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Conversations Not Questionnaires: Fixing the Feasibility Process - Clinical Performance Partners

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Conversations Not Questionnaires: Fixing the Feasibility Process

03
Apr

I recently reviewed a 38-page feasibility questionnaire – what was the sponsor and CRO thinking? What site in their right mind would complete this (within a 48-hour turnaround time no less) and how can this possibly help ascertain whether a study is doable and whether a given site is a good fit for the trial? I’m always fascinated by this process and wonder about the logic behind asking sites to complete these forms “yesterday” when it takes the sponsor or CRO weeks to compile the results. Ask any site and they much prefer the opportunity to discuss the trial in a live conversation with someone who can clarify questions and put the study information into context. My all-time favorite questions to ask during the site interest evaluation and feasibility assessment process include:

  • Tell me what interests you most about this trial?
  • What 3 things will make the implementation of this trial difficult and how do you plan to overcome these challenges?
  • In prior similar trials, what did the sponsor or CRO do that made study execution successful and that you would like us to consider for this trial?
  • If time, money or resources were unlimited, what 3 things would you recommend to ensure timely and efficient enrollment?

As I continue my 15-year quest to transform the feasibility process, focus on the conversation and not the questionnaire or form. And, if you need help starting the conversation, check out this blog on the use of F.O.R.M.s in conversations:

http://www.cashartblog.com/2011/04/27/how-to-start-a-conversation-with-anyone-and-know-what-to-say/