Professor of Neurology, Emeritus Mayo Clinic and Mayo Medical School
I am writing in response to the January Viewpoint column by Ivan Lieberburg, PhD, MD, Executive Vice President and Chief Scientific and Medical Officer of Elan Corporation based in Dublin (“Should Medical Journals Demand Stronger Guarantees of Independence of Authors? An Industrial Perspective,” page 4).
Dr. Lieberburg had responded to a policy by an international consortium of medical journals requiring principal authors of clinical trials to declare that they accept full responsibility for the conduct of the research and for the analyses and interpretation of the data. He defended the way his company conducts clinical trials but did not deny the need for disclosure of financial relationships and disclosure of potential bias involving authors.
Anyone who understands the process can list the sources of conflict of interest and potential bias in conducting an industry-sponsored clinical trial. It is imperative that editors who publish such trials require that the authors accept responsibility for understanding how the analyses were selected and carried out and how the results were interpreted. This does not preclude a person employed by the sponsoring companying being an author.
A clinical trial requires methodologists for the design, clinicians who know the disease process, and statisticians to select the appropriate analytic procedures and to conduct the analyses. It requires all of these specialists to help with the interpretation of the results. It is often desirable to have independent clinicians to adjudicate the end point events. It is usually required that there also be an independent data and safety monitoring board to monitor the recruitment of subjects and the conduct of the trial and to judge the effect of adverse effects as early as possible.
Pharmaceutical companies have access to all of these types of expertise either in the company or by contracting with persons or organizations outside the company. In spite of the many sources of potential bias, some companies have been quite successful in conducting clinical trials and have reported their results with appropriate candor, including negative studies. It is the conflicts of interest and the perceptions of bias that often color the results regardless of the integrity of the sponsoring company.
There must be a better way of doing some of these trials, particularly those that could have a major impact on a disease process. The National Institutes of Health (NIH) have plenty to do and not enough funds to do what is desirable. However, a partnership among qualified pharmaceutical companies, academic medical centers, and the NIH could form a consortium for drug trials in which there could be a peer review process for selection of priorities, with funding by the pharmaceutical company and participation by academic experts of the types previously noted.
Some NIH institutes have clinical trial units that already participate in clinical trials of drugs, devices, or procedures and could provide their expertise in such an enterprise. Some companies might believe that such an approach would compromise their competitive position. However, the perception or reality of integrity for a company would add greatly to their credibility and their ability to compete.