Pharmaceutical Companies Under Pressure To Publish Negative Trial Results

| September 11, 2013

Mainstream medicine enjoys a powerful and privileged position as one of the bedrock sciences on which our whole society depends.

The British Pharmacological Society (BPS) and the American Society for Pharmacology and Experimental Therapeutics (ASPET), have stepped forward in support of the growing pressure being put on pharmaceutical companies to publish the negative findings from early clinical trials—dating as far back as 2000.

In their jointly published journal, Pharmacology Research & Perspectives, the BPS and ASPET are launching a platform for researchers to publish negative findings in two important areas: preclinical papers that show a premise to be incorrect, and research on drugs that have failed in early clinical development. This initiative can inform future researchers whether further drug development is warranted.

Professor Phil Routledge, BPS President, said: “It is ethically correct for pharmacologists working in academia, industry and the health services to publish negative findings. Openness not only ensures that the research community is collectively making the best possible use of resources, but also that clinical trial volunteers are not unnecessarily exposed to likely ineffective or potentially unsafe treatments when evidence may already suggest that the drug target in question is flawed.”

Both BPS and ASPET are committed to the view that new opportunities for publishing negative findings are needed, in order to avoid unnecessary duplication of research and waste of resources.

It has been well-documented that it is difficult for authors to find journals prepared to publish negative findings. In addition, once a trial shows negative results, resources within an organization may be reallocated so there may not be the opportunity to produce and submit a scientific paper subsequently.

Dr Mike Curtis, BPS Fellow and Editor-in-Chief of Pharmacology Research & Perspectives, said that as a research author he has found that historically, negative findings have tended to remain unpublished and that journal editors often rejected research on the grounds that the findings were negative.

Dr James Barrett, Chair of ASPET’s Board of Publications Trustees, added that the failure to publish preclinical and clinical findings that are negative is doing the pharmaceutical and research industry a lot of harm. He also said that if such studies are based on appropriate methodology and conducted well, they can add valuable information that can provide a positive direction and momentum to both basic and clinical research.

Campaign For Safer Medicine


Sources:

Hayes A, Hunter J. Why is publication of negative clinical trial data important? Brit J Pharmacol.2010;167: 1395–7.

Sterne JAC, Eggers M, Moher D. Addressing reporting biases. Cochrane Handbook for Systematic Reviews of Interventions.

Print Friendly

Tags: , ,

Category: Latest News

Comments are closed.