Disclosure of individual-patient data: time to put the patient first

The International Committee of Medical Journal Editors (ICMJE) is consulting on a proposal that authors reporting clinical trials in member journals will be required to share the underlying de-identified individual-patient data with others (Taichman et al., 2016). We believe that this proposal pays insufficient attention to the unique needs of the patients who take part in clinical research, on whose participation and trust medical progress depends.

While we agree with the general principles of transparency and data sharing as set out in the ICMJE proposal, we have concerns about the details. We make seven recommendations to maximize the societal benefits of data sharing while minimizing the risk to patients participating in research.

1. We believe that uncontrolled public access to individual-patient data is unethical, so the ICMJE should make it clear that data sharing needs to be restricted to research purposes only.
2. We believe that multiple analyses of individual-patient data have the potential to distort the evidence-base, so the ICMJE should insist on registration and disclosure of all analyses.
3. We believe that the patient perspective has been largely ignored, so the ICMJE should call for this perspective to be better studied and taken into account.
4. We believe that no method of de-identification is absolute and ‘future-proof’, so the ICMJE should make it clear that sharing of individual-patient data must be restricted to the minimum necessary.
5. We believe that current informed consent is inadequate, so the ICMJE should clarify what is required for genuinely informed consent.
6. We believe that patients deserve to have access to the data they help to generate, so ICMJE member journals should make a patient summary of results freely available.
7. We believe that both the benefits and risks of data sharing are poorly characterized, so the ICMJE should call on researchers to measure both intended and unintended consequences and review its policy accordingly.

Furthermore, we do not agree with the proposed deadline for data sharing of 6 months from publication. We believe that the ICMJE should set a timescale for responding to a request for individual-patient data rather than a timescale for data sharing per se.

Please see our full response at:

• https://www.pharmagenesis.com/wp-content/uploads/2016/04/Disclosure-of-individual-patient-data-time-to-put-the-patient-first.pdf.

A summary of our response along with other responses can be found at:

• http://icmje.org/news-and-editorials/sharing_clinical_trial_data_comments_feed.html (comment 6 at the top of page 2).

Reference

Taichman DB, Backus J, Baethge C et al. Sharing clinical trial data – a proposal from the International Committee of Medical Journal Editors. N Engl J Med 2016;374:384–6.