Clinical Trial Data Disclosure: As EMA Pushes For Patient Level Info, What Control Will Firms Have?
Executive Summary
European Medicines Agency plans to require publication of all raw clinical trial data as of January 2014. While industry fears this policy will result in release of confidential commercial information, GSK is making patient-level data available to certain researchers.
You may also be interested in...
Vivli Nonprofit Hopes To Be One-Stop Shop For Clinical Trial Data
GlaxoSmithKline, Pfizer, and Biogen are among those participating in new data-sharing and analytics platform; 2,500 trials currently available to researchers.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.