Launched by PHT, a provider of technologies used to collect patient-driven eData for clinical research, the new FDA Roadmap App is the first mobile app designed to help sponsors navigate the Roadmap to Patient-Focused Outcome Measurement in Clinical Trials, released by the FDA in conjunction with its Clinical Outcome Assessment Qualification Program. The program and roadmap highlight the process by which a sponsor should consider, choose and/or develop a patient-focused outcome measurement strategy in a clinical program.
The mobile app optimizes the roadmap for Android phones and tablets. The purpose of the roadmap is to help trial sponsors improve clinical research that collects patient data through understanding the disease or condition, conceptualizing the treatment benefit resulting in identification of the targeted context of use (COU) and concept of interest (COI) for future clinical trial measurement.
Sheila Rocchio, MBA, PHT vice president of marketing and product management, said, “Clinical trials are including more patient reported outcomes (PROs) since the publication of the FDA’s PRO Guidance in 2009. PHT has a mission to help researchers capture the voice of the patient and incorporate more patient-driven outcomes into research. The new app makes it easy for clinical research professionals to rapidly and easily reference this new roadmap content.”