The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public trust in the clinical trial enterprise. At the same time, the interests of all participating stakeholders must be carefully balanced while considering a pragmatic approach to enable increased access to clinical trial data.
Study participants themselves must have confidence that their personal medical information and privacy will be protected in accordance with the terms of their informed consent and in compliance with relevant laws and regulations. Additionally, in order for innovative biotechnology companies to successfully attract the investment necessary to fund a drug or biologic program over the decade or more required for its development, it is imperative that data not be disclosed prematurely or in a manner that does not protect confidential and proprietary information.
Most BIO member companies are small, pre-revenue enterprises that operate with limited resources. While data sharing activities may divert resources from their core mission of directly developing innovative therapies, BIO members recognize the value of supporting, to the extent possible, qualified external medical and scientific research. Toward this end, BIO recently adopted Principles on Clinical Trial Data Sharing, which outline considerations for member companies designed to increase data transparency and promote responsible sharing of clinical trial data.