Clinical trial data sharing is increasingly viewed as important and an ethical obligation. To help facilitate and expedite the process of clinical data sharing, the International Committee of Medical Journal Editors (ICMJE) has proposed steps to encourage investigators to adopt such practices. They have published a proposal outlining the future requirements that will be needed if a clinical study is to be considered for publication by a member journal.
Under this proposal:
- ICMJE will expect authors to share the anonymised individual patient data (IPD) that was used to write the article within 6 months of publication. This would include all data identified in the results section as well as any supplementary information and metadata needed to replicate the findings. Such changes will need to be approved by the appropriate ethics committees and regulatory bodies as well as the study participants themselves and the ICMJE understands this cannot be implemented immediately. Therefore, the new requirements would need to be met by studies that start to enrol patients 1 year after the proposal has been adopted.
- ICMJE also want authors to describe how they intend to fulfil their data sharing obligation in their trial registration and this data sharing plan will need to be included in the manuscript. The plan must outline where the data will be stored and how access will be granted if not freely available to the public. Safeguards will be in place to ensure that the original investigators receive the appropriate recognition in any secondary analyses of the results and to guarantee traceability of the trial data.
The ICMJE see this proposal as a way to encourage study investigators to adhere to data sharing and ultimately improve the transparency and confidence of clinical trials. Read the proposal here. The proposal was published in 13 ICMJE member journals.
The ICMJE plans to adopt the scheme after due consideration of any feedback which can be given here by 18 April 2016.