5 Questions: Michelle Mello On Ranking Clinical Trial Reporting Of Pharmaceutical Companies

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Publish Date:
December 7, 2017
Author(s):
  • Duff-Brown, Beth
Source:
Stanford Medicine News Center
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Summary

Pharmaceutical companies have come under fire in recent years for failing to meet standards for reporting the results of clinical trials, but a new analysis by the nonprofit organization Bioethics International indicates that some companies are improving.

On Dec. 5, Bioethics International published its second “Good Pharma Scorecard,” which found that companies are making “meaningful progress” on some metrics, in BMJ Open. The 2017 ranking evaluated clinical trial registration, results reporting, clinical study report synopsis sharing and journal article publication rates for new drugs approved by the Food and Drug Administration in 2014 that were sponsored by large drug companies. The FDA approved 19 novel new drugs sponsored by 11 large companies involving 553 trials that year.

Q: What are the main takeaways of this second scorecard?

Mello: We found that companies are taking their legal obligations around clinical trial reporting seriously. There is high compliance with the reporting requirements of the federal FDA Amendments Act. We also found there are some emerging industry leaders that are going further than the law requires in getting patients and doctors the information they need — and there are clear opportunities for other companies to do more.

The 2017 scorecard shows progress within the industry on some measures since the first scorecard was released in 2015. We found that the proportion of new drugs for which all phase-2 and -3 trials that supported a new drug application were disclosed went up from 50 percent in the 2015 rankings to 67 percent this time. We also found that the public availability of results for trials conducted in patients for each drug went up from a median of 87 percent to 96 percent, measured at 13 months post-FDA approval.

Q: Why is such a scorecard necessary?

Mello: Disclosing complete information about clinical trials is important because it gives doctors, prescription drug formulary managers and others the information they need to make the best decisions concerning prescriptions and insurance coverage. Historically, not all trial results have been reported, creating a selective view of the evidence base for a drug.

National Institutes of Health policy now requires making information about all clinical trials available, to alleviate public concerns about whether useful information is being hidden and speed up the decision-making based on safety signals. And disclosing information from phase-1 trials may help speed innovation and save money by preventing others from traveling down known, dead-end pathways or empowering them to design better trials based on the lessons learned from previous studies.

The scorecard is a way of reinforcing incentives for companies to provide this information. We conclude in our study, “Celebrating progress — and identifying where it is not occurring as quickly as it could — can move the field forward toward a shared vision of transparency and what it can achieve.”

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