Opening clinical trial data: are the voluntary data-sharing portals enough?

Abstract

Data generated by the numerous clinical trials conducted annually worldwide have the potential to be extremely beneficial to the scientific and patient communities. This potential is well recognized and efforts are being made to encourage the release of raw patient-level data from these trials to the public. The issue of sharing clinical trial data has recently gained attention, with many agreeing that this type of data should be made available for research in a timely manner. The availability of clinical trial data is most important for study reproducibility, meta-analyses, and improvement of study design. There is much discussion in the community over key data sharing issues, including the risks this practice holds. However, one aspect that remains to be adequately addressed is that of the accessibility, quality, and usability of the data being shared. Herein, experiences with the two current major platforms used to store and disseminate clinical trial data are described, discussing the issues encountered and suggesting possible solutions.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…U svijetu se svake godine provodi do 30 000 kliničkih ispitivanja, stvarajući golemi volumen neobrađenih podataka na razini pojedinačnog pacijenta 25 . Ipak, trenutačno postojeći portali za razmjenu podataka još nisu zadovoljavajući.…”

“…Ipak, trenutačno postojeći portali za razmjenu podataka još nisu zadovoljavajući. Kod većine je nužno predati zahtjev čija priprema oduzima mnogo vremena, a treba uključivati detaljan prijedlog istraživanja s ustrojem studije, glavnim završnim točkama i statistički plan 25 . Taj prijedlog zatim recenzira neovisno istraživačko vijeće koje odlučuje hoće li odobriti zahtjev za podatcima 21,25,26 .…”

“…Taj prijedlog zatim recenzira neovisno istraživačko vijeće koje odlučuje hoće li odobriti zahtjev za podatcima 21,25,26 . Trenutačno taj postupak traje predugo, a, kad podatci napokon i postanu dostupni, često nisu odmah spremni za uporabu 25 . S druge strane, uvođenje načina za olakšavanje prijenosa podataka od onih koji ih posjeduju do istraživača može biti nezgrapan i izazovan postupak.…”

“…Currently, however, available portals for data sharing are still not adequate. Most of them require a time consuming request, including a detailed research proposal with the study design, main endpoints and a statistical plan 25 . The submitted proposal is then reviewed by an independent research panel that decides whether to approve the request for data 21,25,26 .…”

“…The submitted proposal is then reviewed by an independent research panel that decides whether to approve the request for data 21,25,26 . Currently, this process takes too long and when eventually the data is obtained oftentimes it is not readily usable 25 . However, the means to facilitate data sharing from the data holder to the researcher may be cumbersome and challenging to implement.…”