Wednesday AccrualNet Post (9-5-12): 5 great reasons to track screen failures: Not just bumps on the log
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.! Also, check out the coordinator-recommended screening log tools found here and tell us how they work for you.