Molly E. Hoke, PhD, ISMPP CMPP™

Data transparency is a frequently mentioned and is a passionately discussed topic of relevance to, and has implications for, any publications professional working today in the world of clinical trial data generation and dissemination. Whether you work in academia, for the government, at an agency, or for a biotech or pharmaceutical company of any size, today’s rapidly evolving and highly visible environment has spurred us all to act with a greater sense of urgency regarding how we’re approaching data sharing.

Why Developing and Implementing a Data Transparency Policy Is Needed, and Sooner Rather Than Later

Specific asks with specific timelines. A June 2016 clinical trial data sharing proposal by the International Committee of Medical Journal Editors (ICMJE) was intended to further the goal of “helping to create an environment in which the sharing of deidentified individual participant data becomes the norm.” Subsequently, ICMJE issued an important editorial in June 2017, which stated:1

“Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals:

  1. 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.
  2. 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 www.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.”

Data sharing statements must have specifics on “what, where and how and for how long.” The editorial provided examples of what types of information should be indicated in data sharing statements.1

The second page of the editorial includes a table illustrating the specifics of what information should be shared and outlines four “levels” of data sharing statements that would fulfill the ICMJE data sharing statement requirements, from very open sharing (far left side of the table) to very restricted sharing (far right side of the table).

Lots of people are watching what is (and isn’t) being disclosed and when. Shortly after the June 2017 ICMJE editorial, a high-profile publication authored by Goldacre and colleagues presented the results of an audit study that examined 42 pharmaceutical “companies’ commitments on sharing summary results, clinical study reports (CSRs), individual patient data (IPD), and trial registration, for prospective and retrospective trials.”2  While the authors found companies’ commitments to data sharing were highly variable, they did feel the commitments were realistic (excluding journal submission for all trials within 12 months), as all elements of best practice were met by at least one company.2

This audit report was significant enough to warrant a “Rapid Response” in The BMJ authored by Al Weigel, President and Chief Executive Officer of the International Society for Medical Publication Professionals (ISMPP), with input from the ISMPP Board of Trustees.3,4  Specifically, it was noted that, 

“While variations were noted in the 42 company policies reviewed as part of the audit, it was constructive to find that a majority of the companies had policies that commit to the registration of all trials, availability of summary results, sharing of clinical study reports (CSRs), and availability of individual patient data (IPD) from clinical trials on request. In fact, over 90% of the top 23 pharmaceutical companies in the audit had policies that met all four of these transparency commitments.”

Moreover, numerous Data Transparency “watchdogs” have cropped up, including Good Pharma Scorecard (Bioethics International), TrialsTracker, (Evidence-Based Medicine DataLab), AllTrials Policy Assessment, STAT News, and WATCHER. The BMJ Opinion blog has a new series, “Unreported clinical trial of the week.”

Some Key Factors to Consider When Creating a Data Transparency Policy and Data Sharing Statement(s)

So hopefully if you weren’t already convinced, you are now convinced that your company needs to develop and implement a Data Transparency Policy, if it doesn’t already have one in place (including how to approach data sharing statements when submitting clinical trial results manuscripts to ICMJE journals as of July 1, 2018). It may seem like a daunting project to get started, but the reality is that it should be a fairly manageable task. Let’s review some key steps in the process and important resources to rely on.

Before getting started, assess the situation. Are the people you work with aware of current data sharing requirements and timing? Before getting started on the Data Transparency Policy development and implementation, it may be helpful to provide some education and training to colleagues and/or departments that may not be as familiar with the current data transparency landscape and need for inclusion of data sharing statements in manuscripts. So before diving in, be thoughtful about how you start the conversation regarding data sharing and the implications on publication planning.

Leadership team/sponsor buy-in and enthusiasm. It is recommended to have discussions, both early on and throughout the process, with the leadership team/executives/sponsors to get buy-in, guidance, and a clear understanding of expectations regarding the creation, implementation, and roll out of a Data Transparency Policy. Having clarity on various aspects will make the process more efficient for all involved. Discuss what levels of review of the policy should occur before going to the Leadership Team, who needs to review it after that, what approvals are needed, and expectations as to whether it will be posted publicly (and if so, if it should be a different version than the internal document).

Who should be part of the Data Transparency Policy team? This will vary depending on where you work; the Standard Operating Procedures, Policies, and Working Instructions already in place; and the current staffing and infrastructure, as well as the appetite for adding both if warranted by the team’s discussions. But to successfully develop, implement, and roll out a Data Transparency Policy, it will be imperative to pull in the right cross-functional team members at the right time from departments that should have a “voice” in the policy. Some team members and departments may be needed for all or a majority of the process, while some may be needed only for certain aspects. Table 1 below summarizes some key members to consider including in your Data Transparency Policy efforts. Other team members from key departments may need to be pulled in, such as Legal, Compliance, Medical Information, and Health Economics Outcomes Research/Real World Evidence.

