Sekeres Calls for Contract Research Organization Reform
Dr. Sekeres offers concrete measures toward a repaired relationship between Contract Research Organizations and scientific investigators.
Mikkael Sekeres, MD, Vice Chair for Clinical Research at Cleveland Clinic Cancer Center and Editor-in-Chief of the American Society of Hematology (ASH) Clinical News magazine, recently wielded his editor’s pen in an editorial entitled “Contract Research Agonizations,” and a follow-up editorial with proposed solutions. His straight-from-the-gut, tough critique of contract research organizations (CROs) was borne of frustration with what he calls their “administrative kudzu,” and a desire to motivate change.
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Dr. Sekeres hit a nerve. The article received a rousing response from scores of medical professionals worldwide who have endured what he characterizes as the time- and soul-sucking indignities of one too many rote process, obscure portals and laborious site delegation logs declared mandatory by the CRO “troglodytes of trial torture.”
The response of Brad S. Kahl, MD, to the article took the form of his own editorial in Clinical Advances in Hematology & Oncology, entitled “Take Back the Research”. In it, he echoes Dr. Sekeres’ concern that the administrative inflation introduced in the name of “good practice” is beginning to kill clinical research. He calls for more room for judgment, for a focus on what makes sense to assure study integrity.
Dr. Sekeres’ editorial also received a letter of support from over 80 of the leading hematologists in Europe and has reverberated to the U.S. Food and Drug Administration and its European equivalent, the European Medicines Agency. Some CROs and pharmaceutical companies even took note, and in reaction to the editorial have revised their employee training and onboarding processes.
Dr. Sekeres recognizes the imperative of carefully monitoring therapeutic clinical trials, and that CROs help ensure trial protocol compliance. He calls them the “sultans of Serious Adverse Events” but laments that role’s accompanying overkill. Some examples of frustrations he expresses about a CRO site investigation visit (SIV):
Dr. Sekeres identifies high turnover, poorly trained emissaries, a perverse incentive structure and the absence of a common sense yardstick as nasty culprits in creating the “agony” of SIVs and subsequent interactions. He also argues that the rigidity and an aura of suspicion relay an institutional disrespect for the time, intelligence and integrity of investigators and study teams who are trying to explore novel therapeutics with integrity.
Dr. Sekeres attributes much of this to a lack of trust. He argues that litigation and regulation have instilled in serious professionals a fear of action and a reluctance to take personal responsibility, leading to processes that are not only dispiriting, but which he argues stymie medical progress.
To improve the tenor and effectiveness of the CRO/investigator relationship, Dr. Sekeres asserts that this assumption of trust should serve as the first rule. He suggests these specific steps:
To the study sponsor: be present at the SIV to validate its significance and provide continuity between shifting CRO associates. Keep ongoing communication lines open and collegial.
To the CRO:
At the close of Dr. Sekeres’ second editorial, he summarizes his plea to the CROs of this world in this way:
“All of our suggestions boil down to issues of trust and mutual respect. If you trust and respect us, we will provide you the information you need. And we will actually respect you a lot more.”