By Tara Gladwell, VP of Operations, Rho
As the VP of Operations at Rho, a full-service, professionally managed contract research organization that delivers results from clinical research with agility and adaptability, Tara Gladwell offers her expertise explaining the top 5 reasons why clinical trials fail from an operational point of view.
#1: Challenges with Feasibility Process
- Time pressure on site personnel to respond to feasibility questions
- Devil is in the details: draft synopsis vs. final protocol
- Changes to competitive landscape
#1: Tips Leverage your investigator database
- Instead of sending generic feasibility questionnaires, focus on asking higher-quality questions of fewer sites
- Close the loop with sites not selected for your study.
- Don’t forget that site feasibility data is just one piece of the puzzle: investigator database, other databases, manuscripts, other experts.
- Be transparent about enrollment projections- set expectations from the very beginning.