Nearly 85% of clinical research associates (CRAs) were fraudulently documenting informed consent during a Phase III trial involving more than 100 sites, according to an observational study of several clinical trials conducted by Laura LaRosa, RN, MS, president of Sheldon Clinical Trials Consulting, Inc.
“I think [some form of clinical operations documentation fraud] is happening at every single drug company and at every clinical research organization (CRO),” LaRosa says.
Her observations are based on her review—conducted over 18 months—of two global CROs, two project managers, four clinical team leaders, and 18 CRAs. In addition, she has conducted a review for a separate sponsor of a trial with a focus on a clinical team leader and two CRAs.
LaRosa is also informed by her years as an investigative compliance consultant. “Seeing these issues over 21 years of clinical research experience is what made me start to record the data,” she says.
While many of the errors can be chalked up to relatively innocent mistakes, LaRosa has encountered chilling situations where there was clearly premeditation. “I had one case where a CRA with 20 years of experience was doing her job properly in the field, only to have an in-house CRA with four years of experience try to make her change reports to fit the study protocol.” The experienced CRA finally refused to sign the report.
In another case, what LaRosa first took as innocent errors proved to be far worse. “It became clear that if there had been any kind of review, these mistakes would have been identified and corrected,” she says. An example: an enrolled subject was counted twice by slightly changing the spelling in their name. In another case, CRAs were consistently backdating, then often misfiling, interim visit follow-up letters.
Errors of both kinds are probably generated by time pressures, internal political pressure to keep a study moving, and a lack of education and training. LaRosa applauds recent ACRP initiatives aimed at defining and delineating monitoring competencies, opening up new avenues to certification, planning for a new entry-level assessment of clinical research knowledge, and laying the groundwork for competency frameworks for further clinical research roles. “I think what ACRP is doing is spot on,” she says.
Flawed hiring procedures are also having a negative ripple effect, LaRosa speculates. For example, candidates appear for an interview with an excellent resume, but “can’t answer basic questions when you drill down.”
By some measures, resume fraud is rampant in the clinical trial hiring arena. “With more than 40,000 individuals in our database holding a CRA title, we have found that approximately 17% of them have falsified all or part of their resumes,” says Angela Roberts, head of CRA recruitment at CRAresources.
Standardized training and certification can help reverse the trend, LaRosa and other industry experts suggest.
Author: Michael Causey