The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.
One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.
The continuing rise of patient-centricity within the drug development industry is a crucial consideration for sponsors when designing their clinical development plans. With initiatives such as the FDAs Patient-Focused Drug Development Program, patient experience and voice within a clinical trial is becoming increasingly important.