News:Clinical Research Organizations (CROs), Academic Research Organizations (AROs), or Industry: Who’s best for clinical research

October 12, 2007 By Grendel Burrell [mailto:grendel.burrell@gmail.com]

Questions remain about the commercialization of clinical research and whether this is in the best interest of science or the public. The “Perspective” piece cites several examples over the past few years in which inadequate conditions, minimal oversight, and unlicensed or inadequately trained physicians have been uncovered in the clinical trial setting.

Approximately 5 years ago the five largest CROs formed the Association of Clinical Research Organization (ACRO, http://www.acrohealth.org/). The extent of regulatory authority over CROs is uncertain. The NEJM article refers to comments by the Office of Critical Path Programs at the Food and Drug Administration in which Rachel Behrman, Director, stated the CROs are accountable to the FDA. Behrman went on to state, “it’s not clear whether their accountability is through the sponsor or directly to us.” There are ongoing efforts through the agency to clarify such points. The NEJM article provides examples of CROs and conflicts with reporting issues to the study sponsors and to the FDA.

Dr. Shuchman writes that the emergence of CROs occurred in the early 1980s. Pharmaceutical companies have outsourced much of the work that used to be done “in house” for a variety of reasons. Companies and clinical trials have timelines and deliverables. The ability to meet these goals and milestones is critical to the pharma/device industry. The resources required to assemble an "in house" team to do a single trial may be prohibitive. Yet quality cannot be sacrificed for speed and economics.

“CRO employees are generally younger, less skilled, less experienced, and less educated than researchers in the pharmaceutical industry or academia,” writes Shuchman. The author also adds that CROs spend less on compensation and that the “lower salaries can result in turnover that can be as high as 100% during the lifespan of a single project (Azoulay P. Agents of Embededness. NBER working paper 10142.  December 2003.  Cambridge, MA: National Bureau of Economic Research (htt://www.nber.org/papers/w10142)).

Asked to comment on the NEJM article, Mr. Anton Mamin, Regional Director for Hesperion, in Russia, told WikiDoc, “For Central and Eastern Europe, 90% of CRAs are highly qualified MDs. It could be that they are younger, but this may be an advantage. They are willing to travel, and are motivated in terms of a career path.” Asked about the issue of turnover, Mr. Mamin replied that he was not aware of this situation but that,  “An issue is that there are too many small "one country" CROs that could in fact disappear after one project or be bought by bigger ones. Then 100% turnover is possible.”

An alternative to CROs, the academic research organization (ARO) is housed within a university and often uses faculty as clinical investigators, steering committee members, or executive committee members for a clinical trial. While publication rights for studies completed with a CRO often reside with the sponsoring company, when a trial is conducted by an ARO, the ARO and university want to ensure the right to publish the data. Shuchman states, “most AROs are considered less efficient than CROs.” Examples of conflicts between academic research groups and industry are provided.

Clearly the primary goals of research organizations must be to protect research participants, ensure the integrity of the data, and execute clinical trials to answer important scientific questions. Is one type of organization best suited to these goals? Some companies are now dividing the responsibilities between academic research organizations and CROs within a given clinical trial. This requires a strong organizational structure within the sponsor and excellent management of multiple groups to execute a clinical trial in a timely manner. Shuchman concludes the “Perspective” piece by stating that “the current flaws in the model will need to be remedied. This will require some shift in focus-less single minded attentions to ‘deliverables’ and ‘billable’ hours and greater concern with the discovery of new knowledge.”

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