THOUGHT LEADERSHIP

Leveraging the advantages of electronically captured patient-reported data in early phase trials

As clinical trial planning begins, PROMETRIKA Clinical Trial Managers (CTMs) and Project Managers (PMs) are often asked by Sponsors to assess the pros and cons of using paper documentation (e.g., diaries) vs. electronic data entry for patient-reported data. Our broad experience with different phases of clinical trials helps us advise Sponsors on this decision.

Drug development and clinical research methods evolve continuously through establishment of new regulations and through adaptations to changes in treatment accessibility, technology, evolving knowledge in biology, and appearance of new diseases. 

Patient-centric trials, in which the perspective of the patient is considered in study design and performance, is one such new approach in clinical research that primarily focuses on reducing patient burden. 

The number of clinical trials incorporating independent data monitoring committees (IDMCs) for safety and efficacy monitoring is on the rise. Currently, it is recommended that late-stage trials with a major morbidity or mortality endpoint, or studies in vulnerable patient populations with a large enrollment, use an IDMC to review the interim safety and efficacy data.