The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine’s (IOM’s) Committee on Strategies for Responsible Data Sharing (the Committee) for the opportunity to submit written testimony for Meeting One, scheduled for October 23, 2013.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
BIO and its member companies are committed to modernizing regulatory science and enhancing public health through advancements that fill knowledge gaps in drug development. To that end, BIO supports voluntary, responsible sharing of clinical trial data as one potential way to develop new knowledge or scientific insights. BIO member companies routinely publish clinical research results and collaborate with academic researchers, while both adhering to applicable privacy laws and regulations and protecting confidential commercial information.
Guiding BIO Principles on Clinical Trial Results Disclosure:
It is important to recognize that issues of transparency and disclosure of regulatory data are extremely complex and are currently being debated and evaluated globally in various venues. We urge the Committee to consider these issues in the context of other transparency initiatives, including the rulemaking process to expand the ClinicalTrials.gov database as directed by the Food and Drug Administration Amendments Act (FDAAA) enacted in 2007. As stated in BIO’s April 2009 testimony on the ClinicalTrials.gov expansion, it is critical to ensure that data to be interpreted outside of the regulatory review process have scientific merit and can enhance the treatment and safety of patients. Accordingly, the purpose of disclosure of such data, as well as appropriate recipients of such data, must be clearly and transparently identified.
In addition, it is important to strike a balance in achieving dual public health goals: the goal of enhancing scientific knowledge to advance public health and patient care, as well as the goal of protecting confidential and trade secret information, in order to maintain the incentives necessary for further investment in and development of new treatments for patients. With regard to the latter, the trade secret and commercially confidential nature of clinical data may remain even when such data are masked or pooled with data from other products.
BIO’s longstanding policies on clinical trial disclosure and results dissemination state that all confirmatory trials that evaluate both safety and efficacy in patients who have the disease or condition to be treated, diagnosed, or prevented should be registered in a comprehensive listing, readily accessible by the public, no later than 21 days post initiation of enrollment. Additionally, all confirmatory trials for marketed drugs, regardless of whether results are considered “positive” or “negative,” as well as all pivotal confirmatory clinical trials for a product that has been discontinued in development for all indications when such trials were terminated due to safety reasons, should have summary results posted in a clinical trials database one year after the completion of the analysis of trial results.