When it comes to reporting ongoing data updates in clinical trials, less is sometimes more, according to Lynn Meyer, CCRP, president of IntegReview IRB in Austin, Texas. “There’s a lot of wasted energy spent on over-reporting ongoing trial results,” she says. Unnecessary reporting to institutional review boards (IRBs) can cost an extra $5,000 per site, she adds.
Here is some case study math showing how the situation can get out of hand:
- Coordinator spends 5 minutes submitting the Investigational New Drug (IND) safety report to an IRB and 5 minutes to get the principal investigator’s signature and file everything in the Site File
- 10 minutes x 10 reports/month = 100 minutes, or about 1.5 hours per month
- One protocol = 2 IND safety reports per month
- 2 x $25 (report) = $50 per site
- If 100 sites: $5,000 per month
It’s a common and costly problem, Meyer says.
For example, some researchers automatically report a serious adverse event to their IRB. That’s the correct action to take if it is part of the trial protocol. However, there are no regulations actually requiring that information be sent to the IRB, Meyer says. “In many cases, the IRB will send back an acknowledgement of receipt and never look at it again,” she notes. Researchers can become prisoners, she says, of old standard operating procedures that fail to reflect new realities or what is actually required in a given situation.
It takes an experienced investigator to understand the nuances of the situation, Meyer says. While it is mandatory to report an unanticipated problem in a trial, inexperienced investigators sometimes feel that they are “safer” if they report on every little thing. “It’s a lack of confidence” as much as it is a true understanding of what’s required and what isn’t, Meyer explains.
There are tools out there to help. Meyer cites two Office for Human Research Protections (OHRP) guidances that offer checklists for how to determine if an event should be reported or not (see OHRP Guidance Decision Tree). It’s not always as simple as printing the OHRP checklist out and taping it over your computer screen, though.