Category Archives: Writing and Publishing

New NIH Collaboratory resource for the transparent reporting of PCTs

Cluster Randomized Trials, Data quality, Electronic health records, Research reporting standards, Research tools, Writing and Publishing, , , ,

The NIH Collaboratory has developed a tool to assist authors in the complete and transparent reporting of their pragmatic clinical trials (PCTs). In the PCT Reporting Template, users will find descriptions of reporting elements based on CONSORT guidance as well as on expertise from the NIH Collaboratory Demonstration Projects and Core working groups.

Particularly relevant to PCTs are recommendations on how to report the use of data from electronic health records. Other elements of importance to PCTs include reporting wider stakeholder engagement, monitoring for unanticipated changes in study arms, and specific approaches to human subjects protection. The template contains numerous links to online material in the Living Textbook, CONSORT, and the Pragmatic–Explanatory Continuum Indicator Summary tool known as PRECIS-2.

This resource is intended to assist authors in developing primary journal publications. It will be updated over time as new best practices emerge for the transparent reporting of PCTs.

Download the PCT Reporting Template.

Please note: this document opens as an Adobe PDF. If you do not have software that can open a PDF, click here to download a free version of Adobe Acrobat Reader.

This work was supported by a cooperative agreement (U54 AT007748) from the NIH Common Fund for the NIH Health Care Systems Research Collaboratory. The views presented in this document are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Originally published on September 1, 2016.

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Journal Editors Propose New Requirements for Data Sharing

Data sharing, Research reporting standards, Writing and Publishing,

On January 20, 2016, the International Committee of Medical Journal Editors (ICMJE) published an editorial in 14 major medical journals in which they propose that clinical researchers must agree to share the deidentified data set used to generate results (including tables, figures, and appendices or supplementary material) as a condition of publication in one of their member journals no later that six months after publication. By changing the requirements for manuscripts they will consider for publication, they aim to ensure reproducibility (independent confirmation of results), foster data sharing, and enhance transparency. To meet the new requirements, authors will need to include a plan for data sharing as a component of clinical trial registration that includes where the data will be stored and a mechanism for sharing the data.

Evolving Standards for Data Reporting and Sharing

As early as 2003, the National Institutes of Health published a data sharing policy for research funded through the agency, stipulating that “Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.” Under this policy, federally funded studies receiving over $500,000 per year were required to have a data sharing plan that describes how data will be shared, that shared data be available in a usable form for some extended period of time, and that the least restrictive method for sharing of research data is used.

In 2007, Congress enacted the Food and Drug Administration Amendments Act. Section 801 of the Act requires study sponsors to report certain kinds of clinical trial data within a specified interval to the ClinicalTrials.gov registry, where it is made available to the public. Importantly, this requirement applied to any study classified as an “applicable clinical trial” (typically, an interventional clinical trial), regardless of whether it was conducted with NIH or other federal funding or supported by industry or academic funding. However, recent academic and journalistic investigations have demonstrated that overall compliance with FDAAA requirements is relatively poor.

In 2015, the Institute of Medicine (now the National Academy of Medicine) published a report that advocates for responsible sharing of clinical trial data to strengthen the evidence base, allow for replication of findings, and enable additional analyses. In addition, these efforts are being complemented by ongoing initiatives aimed at widening access to clinical trial data and improving results reporting, including the Yale University Open Data Access project (YODA), the joint Duke Clinical Research Institute/Bristol-Myers Squibb Supporting Open Access to clinical trials data for Researchers initiative (SOAR), and the international AllTrials project.

Responses to the Draft ICMJE Policy

The ICMJE recommendations are appearing in the midst of a growing focus on issues relating to the integrity of clinical research, including reproducibility of results, transparent and timely reporting of trial results, and facilitating widespread data sharing, and the release of the draft policy is amplifying ongoing national and international conversations taking place on social media and in prominent journals. Although many researchers and patient advocates have hailed the policy as timely and needed, others have expressed concerns, including questions about implementation and possible unforeseen consequences.

The ICMJE is welcoming feedback from the public regarding the draft policy at www.icmje.org and will continue to collect comments through April 18, 2016.

Resources

Journal editors publish editorial in 14 major medical journals stipulating that clinical researchers must agree to share a deidentified data set: Sharing clinical trial data: A proposal from the International Committee of Medical Journal Editors (Annals of Internal Medicine version). January 20, 2016.

A New England Journal of Medicine editorial in which deputy editor Dan Longo and editor-in-chief Jeffrey Drazen discuss details of the ICJME proposal: Data sharing. January 21, 2016.

A follow-up editorial in the New England Journal of Medicine by Jeffrey Drazen: Data sharing and the Journal. January 25, 2016.

Editorial in the British Medical Journal: Researchers must share data to ensure publication in top journals. January 22, 2016.

Commentary in Nature from Stephan Lewandowsky and Dorothy Bishop: Research integrity: Don’t let transparency damage science. January 25, 2016.

National Public Radio interview on Morning Edition: Journal editors to researchers: Show everyone your clinical data with Harlan Krumholz. January 27, 2016.

Institute of Medicine (now the National Academy of Medicine) report advocating for responsible sharing of clinical trial data: Sharing clinical trial data: maximizing benefits, minimizing risk. National Academies Press, 2015.

Rethinking Clinical Trials Living Textbook Chapter, Acquiring and using electronic health record data, which describes the use of data collected in clinical practice for research and the complexities involved in sharing data. November 3, 2015.

NIH Health Care Systems Research Collaboratory data sharing policy. June 23, 2014.

Commentary from Richard Platt and Joakim Ramsberg in New England Journal of Medicine on challenges of data sharing from healthcare systems research. April 20, 2016.

List of International Committee of Medical Journal Editors (ICMJE) member journals.

PCORnet “Writing for Research” Webinars Available via Living Textbook

Guidance document, Research tools, Writing and Publishing, , ,

“Writing for the Clinical Research Setting, “A 4-part webinar series sponsored by the National Patient-Centered Clinical Research Network (PCORnet) is now available on Rethinking Clinical Trials. PCORnet Originally given in the fall of 2014 as part of the PCORnet “Office Hours” series, the recorded sessions are presented by Living Textbook managing editor Jonathan McCall, MS, and can be accessed as streaming video under the Tools for Research tab, or directly here.

The series provides a basic introduction to various facets of writing for the clinical research environment. Individual sessions, each roughly 1 hour in length, include the following topics:

  • Writing Peer-Reviewed Research Articles
  • Organizing and Writing Your White Paper
  • Writing Guidance Documents
  • Managing the Process of Writing and Publication