RxTrials Communiqué - A Blog About Clinical Research

Thanks for the great article. I think the questions posed are very interesting and I personally believe it would be good tool for the sponsors/CRO's to place these questions on the site surveys - it would help weed out sites who don't have the proper population needed to conduct the trial. At our site, we first pull a list of subjects that meet the diagnosis criteria from our database. In this manner we obtain the gross figure. Our PI and recruiting department get involved extensively by reviewing the list, many of the subjects are well known to our doctor and that has worked in our favor (he has an incredible memory). This along with some other things, helps us narrow down the final numbers used. We do tell the sponsors where our numbers come from. Recently a sponsor had us go through the charts as part of the feasibility survey (they agreed to reimburse us for this activity regardless of whether we would be selected or not for the trial). We use a team approach when responding to the surveys.

I agree Ana, it is a team approach in responding to the surveys, and also a multi-step process to arrive at the number of patients you can enroll. I feel it is essential all stakeholders know where the enrollment projections came from, and this needs to be communicated by sites up front

I would add that the forms could be modified to ask - where did this number come from (EMR, past experience with similar study, best guess, etc).  
 
Likewise, sites should indicate, even in the absence of such a question where they derived their number from. This is a practice we have been doing at RxTrials for quite a long time - we want our partners to know with a greater degree of certainty the number we're giving is accurate and the math equation of taking 50% off (or whatever formula is used) is not necessary because we're already narrowed it down with accurate info. That said the next question still remains - out of all those potentials how many will go into the study - stay tuned case study underway! Have a great day - ckp 
 

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