The desire (or rather proposal for a requirement) for data transparency was the focus of an editorial published today by the International Committee of Medical Journal Editors (ICMJE) in the Annals of Internal Medicine.
Editors from the New England Journal of Medicine, the Journal of the American Medical Assn., the Annals of Interal Medicine and the British Medical Journal, were some of the contributors in a proposal to motivated by ethical standards that would require researchers to share the data behind published studies generated by interventional clinical trials, which could potentially put patients at risk.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The editorial states:
As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the article’s findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements.
The ICMJE also proposes to require that authors include a plan for data sharing as a component of clinical trial registration. The organization is asking for feedback on the proposed requirements from anyone who is interested in sharing suggestions, which people can do at www.icmje.org by 18 April 2016.
Sharing data will increase confidence and trust in the conclusions drawn from clinical trials. It will enable the independent confirmation of results, an essential tenet of the scientific process. It will foster the development and testing of new hypotheses. Done well, sharing clinical trial data should also make progress more efficient by making the most of what may be learned from each trial and by avoiding unwarranted repetition. It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Read the entire proposal here.
