Article | July 28, 2014

Top 5 Reasons Clinical Trials Fail (Operational Factors)

Source: Rho
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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.