Smaller Biopharmas Lagging Behind Big Firms in Trial Transparency, Study Finds
The latest study to look at biopharma sponsors’ trial transparency performance shows that while several big-name companies are meeting their obligations to share trial results with other researchers and the public, smaller firms are struggling.
The study of 42 companies that had novel drugs or biologics approved by the FDA in 2016 or 2017 assessed their clinical trial transparency based on trial registration and reporting of results in such publicly available databases as ClinicalTrials.gov (CT.gov), publication of results in professional journals and efforts to share results with trial participants.
The analysis, conducted by researchers at Yale, Stanford and the University of Pennsylvania and published in the BMJ this month, found that AbbVie, Amgen, Bayer, Merck KGaA/EMD Serono, Novartis, Roche/Genentech and Takeda were all 100 percent transparent, with Novo Nordisk, Sanofi, Shire and Merck (U.S. and Canada) nearing full transparency.
But the overall findings were troubling. Only 58 percent of companies studied had results publicly available for all their trials and only 42 percent were fully compliant with CT.gov reporting requirements. A mere 26 percent of companies met all of the researchers’ transparency criteria.
The researchers concluded that large biopharma companies had a much greater degree of clinical trial transparency than their smaller counterparts due to superior data-sharing procedures and CT.gov compliance.
“Greater research transparency is needed, particularly among nonlarge companies, to maximize the benefits of research for patient care and scientific innovation,” the researchers concluded. “Clinical trial transparency, including trial registration, results dissemination and even data-sharing, is becoming the norm in research, with clear benefits for patient care and drug and vaccine development.”
Read the full study here: https://bit.ly/3wTqXJ3.