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JAMA article addresses COIs in industry-sponsored clinical research

By David Schwartz
Published: May 9th, 2017

An article in the most recent issue of the Journal of the American Medical Association makes a series of recommendations for better addressing the potential for conflicts of interest in clinical trials sponsored by corporations. Those trials have had their share of bad publicity, and the authors — a Johnson & Johnson employed physicians and an Emory University physician — hope to address concerns over undue industry influence that can cloud clinical trial results.  

“It has long been recognized that the dual obligations companies have to both patients and shareholders create real and perceived conflicts of interest (COIs). If not properly managed, COIs can undermine physician and patient trust in industry-supported development of drugs and devices,” write authors Joanne Waldstreicher, MD, of J&J, and Emory’s Michael Johns, MD.

The management of COIs has improved dramatically in the last several decades, and particularly after a landmark 2009 report on COI by the Institute of Medicine, the assert. Other important initiatives include the Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials, recommendations from the Association of American Medical Colleges, and the Physician Payments Sunshine Act.

Despite those efforts problems persist, and “interpretation and publication of clinical trial results requires particular attention,” the authors state. Their recommendations include:

  • Careful justification of comparators (placebo or active) and doses
  • A well-documented statistical analysis plan, finalized prior to unblinding, with balanced, data-driven interpretation of results. The authors note that “many industry trials are double-blinded (investigators and participants) and even triple-blinded (investigators, participants, and sponsor), with strict attention to and documentation of any premature unblinding during the course of the trial.
  • Companies should use reviewers within the same company but independent from the R&D group conducting the trial to add rigor and objectivity. “Many companies are organized with a separate safety group that is independent of executives with commercial responsibility and, in some cases, even from the clinical trial research physicians and scientists,” they observe. In addition, the authors say, “many companies have internal independent health care compliance, audit, and quality assurance staff that audit and monitor for adherence to rules and regulations and work with business partners to remediate identified issues.”
  • Provide repeated and regular education of clinical faculty in their ethical responsibilities, and do the same for physicians and scientists working for pharmaceutical and medical device companies. “Consider creating a bioethics committee and collaborating with external ethics experts to respond to important bioethical issues that arise,” they add.
  • Involve “multiple stakeholders independent of the sponsor throughout the life cycle of clinical trials” to enhance objectivity. For large multicenter trials, consider an independent external steering committee responsible for “protocol design, ongoing conduct, and interpretation and publication of the results.”
  • Protect study subjects with an independent data and safety monitoring board, which can make recommendations on trial conduct and continuation based on the otherwise blinded safety and efficacy data.
  • Consider having data analysis handled by an external independent statistical group.
  • After publication and regulatory approval, establish a process for external researchers to request access to summary and participant-level clinical trial data so results can be independently verified.
  • In terms of outside review after the fact, the authors recommend, “to remove any real or suspected subjectivity in evaluation of requests for access to clinical trial data, an independent group may evaluate research proposals.” J&J has implemented just such a system through an agreement with the Yale Open Data Access (YODA) Project. “A key tenet of that arrangement was that research requests would be evaluated independently by the YODA Project and with full decision-making authority.”

The authors conclude: “there will always be potential COIs — financial and nonfinancial, conscious and unconscious. Continued identification and constructive efforts to work together to address these conflicts in a transparent and collaborative manner will enhance the collective ability of industry, biomedical researchers, and physicians to serve patients and develop new products and solutions that advance human health.”

Source: The JAMA Network

Posted under: Industry-Sponsored Research Week

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