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Ensuring first-time quality: why Parexel looks for investigator and site feedback when planning trials

by Milly Ramdeen, Director, Strategic Feasibility, Parexel

As investigators or study coordinators you understand implicitly the challenges of enrolling patients into a clinical trial. These are far reaching and go beyond whether the planned trial is of scientific interest or is a potential treatment which could change the future standard of care.  Considerations include:

  • How many other trials are competing for your time or for your patients?
  • How complex are the required protocol procedures?
  • Are there logistical challenges with the drug?
  • Is the safety record of the product of concern?
  • How easy is this sponsor or CRO to work with? 
  • Will patients be able to remain in the trial for the required duration and manage the length and volume of visits?
  • What other treatment or trial options are available for my patients outside of this trial?

Parexel’s feasibility team consider these and other crucial elements focused on trial risk, that could impact downstream trial planning from the moment a sponsor provides a study concept or protocol synopsis to review.

While we invest heavily in and prioritize a data-driven approach to feasibility in trial planning, we understand the success or failure of a trial will depend heavily on factors related to human motivation that can be described by ‘RUBI’ – Risk (of participating), Unmet (medical) need, (potential) Benefit and Inconvenience. This is why we often contact you for feedback on patient access and challenges, standard treatment approach and care pathways, enrollment barriers and other key risks that we want to examine more deeply - before we start the trial.

We prioritize your ideas and feedback to support the development of a credible study strategy, but we also listen to your feedback about the way that we do this.

Investigators have commented that we contact them frequently and sometimes it is not clear why we are doing so or at what stage the trial is. As a result, we are trying to limit the frequency of contacts and types of request that reach your sites.  In turn, we are in the process of updating the look and feel of our online feasibility surveys to make it clear whether you are being contacted as a potential investigator site for a trial that we are running (surveys highlighted as ‘site evaluation’) or whether we seek your insights to enable us to make the optimal decisions about which countries a trial should be placed in, or to put in place specific strategies to make the trial’s implementation more smooth (Study and Country feasibility surveys). 

Our goal is always to ensure we have adequately exposed trial risks so that we can put proactive plans in place to support efficient trial completion, enabling decision makers to progress (or halt) a product’s development in the shortest possible time.

We welcome your feedback on ways to enhance our collaboration during the feasibility process on Parexel-managed studies.  Please feel free to contact me at camilla.ramdeen@parexel.com. Look forward to hearing from you.