Be open about drug failures to speed up research

peter.suber's bookmarks 2018-11-16


"It can take 20 years or more to get a drug to market, from testing compounds in animals to running late-stage (phase III) clinical trials in thousands of subjects. More than 80% of drugs that are tested in humans fail to demonstrate safety and efficacy1 (see ‘High failure rate’); the rate for Alzheimer’s treatments is estimated at more than 99%2 (see ‘Alzheimer’s drug attrition’).

Yet the data behind these failures are generally not seen by regulators, or considered deeply by anyone outside the company sponsoring the trial. Without this information, learning is unlikely....

Initiatives for private companies to share biomedical data and ideas have expanded in the past decade. Some, such as the Biomarkers Consortium and the Structural Genomics Consortium, bring together many companies and academics to design experiments for the benefit of the community, such as identifying disease markers or characterizing tool compounds to understand how target proteins work. Others ask companies and academic groups to pool data in a common repository. For instance, the Project Data Sphere Initiative is a platform to share de-identified data from people who were enrolled in the control, placebo or even experimental arms of more than 180 cancer trials....

Information that is not shared is arguably the most important: data that failed to meet drug developers’ hopes are most likely to help progress. Large clinical trials are multimillion-dollar experiments to validate a hypothesis that an experimental drug will be effective and safe. Results that go against these expectations must be made available to refine hypotheses and to elaborate alternative ones.

Data from negative research can reveal whether a trial adequately tested the intended hypothesis. ..."


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Tags: oa.pharma oa.industry oa.medicine oa.repositories

Date tagged:

11/16/2018, 12:23

Date published:

11/16/2018, 07:23