Posted 05 December 2017
By Zachary Brennan
Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ.
Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014.
"On the drug level, about half of FDA-approved drugs have publicly disclosed results for all trials in patients who were included in our sample," the study found. "On the company level, about 18% of large companies fully disclosed all such results and complied with FDAAA [the Food and Drug Administration Amendments Act] disclosure requirements. Per drug, among trials in patients, a median of 100% of trials were registered and 96% had publicly available trial results, in some form."
Sanofi/Genzyme and Johnson & Johnson/Janssen achieved the highest overall clinical trial transparency scores, the researchers found, while AbbVie, Celgene, Merck and AstraZeneca also scored at or above the industry median. Valeant Pharmaceuticals and Allergan scored lowest on the scale.
"There is value in making information about all trials available," the researchers wrote. "NIH policy now requires it. Many companies already operate on this standard. It would alleviate public concerns about whether useful information is being hidden, and speed decision making based on safety signals. Additionally, disclosing phase I trials may help speed innovation and save money, particularly for small biotechnology companies, by preventing others from travelling down known dead-end pathways or empowering them to design better trials based on the lessons learnt from previous studies."
The study adds to research from November 2016, published in the New England Journal of Medicine, that found compliance with requirements on results reporting "has been low across many sectors of the clinical research enterprise."
Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies