1 Boring Old Man

I hope I got across in the making of « wolf alert! wolf alert!… » part 1 that I think ClinicalTrials.gov is a good idea, and that putting it in the center of a system aiming towards appropriate Data Transparency is a good idea too, but that it needs some heavy tweaking before it will actually work. First, obviously, it needs to be used in a timely manner and that usage enforced. That part seems easy. No registration, no consideration for publication or regulatory approval. No Results posting, no consideration for publication or regulatory approval. No exceptions. Next, the a priori Protocol and Statistical Analysis Plan must be declared [in ClinicalTrials.gov] before the study starts and those results shown in the Results Database. If some investigator or sponsor wants to switch or add outcomes or methodologies in the published version, that’s their prerogative, but only if they also show us the results of their original plans. They can make their case in the paper, not behind closed doors. No exceptions.  At least that’s what I think. There are many opinions about whether the investigators should be held to their original choice of outcome variables and statistical methods. But there’s no controversy in my mind about secrecy. We need to hear what they thought a priori no matter what they decide after the study was underway or post hoc. No exceptions.

• DISCUSSION FRAMEWORK FOR CLINICAL TRIAL DATA SHARING: GUIDING PRINCIPLES, ELEMENTS, AND ACTIVITIES – January 2014
• Sharing Clinical Trial Data: MAXIMIZING BENEFITS, MINIMIZING RISK – January 2015

• Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors – January 2016

Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors

by Darren B. Taichman, Joyce Backus, Christopher Baethge, Howard Bauchner, Peter W. de Leeuw, Jeffrey M. Drazen, John Fletcher, Frank A. Frizelle, Trish Groves, Abraham Haileamlak, Astrid James, Christine Laine, Larry Peiperl, Anja Pinborg, Peush Sahni, Sinan Wu

PLOS. Published on January 20, 2016

[full text on-line]

Note: This editorial is being published simultaneously in Annals of Internal Medicine, British Medical Journal, Canadian Medical Association Journal, Chinese Medical Journal, Deutsches Ärzteblatt (German Medical Journal), Ethiopian Journal of Health Sciences, JAMA (Journal of the American Medical Association), Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal), New England Journal of Medicine, New Zealand Medical Journal, PLOS Medicine, Revista Médica de Chile, The Lancet, and Ugeskrift for Laeger (Danish Medical Journal).

… 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.

Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals.

The ICMJE also proposes to require that authors include a plan for data sharing as a component of clinical trial registration. This plan must include where the researchers will house the data and, if not in a public repository, the mechanism by which they will provide others access to the data, as well as other data-sharing plan elements outlined in the 2015 Institute of Medicine Report [e.g., whether data will be freely available to anyone upon request or only after application to and approval by a learned intermediary, whether a data use agreement will be required] [1]. ClinicalTrials.gov has added an element to its registration platform to collect data-sharing plans. We encourage other trial registries to similarly incorporate mechanisms for the registration of data-sharing plans. Trialists who want to publish in ICMJE member journals [or nonmember journals that choose to follow these recommendations] should choose a registry that includes a data-sharing plan element as a specified registry item or allows for its entry as a free-text statement in a miscellaneous registry field. As a condition of consideration for publication in our member journals, authors will be required to include a description of the data-sharing plan in the submitted manuscript. Authors may choose to share the deidentified IPD underlying the results presented in the article under less restrictive, but not more restrictive, conditions than were indicated in the registered data-sharing plan…

Data sharing is a shared responsibility. Editors of individual journals can help foster data sharing by changing the requirements of the manuscripts they will consider for publication in their journals. Funders and sponsors of clinical trials are in a position to support and ensure adherence to IPD sharing obligations. If journal editors become aware that IPD sharing obligations are not being met, they may choose to request additional information; to publish an expression of concern; to notify the sponsors, funders, or institutions; or in certain cases, to retract the publication…