5 Questions: Michelle Mello on ranking clinical trial reporting of pharmaceutical companies
A Stanford professor of law and of health policy discusses the ranking of large pharmaceutical companies based on their sharing of clinical trial information with the public.
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.
Two of 11 ranked companies — Johnson & Johnson and Sanofi — achieved the highest overall score for clinical trial transparency, both scoring 100 percent. AbbVie, Celgene, Merck, and Astra Zeneca all scored at or above the industry median.
Michelle Mello, JD, PhD, a Stanford professor of law and of medicine and a core faculty member at Stanford Health Policy, is a co-author of the report and a member of Bioethics International. She discussed the new findings with writer Beth Duff-Brown.
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.”
Q. The first scorecard showed that nearly half of all drugs reviewed by the FDA in 2012 had at least one phase-2 or -3 study that was not published, and only 20 percent of final trial results were posted on the ClinicalTrials.gov registry. What do you think helped spur the reporting improvements since then?
Mello: Companies’ reporting has been monitored and publicized pretty widely — by our scorecard and by the NIH, among others. Through our project, we learned about some of the barriers to complete, timely reporting; for example, sometimes one company acquires another and the transition causes delays. But we also saw high levels of engagement in the issue; most companies are trying to get things right. There’s still some disagreement, though, about the importance of reporting phase-1 trials, which are conducted in healthy participants rather than patients with an illness.
Q: Polls routinely show that most Americans believe pharmaceutical companies are more concerned with profit than people. Is greater transparency about clinical trials likely to improve this situation?
Mello: There are a number of issues that may have prompted this distrust — certainly, one issue that is very much in the spotlight at the moment is the high cost of prescription drugs. But much of this distrust dates to incidents many years ago in which it was discovered that companies incompletely reported clinical trial information, or in some cases distorted published analyses, and the drugs were later linked to safety problems. Following the old adage that sunlight is the best disinfectant, the transparency movement has been an effort to restore the public’s confidence that pharmaceutical companies can conduct and report clinical research responsibly.
Q. How does the scorecard process work?
Mello: For new drugs approved by the FDA in a given year that were sponsored by the largest 20 pharmaceutical companies, a team of researchers scours FDA documents, nearly 40 clinical trial registries and medical journal articles, and then they match up drugs, clinical trials and public reports. We conduct this analysis for each trial, then each drug and finally each company. We create a company ranking based on all the drugs each had approved that year. And we work independently of companies, but give them a chance to review our results and methods to make sure we haven’t missed anything.
Stanford Medicine integrates research, medical education and health care at its three institutions - Stanford University School of Medicine, Stanford Health Care (formerly Stanford Hospital & Clinics), and Lucile Packard Children's Hospital Stanford. For more information, please visit the Office of Communication & Public Affairs site at http://mednews.stanford.edu.