Better Reporting of Clinical Trial Results

Standards for reporting

High profile cases recently in the news have made the public skeptical about clinical trial results reported by sponsors in the drug, biologicals, or medical device industries, especially when the data “have not been subjected to external, independent peer review…and is not integrated with other data or indexed.  Because academic researchers and their institutions often play a prominent role in such trials, these concerns challenge their integrity as well. “To strengthen the role of U.S. medical schools and teaching hospitals as trusted and reliable sources of research information, the Association of American Medical Colleges "(AAMC) announced new Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials.  For a list of these “comprehensive guidelines that would direct the ethical and operational aspects of data access, analysis, and reporting of clinical research studies,”⁽

“Researchers at academic medical centers should not be party to the release of misleading statements about trial results or to the suppression of outcomes unfavorable to a sponsor,” said (Association of American Medical Colleges) AAMC President Jordan J. Cohen, M.D. “Academic medical centers must honor the trust of the American public and scrupulously report their research results fully, credibly and accurately.”

“It is essential that the goals, specifications, and endpoints of clinical trials be registered and made public,” according to a statement made by the Consumers Union. “It is a scandal that in some recent cases only portions of clinical trials that made a drug look good were made public, and portions that revealed danger and unacceptable risk — or lack of effectiveness — were hidden.”

Hold public and patient interests above commercial interests

Many biopharmaceutical companies object to disclosing the current required level of trial data, saying it gives competitors too much information and jeopardizes their intellectual and commercial interests and rights. “Although protection of commercial interests is important, the social contract with trial participants must take precedence.”

“The current situation, in which clinical trials involving human subjects are conducted behind the veil of ‘proprietary interest’ and are subjected to the scrutiny of scientific review only at the will of their commercial sponsors, is unacceptable on ethical and scientific grounds. There must be a better balance between ensuring the commercial viability of ‘R & D’ and serving the best interests of patients and the public. The public registration of clinical trials is one way to rebalance the scales.”

The Ottawa Statement, endorsed throughout the international research community, “outlines fundamental principles for trial registration and how they can be operationalised.”  Recognizing that “public availability of information about all trials is essential to ensuring ethical and scientific integrity in medical research,” the Statement calls for sponsors to “disclose the protocol details of all trials up front, disclose amendments along the way, and post the results at the end.” Clinical trial participants “assume potential risks in order to contribute to knowledge; investigators and sponsors are thus ethically bound to make information about the study protocol and results publicly accessible.”  Not one drug company has endorsed this.

The World Health Organization (WHO) has launched an International Clinical Trials Registry Platform (ICTRP) project, “setting international norms and standards for trial registration and reporting.” It outlines 20 characteristics of the trial that need to be registered, omitting many of the “crucial items” in the Ottawa Statement on principles for trial registration.

Free, timely electronic access to trial protocols and research results

Trial registries give anyone, anywhere free electronic access to public repositories where information related to ongoing trials can be stored, searched, and accessed. In some cases, this includes the full text and data of published research.

The Public Library of Science (PLoS), “a non-profit organization of scientists and physicians committed to making scientific and medical literature a freely available public resource.”  Its new “international, peer-reviewed open-access journal,” PloS Clinical Trials, will “publish the results of randomized clinical trials in humans from all medical and public health disciplines.”  All published articles will be immediately and freely available online to read, download, redistribute, etc. PLoS Clinical Trials has no subscriptions or reprints to sell, making it beholden to no one.  Each trial report will be accompanied by an editorial summary of its strengths and weaknesses, including what it adds to current scientific knowledge. Readers will have the opportunity to post comments.