In January of this year, the International Committee of Medical Journal Editors (ICMJE) outlined a proposal to share non-personalised data from clinical trials within 6 months of the publication of primary results. This month, an article published in the New England Journal of Medicine has revealed that researchers are not fully supportive of this initiative. The International Consortium of Investigators for Fairness in Trial Data Sharing, along with the backing of nearly 300 researchers from over 30 countries, has expressed dissatisfaction with the proposal and declared that a more in-depth investigation of the benefits, risks and costs is needed.
A key area of concern is the short time period (6 months) that was suggested between publication and data sharing. Many investigators plan to use trial data to publish additional articles to the primary report. Fast data sharing could affect these secondary manuscripts and discourage investigators from getting involved with large clinical trials. Alternatively, researchers may delay the publication of the primary trial data to give time for the preparation of these secondary articles, which would impede the publication of clinical results in a timely manner. The authors propose 2–5 years as a more realistic timeframe for data sharing, depending on the size of the trial. The authors also outline the challenges of data sharing. The process needs careful, controlled management to ensure that all data requests are dealt with fairly and that any further analyses are performed correctly and do not weaken the original results erroneously. The involvement of independent statistical reviews of all secondary data analyses could safeguard against inaccurate reports. Finally, the authors suggest that there should be some sort of financial recompense for sharing data, to allow the original investigators to recover some of the costs of conducting the trial and making the data available.
It seems that more consultation on the process of data sharing is needed to bring publishers and researchers together.