2/4/14 National Academies Book On Clinical Trial Data Sharing
The National Academies Press just published a book on sharing clinical trial data – a topic of interest to each of us in the Rhabdo community. The book is available for purchase as a paperback for $39.00 or as a free download in pdf format. You will need to sign up for a free NAP account at NAP.edu.
Once you’ve created a login, you can download the pdf version of the book at Here.
Guiding Principles, Elements, and Activities (2014)
Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, such data sharing—if carried out appropriately—could lead to improved clinical care and greater public trust in clinical research and health care. However, recommending strategies for how clinical trial data could be shared responsibly is a difficult process—many stakeholders have valid interests that sometimes are not aligned; different models and approaches have been proposed or tried; and proposing an approach that works for the wide range of clinical trials may be daunting. Undergirding any discussion of possibilities and needs
for clinical trial data sharing is a fundamental philosophical question: To whom ought the benefits of the data belong, and, accordingly, where lies the presumption as to whether data ought to be shared?