Does Your Study Need to be Rescued? Know the Signs

Clinical trial rescue checklist

Does Your Study Need to be Rescued? Know the Signs

The lifecycle of a clinical trial is never a straight line. We all know the troubling statistics, like the fact that 80% of trials fail to meet enrollment timelines. It is important to know when recruitment numbers may be falling behind and to act quickly.

But how do you know when to act and chart your best course of action? The first step is to understand the factors impacting enrollment in the study. There are three common areas affecting patient enrollment that you should keep an eye on:

Protocol Problems

  • The screen failure rate is trending higher than projected
  • Poor compliance with study visits, medications, procedures, etc.
  • Poor viability of lab results
  • The requirement of a parent or caregiver is impeding consent
  • Current enrollment does not fulfill study requirements

Unsuccessful Sites

  • Start-up is lagging behind due to regulatory delays, contract negotiations, slow document follow-up or lack of study staff
  • Investigators are not making the study a priority
  • The study population and referrals exist, but the conversion rate to enrolled participants is low
  • Principal investigators are struggling to gain patient consent, many patients are approached but few enroll
  • Site point of contact doesn’t respond to calls or email
  • Study activities are not completed within the required window

Mixed Messaging

  • Patient materials are not eliciting the expected response
  • Lack of response to advertising or outreach
  • Under-delivering outreach tactics implemented to help meet enrollment goals

Once you know the problem, then you can develop a customized solution that will get the study back on track. Do you need a protocol amendment, more sites, or one-on-one site support? Will home nursing services make a difference? Or do you need to focus on a better way to identify potential participants, like using prescription data?

Contact us to discuss how UBC’s Patient and Physician Services team can help you identify and quickly implement targeted solutions to rescue your study.

Learn more about UBC’s Patient & Physician Recruitment & Retention services