Study Issues

Wednesday AccrualNet Post (9-5-12): 5 great reasons to track screen failures: Not just bumps on the log

Last Updated: Sep 13, 2012

Originally posted by: Ellen Richmond, AccrualNet Co-Moderator, on the former AccrualNet site on September 6, 2012.

 

We all know that, unfortunately, completing clinical trial accrual often takes more than a year. However, the flip side of the coin is that over time, an ineligible patient may become eligible. A well-maintained screening log (that tracks screening dates, contact info, reasons for not participating, etc.) makes it easy to know which patients you might re-screen for eligibility and when to re-screen them. Study coordinators have shared the following six different successful re-screen scenarios that they found by reviewing their logs:

 

1. The protocol required “no history of cancer in the past five years”. A patient who was 4 years past prior cancer diagnosis at first screening qualified for the study a year later.

 

2. A patient was excluded because of a disqualifying “active skin infection”.  He became eligible and signed consent after his infection resolved within 2 months.

 

3. A patient’s lab value was  just slightly outside of the required range but upon repeat at the next clinic visit, the result was normal.

 

4. A protocol was amended to broaden eligibility criteria by allowing use of a common concomittant medication.  Several previously ineligible patients were found on the screening log.

 

5. A patient chose not  to participate in a study because of extra clinic visits. She re-considered when the coordinator called her months later after the study was amended to limit the number of required procedures.

 

Let us know if you have had successful re-screening experiences or if you are able to apply any of the above scenarios to your practice! 

 

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