J&J, Sanofi ranked best for clinical trial transparency
- Among the big drug companies that received Food and Drug Administration approvals in 2014, Johnson & Johnson and Sanofi SA were the best at registering clinical trials for their new medicines as well as reporting, sharing and publishing results from those investigations, according to a new study.
- J&J and Sanofi fetched perfect 100% transparency rates on Bioethics International Inc.'s latest Good Pharma Scorecard. AbbVie Inc., Celgene Corp. and Merck & Co. rounded out the top five most transparent drugmakers with scores of 96%, 95% and 93%, respectively, while Valeant Pharmaceuticals Inc. was at the bottom with a 50% transparency rate.
- Bioethics' evaluated 11 large pharmas and biotechs. Collectively, the companies secured approval for 19 new molecular entities — either as solo treatments or in combination therapies — and conducted more than 550 clinical trials for the innovative drugs.
The march toward greater clinical trial transparency has picked up considerably in recent years, in no small part due to healthcare regulators. The World Health Organization, for instance, called for universal clinical trial transparency back in 2015, arguing that withholding data increases financial costs and risks to patient lives. The National Institutes of Health has also pushed for greater transparency, issuing a final rule last year threatening to levy civil penalties or cut off funding to any pharmaceutical investigator or sponsor that didn't register their studies on Clinicaltrials.gov.
There are now about 90 websites like Clinicaltrials.gov across the globe that serve as pharmaceutical registries — housing a wide variety of abstracts, protocols and data on drugs in development. They have also become critical tools for patients looking to participate in a clinical trial.
Some drugmakers, however, are better at posting on those sites and disseminating clinical trial data, according to Bioethics.
In its study, the firm looked at the top 20 largest biotechs and pharmas and narrowed the focus on just the 11 that received an FDA thumbs up in 2014 for a new molecular entity. Bioethics then gave the companies transparency rates based on several criteria, such as whether they put the clinical trials for those new medicines on a public registry or published data in a journal indexed in PubMed, Google Scholar or EMBASE within 13 months after the FDA approval.
After crunching the numbers, the Good Pharma Scorecard looked like this
- #1 Johnson & Johnson (100%)
- #1 Sanofi SA (100%)
- #3 AbbVie Inc. (96%)
- #4 Celgene Corp. (95%)
- #5 Merck & Co. (93%)
- #6 AstraZeneca plc (91%)
- #7 Roche AG/Genentech (90%)
- #8 Novartis AG (88%)
- #9 Gilead Sciences Inc. (73%)
- #10 Allergan plc (63%)
- #11 Valeant Pharmaceuticals Inc. (50%)
"The study highlights that companies are taking their legal obligations around clinical trial reporting seriously," said Michelle Mello, a professor at the Department of Health Research and Policy at Stanford University School of Medicine and a co-author on the paper. "We also found there are some emerging industry leaders that are going farther than the law requires in getting patients and doctors the information they need—and there are clear opportunities for other companies to do more."
Bioethics released another scorecard in 2015. In just two years time, drug manufacturers have demonstrated a noticeable improvement in their clinical trial transparency efforts, according to the firm. Between the 2015 and 2017 scorecards, the crop of new medicines with all the Phase 2 or Phase 3 trials from their New Drug Applications disclosed rose from 50% to 67%. Drugmakers also did better at releasing trial in patient results within three months following FDA approval, and at making more data available to the public.
A quick search on ClinicalTrials.gov for Johnson & Johnson or its drug development arm Janssen Pharmaceuticals Inc. will yield roughly 2,700 hundreds results where either is listed as a study sponsor. Sanofi, meanwhile, comes up as at least a co-sponsor for more than 2,500 investigations.
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