New in Data Sharing for Clinical Trials

Data collected on patients treated in clinical trials to support approval of drugs and devices, was always considered to be confidential but with the introduction of policy 0070 from EMA, data will be shared from now to fuel future research and affirmation of current research. This is a mark of revolution in clinical research where industry is supporting this change. Big pharma giants are open to share data and looking forward for streamlined policies to implement it.

Recently, International Committee of Medical Journal Editors (ICMJE) have introduced a requirement for data sharing statements for clinical trials. Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in their member journals:

  • As of 1 July 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below.
  • Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial’s registration. The ICMJE’s policy regarding trial registration is explained at icmje .org/recommendations/browse/publishing-and-editorial -issues/clinical-trial-registration.html. If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript and updated in the registry record.

ICJME has set initial requirements for its member journals. Some ICJME journals already maintain these requirements and may also choose to have more stringent policy around data sharing.

Impact

  • This will enable independent reanalysis to re-confirm the observed results.
  • Historically, meta-analysis has been done using summary-level data, the number of meta-analyses of individual participant data has been growing substantially. Furthermore, meta-analyses done with individual patient data typically is more likely to detect treatment effects that differ across subgroups than meta-analyses done with aggregate data

Criticism

This step has been applauded for being introduced while few have criticized it as well. Many raised valid concerns that ICJME says that members are required to submit data-sharing statement in all submitted manuscripts but the committee has kept the door open for not sharing data by saying that editors “may” take into account ‘authors’ plans for data sharing when they’re deciding to publish a paper. Journal editors have not made it imperative to share data for publishing manuscripts and this may encourage reluctant researchers to do a right thing.

GCE’s belief

Although, GCE believes that this is a one step closer to vision to have a global research community where sharing de-identified data becomes norm. This iterative and incremental change will provide an opportunity to gain experience with data sharing in practice, and identify pitfalls and challenges to address before moving to more stringent requirements.

Link to ICMJE’s website: http://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf