The Center for Science in the Public Interest noted that “despite the value of disclosing CSRs, a year after its launch, the pilot project appears to have stalled. Only a single CSR has been posted on FDA’s website.”7 That was for apalutamide, indicated for the treatment of patients with nonmetastatic castration-resistant prostate cancer. Furthermore, the project only applies to approved products.
“It’s not very clear to what extent transparency actually hurts industry,” Hwang told Cancer Therapy Advisor. “For every company that may seek to limit transparency, there may be a counter party that wants more of it.”
Joshua Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and former FDA principal deputy commissioner, has written about the need for greater transparency by the FDA.8,6 “Appropriate redactions should be fine, but my understanding is that they also should be rare,” he told Cancer Therapy Advisor by email.
“Patient safety should always be the priority; I think that’s a major argument for greater transparency. By disclosing more about studies, future studies can be made safer,” said Dr Sharfstein.
An audit of clinical trial data availability for studies published between July 1 and December 31, 2015, found that only 15% of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial.9
“CSRs allow researchers to better estimate treatment effects and identify possible risks of harms that would not have been possible using the published literature or regulatory summaries alone,” Hwang said.
Many stakeholders would benefit from having more data see the light of day. Arguing against disclosing information to the very people who contribute to the data in the first place gets tricky, he said. Hwang is hopeful that Acting FDA Commissioner Norman (Ned) Sharpless, MD, who was the director of the National Cancer Institute, will not only continue the pilot program, but expand it.
Dr Sharfstein agreed it is important for the FDA to err on the side of more, not less, transparency. “Transparency is a long-term investment in innovation, public trust, and a successful agency.”
The EMA and Health Canada have helped to move the needle further and faster on transparency than we have in the US, so some drug information may already be available in the public domain, Hwang said. Researchers should not rule out the possibility that data are already available to them.
- Hwang TJ, Vokinger K, Sachs RE. Evaluating new rules on transparency in cancer research and drug development. JAMA Oncol. 2019;5(4):461-462.
- Landray M, Bax J, Alliot, L et al. Improving public health by improving clinical trial guidelines and their application. Eur Heart J. 2017;38(21):1632–1637.
- Yeoman G, Furlong P, Seres M, et al. Defining patient centricity with patients for patients and caregivers: a collaborative endeavor. BMJ Innov. 2017;3(2):76-83.
- Lurie P, Chahal H, Sigelman D, et al. Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study. BMJ. 2015; 350:h2758.
- US Food and Drug Administration. Clinical data summary pilot. https://www.fda.gov/drugs/developmentapprovalprocess/ucm589210.htm. Updated May 3, 2018. Accessed March 23, 2019.
- Sharfstein JM, Miller JD, Davis AL, et al. Blueprint for transparency at the U.S. Food and Drug Administration: recommendations to advance the development of safe and effective medical products. The Journal of Law, Medicine & Ethics. 2017;45(2_suppl):7–23.
- Center for Science in the Public Interest. An open letter in support of FDA’s clinical study report pilot project. Published January 16, 2019. Accessed March 23, 2019.
- Asamoah AK, Sharfstein JM. Transparency at the Food and Drug Administration. N Engl J Med. 2010;362:2341-2343.
- Hopkins AM, Rowland A, Sorich MJ. Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability. BMC Med. 2018;16:165.