatment decisions based on personal doctor data)
• Define agreements required between investigative site, personal doctor, and sponsor (as appropriate)
• Define procedures / tools to share participant’s data between site, personal doctor, and sponsor in line with data privacy requirements
• List requirements of the personal doctor to perform trial assessments (e.g., trial specific training, delegation, safety reporting, indemnity insurance, financial indemnity, documentation such as FDA 1572, etc.)
• Partner with participants to understand their acceptance and comfort having trial assessments performed by their personal doctor
• Partner with investigative sites to ensure they can manage the requirements of working with a personal doctor and can support appropriate oversight
• Partner with personal doctor as needed for trial specific requirements (e.g., training, agreements, financial considerations, etc.) 
• Understand varying levels of engagement desired by personal doctors (e.g., awareness vs. active involvement) along with engagement mapping
• Define how to empower clinical trial participants to relay appropriate information with their personal doctor including both test results with contextual ranges that could vary from standard of care 

Value and Potential Benefits

• Reduces duplication of effort between trial assessments and what a participant’s personal doctor would perform as part of the standard of care
• Allows participant to have assessments performed in their usual care setting and by a personal doctor known to, and trusted, by them
• Saves the participant time and effort by reducing visits to investigative site
• Enables the personal doctor or specialized healthcare provider to treat the participant with a holistic view of their trial and non-trial needs
• Allows continuity of care delivered before, during, and after the trial