Clinical trial transparency is high among large pharmaceutical companies, according to a new study, although there remains room for improvement in companies’ reporting of their data.
Clinical trial transparency is high among large pharmaceutical companies, according to a new study published in BMJ Open, although there remains room for improvement in companies’ reporting of their data.
The study, led by Jennifer E. Miller, PhD, of the division of medical ethics’ department of population health at the NYU School of Medicine, investigated transparency among pharmaceutical and biotechnology companies for their 2014 FDA-approved drugs.
Miller and colleagues used data from over 44 sources to analyze 505 clinical trials in 19 drugs (a median of 22 trials per new drug) and found that a median of 100% of trials in patients per drug were registered, a median of 71% reported results or provided a clinical study report (CSR) synopsis, and 80% were published. Ten of the drugs had at least 1 undisclosed trial in patients, however, and 6 (32%) had at least 1 undisclosed phase 2 or 3 trial; in total, 2864 patients participated in trials with undisclosed results.
When applying a standard that holds that all trials included in a successful New Drug Application (NDA) be made publicly available, transparency was lower. Overall, a median of 68% of trial results per drug were either reported, shared in a CSR, or published, and all 19 drugs assessed had at least 1 publicly unavailable trial that was conducted either in patients or in healthy volunteers. At least 7287 individuals participated in trials with undisclosed results.
A median of 25% of trials per drug were subject to mandatory disclosures under the Food and Drug Administration Amendments Act (FDAAA), and although all of these trials were registered on time, only 71% reported results on time. Of a total 110,426 individuals who took part in trials that were covered by the FDAAA, 66% participated in non-FDAAA compliant trials.
At 6 months after approval, many drugs had a low percentage of data made publicly available. For example, the drug Zydelig (idelalisib), approved for the treatment of some hematological malignancies, had made 19% of its trials and 48% of its participant data available. Similarly, the insomnia drug Belsomra (suvorexant) had made available only 27% and 24% of data (in the same respective categories) 6 months post-approval.
Based on the average of companies’ scores for transparency in trials conducted in patients and FDAAA compliance, the investigators gave drug makers overall transparency scores. The companies that ranked highest for overall transparency were the following:
Ranking below 90% were Novartis, Gilead, Allergan, and Valeant.
Overall, the authors wrote, analysis of publicly available information about clinical trials found high levels of transparency among large pharmaceutical companies for trials conducted in patients, but “The gap between transparency of results from the all-trials and trials-in-patients samples is striking.” The authors stated that making information about all trials available will be valuable in helping to allay public concerns about whether useful information has been kept from view, and could also help to facilitate decision making based on safety signals.
“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,” the authors concluded.
The study’s call for improved transparency mirrors the position of many major organizations; Devex reports that the World Health Organization and United Nations have both begun a push for the more timely sharing of results, especially in cases where a public health emergency is suspected. Public and philanthropic research funders have also begun to require trial outcomes to be made publicly available.