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BIO Comments Re: Comments on Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors

Dear Dr. Taichman:

The Biotechnology Innovation Organization (BIO) is pleased to offer the following comments on Sharing Clinical Trial Data: A proposal from the International Committee of Medical Journal Editors (“ICMJE”) (“the Proposal”). 1

BIO is the world's largest trade association representing 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.

General Comments

BIO member companies are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines. As such, we share the underlying goals of ICMJE in setting forth a policy to “increase confidence and trust in the conclusions drawn from clinical trials,” “enable the independent confirmation of results,” and “foster the development and testing of new hypotheses.”2 Even though most BIO member companies are small, prerevenue enterprises that operate with limited resources, and evaluation of requests for data may divert resources from their core mission of developing innovative therapies, BIO members recognize the value of supporting qualified external medical and scientific research via data sharing...