Clinical Trial Data Sharing – Worthwhile?

Submitted by GAtherton on 2 February 2015

Patients volunteer for clinical trials, most commonly because they hope to contribute to the understanding of their illness with the hope of bringing the prospect of better treatment a little closer. Those patients who do volunteer are sometimes seen as putting themselves at risk (albeit a very small risk) in the hope of helping research. A recent publication in the New England Journal of Medicine contends that research in turn owes those people a debt of gratitude – and perhaps more.

A clinical trial often proceeds to its conclusion, a researcher writes up their report and publishes one or two papers based on the work done with those patients, and then nothing more is done with the data provided by the patient. This could be data on 1000 people with a particular illness that took a long time to gather and could easily be useful to another researcher looking at the same or similar illness. However that new researcher must now raise funds to find another 1000 patients in order to measure very similar things. The authors of this paper suggest that that is a waste of time, money and the goodwill of the patients. We should be looking at ways to make all data in trials accessible to all researchers when that trial has finished.

This would involve a complete change of culture amongst researchers as traditionally data collected is kept secret, not least to protect the interests of the researcher should anyone else want to publish analyses of work carried out on their data. Currently no work can be published without the cooperation of the group that collected the data. In a new open system no cooperation would be necessary so safeguards would need to be in place that acknowledge the source of the data in published papers and other academic resources. Some groups might also be unwilling to release their hard earned data for nothing, some might be obliged to not release data by their funders and so on. This will not be a trivial change!

There are some who suggest that we have to be cautious so as not to risk disclosing the identity of some of the patients (though all data would be anonymised to prevent this), and researchers might risk malicious criticisms of their work, but overall the benefits to all comfortably outweigh the risks. 

Quoting the paper in NEJM:

Although there are technical hurdles, we need to change how we think about data. We need to view it as a community resource, much like a shared park, rather than as personal property. We need to recall every day that selfless volunteers put themselves at risk to advance medical science by enabling the data to be gathered. To honor that sacrifice, we need to turn those data into applicable knowledge; somebody else may well find something useful in your trial data that have been sitting idle for years. Let’s share and find out.