At the beginning of April 2023, the FDA published a draft of the fourth in a series of Guidance Documents entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments (COA) Into Endpoints For Regulatory Decision-Making”.  Once finalized these four documents will be combined and will replace the 2009 Guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims”.  Part 3, which was released in draft in June 2022, provides advice around the development and validation of new COA (including the modification of existing COA).

‍

Since 2018, Medable has grown a network of patients, caregivers, and care partners whose job is to help improve the clinical trial experience for participants.

Known as the Patient Caregiver Network (PCN), they regularly update their best practices, including recently refreshing their technological best practices around deploying eConsent.

We’re sharing them below to help continually promote the participant's voice and to help foster more equitable, inclusive, and diverse clinical trials

‍

For years, clinical research sites have been vocal about the technological challenges they face conducting trials. Obstacles such as multiple disparate systems per trial, an abundance of passwords, lack of interoperability, and other issues all showcase how technology can be as significant a hindrance as it is a boon. As a recent Forbes article suggests, if clinical research technology doesn’t empower sites, it risks slowing down the entire trial.