Those who have experience with clinical trials are aware that feasibility is a short study specific questionnaire, which is sent to potential sites as part of site selection process. Usually the feasibility is asking specific questions about patient population, standard of care, local regulatory processes and available facilities and resources at the site. However, usually feasibility stage is often considered as part of Sponsor’s site selection process, while in reality this is the stage when the site evaluates if they want to do the proposed study.

Upon final signed confidentiality agreement hospitals’ clinical trials teams receive feasibility, study protocol and Investigational Brochure, which contains product specific information. Clinical trials teams very often overlook this initial step and it is common consultants to accept quickly new studies without further discussions. 

Why it is important to ask the right questions at feasibility stage?

  • It is important to understand the study requirements before making commitment.
  • Although the study title may sound straightforward there may be lots of complications in the protocol that will prevent recruitment.
  • Protocol may not fit hospital’s standard of care guidance.
  • Eligibility criteria may be very restrictive.
  • If the study is already running and the Sponsor is looking for more sites it is important to understand the reasons for adding new sites.
  • Discuss with all departments involved if they will be willing to work on the study.
  • Estimate the resources required to run the study.
  • Check your current patients to confirm they will be eligible to participate in the study and give realistic recruitment figure.
  • Check with your regulatory team how long it will take to set up the study and receive all approvals.
  • Make sure the budget is adequate to cover amount of work involved.
  • Check if there are competing studies in your department.
  • Take time to familiarize with the product and adverse events.

What could happen if the clinical trial teams do not perform proper evaluation of the study?

  • Patients do not benefit from the new treatment.
  • Low recruitment.
  • Increased workload and pressure from Sponsors and hospital administration.
  • Lack of financial return.
  • Damaged hospital reputation.
  • Better and more beneficial studies are not selected.
  • Hospital not selected from the Sponsor in future studies.

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Originally published on 1 May 2015