Table 1. Potential Team Members/Departments to Consider Including When Developing, Implementing, and Rolling Out a Data Transparency Policy (Biotech/Pharma)

Internal

External

Clinical Development/Trial Leads Medical Affairs (Medical/Scientific Directors) Clinical Research Organizations
Statistics/Biometrics Regulatory Affairs Publications vendor(s)
Data Management Information Technology Data Sharing Platform vendor
Clinical Operations/
Medical or Clinical Writing
Corporate Training Anonymization/Redaction Platform vendor
Publications/Scientific (or Medical) Communications Corporate Communications Consultant with specific experience in instituting data transparency initiatives

Resources to Get You Started on Data Transparency Policy Development and Implementation

While the bad news may be that your company does not have a Data Transparency Policy or is not aligned on data sharing statements for manuscripts, the good news is that there are a lot of valuable resources readily accessible in the public domain on this important topic. These resources can serve as both educational and foundational materials, which, when collectively utilized by your Data Transparency team, will facilitate creation of a Data Transparency Policy that is custom-tailored to what makes sense for your particular situation. While this list is not meant to be exhaustive or endorse use of any particular company, resource(s), etc., it will hopefully illustrate the breadth and depth of high-quality data transparency resources at your disposal.

  • Many websites of major pharmaceutical companies have sections devoted to data transparency and have posted their data transparency policies, so they are publicly available, such as Amgen, Astellas, Bayer, Boehringer-Ingelheim, Eisai, GSK, Lilly, Merck, Novartis, Roche, Sanofi, Takeda, and UCB.
  • ICMJE (http://www.icmje.org/) provides:
    • Table on page 2 of the June 2017 editorial that can be used as a tool for discussion with your Data Transparency team to create your policy and data sharing statement
      • Have the team align row-by-row on each of the four columns (very open [far left column] to very restrictive [far right column] data sharing)1
    • Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (December 2017)
      • Includes Data Sharing Information and Table from the June 2017 editorial (pages 13-14)
    • List of journals that follow the ICMJE Recommendations
  • The audit study by Goldacre and colleagues contains a “Model pharmaceutical company clinical trial transparency policy” in Box 2 (page 9), which can be used as a basis for creating a Data Transparency Policy and as a tool for discussion and to gain alignment.2
    • It covers aspects of clinical trials that the company commits to, such as:
      • Registration
      • Summary methods
      • CSRs
      • IPD
  • Data-sharing platforms can be helpful to dive into early in creating a Data Transparency Policy, as they may help shape what should be included and/or key contributors or steps in the process. Some platforms include ClinicalStudyDataRequest.com (CSRD), Vivli, and The YODA (Yale University Open Data Access) Project.
  • ISMPP resources can be helpful and offer educational content via its Annual Meeting, European Meeting, ISMPP U webinars, and communications like this article in the official newsletter of ISMPP—The MAP. Recent examples of ISMPP U data transparency webinars are included in the Addendum at the end of this article.
  • Other organizations, like Drug Information Association (DIA), are devoted to keeping their membership up-to-date on changes in data transparency via specific “communities,” such as “Clinical Trial Disclosure (CTD),” and conferences, including the DIA’s Clinical Trial Disclosure and Data Transparency Conference and CBI’s annual conference on Clinical Data Disclosure and Transparency.

Bringing It All Together

The call for greater transparency in the disclosure of clinical trial results has increased in recent years, and promises benefits to patients, prescribers, and biotech/pharma alike. Therefore, companies must be proactive in deciding and articulating how they will approach data transparency. Publication professionals can play a key role in educating, providing resources, and leading (or being a significant member) of the team that develops, implements, and rolls out a Data Transparency Policy, including data sharing statement(s), at their companies.

With the ICMJE’s new requirements for data sharing statements in manuscripts becoming effective next month, it is important that publication professionals are prepared to effectively apply the requirements. A well-formed Data Transparency Policy will be invaluable in meeting this objective.

References

  1. Taichman DB, Sahni P, Pinborg A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors [published online ahead of print June 6, 2017]. Ann Intern Med. 2017;167(1):63-65. http://annals.org/aim/fullarticle/2630766
  2. Goldacre B, Lane S, Mahtani, et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study [published online ahead of print July 26, 2017]. BMJ. 2017;358: j3334. http://www.bmj.com/content/358/bmj.j3334
  3. Weigel A. RE: Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study [published online August 9, 2017]. BMJ 2017;358:j3334. https://www.bmj.com/content/358/bmj.j3334/rapid-responses.
  4. The BMJ Posts ISMPP Response to First Industry Analysis of Clinical Trial Transparency Policies. The MAP Newsletter website. August 11, 2017. http://ismpp-newsletter.com/2017/08/11/the-bmj-posts-ismpp-response-to-first-industry-analysis-of-clinical-trial-transparency-policies/. Accessed May 17, 2018.

Addendum. Recent ISMPP U Webinars on Data Transparency

  1. ISMPP U: Educational Series on Data & Financial Transparency: A Project of the ISMPP Global Transparency Committee (September 20, 2017)
  2. ISMPP U: Eighth International Congress on Peer Review and Scientific Publication Highlights (October 25, 2017)
  3. Asia Pacific ISMPP U: Demystifying Data Sharing in Scholarly Publishing? (November 15, 2017)

Note: ISMPP U recordings are available to ISMPP members only

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