Data Sharing Requirements and Evolution of the Publication Process

The theme for the 13th Annual Meeting of the International Society of Medical Publication Professionals (ISMPP), held May 1-3, 2017 was Global Publication Practices: Advancing Ethics & Scientific Integrity in the Era of Data Sharing. Given the evolving transparency requirements across regions and regulatory bodies, heightened demands for transparency and data sharing by journals and third parties (eg, All Trials), there couldn’t be a more important focus for medical publication professionals than timely and transparent sharing of data from clinical trials.

ISMPP and Awareness of Data Sharing Developments

ISMPP has provided education to our membership about the unfolding developments around data sharing for many years. ISMPP has sought out and invited experts and early thought leaders to present to our members during annual programs and educational events. These speakers and programs have served to help our profession examine and understand both the operational challenges of complying with new regulations and expectations, as well as perceiving the overall benefits of data sharing extended to a broad set of audiences.

Meeting the regulatory requirements of posting clinical trial results, including the provision of larger summary documents (eg, integrated safety or efficacy summaries) within the prescribed timeframe compels medical publication professionals to plan effectively for submission timelines. The availability of large collections of trial data will be indeed be helpful to many. However, this will not supplant the role of the peer-reviewed publication. In fact, the timely peer-reviewed publication of clinical trials will become even more important. Context for interpretation of the trial design, methods, data collection and results, is uniquely provided by the authors. Medical publication professionals have the responsibility and privilege to ensure publications are developed with process integrity, in collaboration with all authors, following GPP3¹ standards and ICMJE criteria for authorship.²

Needs and Opportunities

Many participants in the publication process have identified current challenges with publishing clinical trial results. This topic has been discussed often, notably by former British Medical Journal editor Richard Smith, who points out that there are many contributors, ranging across research funders, authors, journals, peer reviewers and publishers. Persisting challenges include that much research is never published, the time to publish is often very long, the complete data set is rarely shared or easily accessible, and papers that are published tend to report interesting or favorable results vs. negative or confirming outcomes.

So what can be done to promote transparency and data sharing of clinical trial results while addressing these challenges?

Several concepts aim to speed time to publication, and/or provide access to the underlying data supporting the results presented in the publication. These include the use of preprints, and developing a more “open” publication process.

Preprints could present an opportunity to speed the time to publish in the future. Preprints are manuscripts that have not yet been peer-reviewed, before they are uploaded to and released by a preprint server. If the publication is also published in a journal, it becomes the version of record, and tends to be cited more quickly. This approach has been successful in the fields of physics and mathematics. While preprints may change the way these researchers communicate early results, it is not clear if this truly speeds access to new findings. Because of needed corrections and revisions of preprints vs. the published version, and the media interest in clinical trial results, more experience is needed before preprints can be applied to biomedicine publishing.

A more tangible approach, is an open publication process. This process would require studies to meet specific criteria in order to be published, and data supporting the study be openly accessible. Review would be conducted by reviewers selected by authors, and performed at the time of publication for all to view. In addition, reviewers would be named, and authors would be able to comment on reviews and determine how and when to revise the study. All versions of the publication would be published and citable. This approach could address many of the challenges represented above, but could benefit from further input.

Alignment of ISMPP priorities and other like-minded partners/organizations

An important aspect of ISMPP’s mission is to advance the medical publication profession globally through enhancing integrity and transparency in medical publications. Our members continually invest in developing capabilities to improve standards and demonstrate results. Another important aspect of our mission is to collaborate with like-minded organizations to collectively advocate for needed evolution in the publication process, for the greater benefit of all participants and audiences. With this in mind, ISMPP has re-evaluated our common objectives and strengthened our outreach efforts to organizations such as COPE, ICMJE, and the Peer Review Congress, among others, to advance this conversation thoughtfully and more quickly.

Our goals in working with other organizations are to bring the best thinking forward: to publish transparent, effective publications in the same or earlier timeframes as regulator-required data sharing, and to enhance the interpretation and understanding of trial results by our audiences. As medical publication professionals, we have much experience and expertise to contribute, and together with others, can evolve medical publishing to a more open, transparent and credible process.

Juliana K. Clark, PharmD

Chair, ISMPP Board of Trustees (2017-2018)

Executive Director, Global Medical Writing, Global Medical Affairs, Amgen Inc.

The views expressed herein are those of the author and do not necessarily reflect those of Amgen Inc.