AMA Calls for Gov't Registry of All U.S. Clinical Trials

Many states and communities across the country want to be leaders in the much anticipated bio-based economic boom. Even more companies are hoping to create the next great multi-billion-dollar pill. For a few firms, that push for profits may be too great, replacing the original focus on human health or environmental issues.

Last week, in response to concerns about the impact of pharmaceutical industry sponsorship on research outcome, quality and publication bias, the American Medical Association (AMA) House of Delegates called for the Department of Health and Human Services to establish a comprehensive registry for all clinical trials conducted in the U.S.

The new registry would ensure that trials with negative as well as positive results are publicly available, by providing every clinical trial with a unique identification and ensuring publication or placement on an electronic database of all results from registered trials.

The new policy, approved at the AMA’s annual meeting, also calls for the AMA to urge institutional review boards (at hospitals, universities and medical centers) that must approve any research involving human subjects to consider registration of clinical trials as a condition for approval.

“Studies with positive findings are more likely to be published than studies with negative or null results,” said AMA Trustee Dr. Joseph Heyman. “We are concerned that this pattern of publication distorts the medical literature, affecting the validity and findings of systematic reviews, the decisions of funding agencies and, ultimately, the best practice of medicine.”

The AMA cited growing concern about the influence commercial support of drug trials may have on this publication bias. There are potential problems arising from clinical trial agreements that may delay publication or delete information from publications. There may be outcome bias resulting from the use of unreliable methods and inadequate sample size or comparison groups. Industry-funded studies may be more likely to use placebos or inactive controls, increasing the likelihood of achieving positive study results.

In studying this issue, the AMA also found direct sources of publication bias. Investigators and authors are reluctant to submit studies unless the results are positive or significant, believing that journals will not publish them. Journals are more interested in publishing studies that are likely to affect clinical practice. As a result, confirmatory trials, trials with negative results, and trials that show no significant result are less likely to be published.

The new policies were based on recommendations put forth in a report from the AMA’s Council on Scientific Affairs (CSA). Authors of the study reviewed the available scientific literature on the relationship between pharmaceutical sponsorship and research outcome, quality or publication bias, including 12 systematic reviews of thousands of original studies.

Biotech Ethics and TBED

The race for biotech leadership - in agriculture and the life sciences - has elevated questions of ethics, morality and civic responsibility within the technology-based economic development (TBED) community. As recent scientific and technological advances have greatly expanded man's influence over nature and creation, many people are raising concerns about the moral limits of our progress, the environmental implications of our actions, and the need to include societal costs and obligations in defining biotech success.

Are there any "ought nots" to guide state and local investments for creating knowledge-based economic growth? If so, what are they? What role should or does ethics play in TBED? Conversely, what moral social responsibilities do the economic development, business and scientific communities have inherently, if any?

Ethics and TBED will be just one of the 25-plus thought-provoking breakout sessions at Building Tech-based Economies: Preparing for Tomorrow's Challenges, to be held in Philadelphia on October 14-15. More information on SSTI's 8th annual conference is available at: http://www.ssti.org/conference04.htm [expired]