To lay bare the benefits and harms about medicines, researchers often need to get into the nitty-gritty details found in the data from the participants in clinical trials. Summary results often just don’t cut it. This week, AllTrials will be highlighting some of the research that demonstrates the benefits of these detailed analyses to make the case for providing researchers with greater access to trial data.
These analyses allow researchers to better judge the benefits of a treatment and to identify individuals who might respond better, or worse, to a specific treatment. But many barriers prevent researchers from reusing the contributions people have already made in clinical trials. Obtaining access to the original data requires substantial time and resources as researchers often have to directly contact trials sponsors. For example, it took researchers more than 2000 hours and 1000 emails to combine the various trial data for one review.
This is why patient groups, trial funders, researchers and some pharmaceutical companies support new protocols that will make it simpler to provide qualified researchers with access to anonymised individual patient data (IPD). For example, the European Medicines Agency is developing a policy on providing access to IPD from the trials it holds, and some pharmaceutical companies are beginning to grant access to data from their clinical trials.
Harlan Krumholz, director of the Yale Open Data Access (YODA) Project which provides access to data from pharmaceutical company Johnson & Johnson’s clinical trials, said:
We are hopeful that this initiative is the beginning of a new paradigm that can build trust, accelerate knowledge generation, and raise the level of science throughout the world. It should make it easier for people to participate in knowledge generation and foster an international community of scientists working for the public good. Our goal is to promote the constructive use of these data for scientific purposes — and we will not consider it a success unless there has been important new knowledge generated as a result.