Image from "Honoring our promise: clinical trial data sharing"
at the NIH Director's blog.
“Drazen and Longo [the NEJM editors] are saying, essentially, that only the people who originally collect a data set can truly understand it, and anyone else who wants to take a look is a parasite.”
“A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data. The original investigators almost always intend to undertake additional analyses of the data and explore new hypotheses.”
- Exclusive use of the data for a minimum of 2 years after the first publication
- Another 6 months of exclusivity for every year the trial lasted, up to 5 years of exclusivity
- Anyone who wants the data should pay the original investigators “for their efforts and investments in the trial.”
“ `This is not working. I just hope that my death will not be in vain and someone learns from it so that others don't have to go through this’ was what my husband said when it became clear that the new drug combination was not working fast enough for us…. My husband died now more than 4 years ago. I have watched his and others' lives been plotted on curves at conferences like ASCO or EMSO and it is deeply upsetting that there are more than 280 researchers who are more concerned about their own careers than the lives of the patients on whom those careers are built. Claiming rights to data paid for with the lives of others has nothing to do with fairness.” Bettina Ryll, M.D., Ph.D., Melanoma Patient Network Europe