Medical journal requirements for clinical trial data sharing: Ripe for improvement

“Summary points

Efficient sharing and reuse of data from clinical trials are critical in advancing medical knowledge and developing improved treatments.
We believe that the International Committee of Medical Journal Editors (ICMJE) clinical trial data sharing policy is currently inadequate.
Although data sharing plans help increase transparency, they do not ensure that data are shared, and they are often inadequately implemented.
We believe that the ICMJE should adapt a stronger policy on data sharing that is enforced rigorously in all ICMJE members and affiliated journals.
The policy should include a strong evaluation component to ensure that all clinical trial data are shared, their value maximized, and data producers incentivized….”

Prospective Clinical Trial Registration: A Prerequisite for Publishing Your Results | Radiology

“The ICMJE requires that clinical trial results be published in the same clinical trial depository where the trial is registered. These results are in the form of a short (?500 words) abstract or table (6,7). Full disclosure of the existing results publication in a clinical trial registry should be explicitly stated when the manuscript is submitted for publication. The Food and Drug Administration (FDA) has indicated it will enforce trial results reporting related to ClinicalTrials.gov (8). The FDA is authorized to seek civil monetary penalties from responsible parties, including additional civil monetary penalties. In the United States, the sponsor of an applicable clinical trial is considered the responsible party, unless or until the sponsor designates a qualified principal investigator as the responsible party. The FDA issued its first Notice of Noncompliance in April 2021 for failure to report results in ClinicalTrials.gov based on a lack of reporting the safety and effectiveness results for the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (8).

Finally, as of July 1, 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement. Clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial registration. (for further information, see www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html). Since most clinical trials take 2 or more years for results to be reported, the Radiology editorial board had expected such mandatory data sharing plans to be reported in the current year. However, because of the COVID-19 pandemic, many clinical trials were halted. Thus, journal publication requirements to include data sharing statements are more likely to impact authors beginning in 2023. Data sharing statements required for Radiological Society of North America (RSNA) journals may be found at https://pubs.rsna.org/page/policies#clinical.

In conclusion, prospective clinical trial registration is a mechanism allowing us to ensure transparency in clinical research conduct, honest and complete reporting of the clinical trial results, and minimization of selective result publications. Since its inception in 2004, this requirement has evolved into a policy that is practiced by major medical journals worldwide, is mandatory for publication of trial results, and, in some circumstances, is enforced by the FDA. Further, ICMJE journals, including RSNA journals, are expecting manuscripts that report trial results to include statements on data sharing. As each clinical trial design is unique, we encourage authors to refer to the full description of the current ICMJE policy at icmje.org for additional information pertaining to their specific circumstances.”

Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement | Medical Journals and Publishing | JAMA Network Open | JAMA Network

“Question  What are the rates of declared and actual sharing of clinical trial data after the medical journals’ implementation of the International Committee of Medical Journal Editors data sharing statement requirement?

Findings  In this cross-sectional study of 487 clinical trials published in JAMA, Lancet, and New England Journal of Medicine, 334 articles (68.6%) declared data sharing. Only 2 (0.6%) individual-participant data sets were actually deidentified and publicly available on a journal website, and among the 89 articles declaring that individual-participant data would be stored in secure repositories, data from only 17 articles were found in the respective repositories as of April 10, 2020.

Meaning  These findings suggest that there is a wide gap between declared and actual sharing of clinical trial data.”

Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations | BMJ Open

Abstract:  Objective To explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations.

Design A cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).

Setting ICMJE website; PubMed/Medline.

Eligibility criteria ICMJE-member journals and 489 ICMJE-affiliated journals that published an RCT in 2018, had an accessible online website and were not considered as predatory journals according to Beall’s list. One hundred RCTs for member journals and 100 RCTs for affiliated journals with a data-sharing policy, submitted after 1 July 2018.

Main outcome measures The primary outcome for the policies was the existence of a data-sharing policy (explicit data-sharing policy, no data-sharing policy, policy merely referring to ICMJE recommendations) as reported on the journal website, especially in the instructions for authors. For RCTs, our primary outcome was the intention to share individual participant data set out in the data-sharing statement.

Results Eight (out of 14; 57%) member journals had an explicit data-sharing policy on their website (three were more stringent than the ICMJE requirements, one was less demanding and four were compliant), five (35%) additional journals stated that they followed the ICMJE requirements, and one (8%) had no policy online. In RCTs published in these journals, there were data-sharing statements in 98 out of 100, with expressed intention to share individual patient data reaching 77 out of 100 (77%; 95% CI 67% to 85%). One hundred and forty-five (out of 489) ICMJE-affiliated journals (30%; 26% to 34%) had an explicit data-sharing policy on their website (11 were more stringent than the ICMJE requirements, 85 were less demanding and 49 were compliant) and 276 (56%; 52% to 61%) merely referred to the ICMJE requirements. In RCTs published in affiliated journals with an explicit data-sharing policy, data-sharing statements were rare (25%), and expressed intentions to share data were found in 22% (15% to 32%).

Conclusion The implementation of ICMJE data-sharing requirements in online journal policies was suboptimal for ICMJE-member journals and poor for ICMJE-affiliated journals. The implementation of the policy was good in member journals and of concern for affiliated journals. We suggest the conduct of continuous audits of medical journal data-sharing policies in the future.

Limited engagement with transparent and open science standards in the policies of pain journals: a cross-sectional evaluation | BMJ Evidence-Based Medicine

Abstract:  Scientific progress requires transparency and openness. The ability to critique, replicate and implement scientific findings depends on the transparency of the study design and methods, and the open availability of study materials, data and code. Journals are key stakeholders in supporting transparency and openness. This study aimed to evaluate 10 highest ranked pain journals’ authorship policies with respect to their support for transparent and open research practices. Two independent authors evaluated the journal policies (as at 27 May 2019) using three tools: the self-developed Transparency and Openness Evaluation Tool, the Centre for Open Science (COS) Transparency Factor and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosure of conflicts of interest. We found that the journal policies had an overall low level of engagement with research transparency and openness standards. The median COS Transparency Factor score was 3.5 (IQR 2.8) of 29 possible points, and only 7 of 10 journals’ stated requirements for disclosure of conflicts of interest aligned fully with the ICMJE recommendations. Improved transparency and openness of pain research has the potential to benefit all that are involved in generating and using research findings. Journal policies that endorse and facilitate transparent and open research practices will ultimately improve the evidence base that informs the care provided for people with pain.

 

Abstract: Potential predatory journals are colonizing the ICMJE recommendations list of followers

Abstract:  

BACKGROUND:

The International Committee of Medical Journal Editors (ICMJE) has expressed its concerns about predatory journals using the list of ICMJE Recommendations (ICMJE-R) followers to “gain the appearance of legitimacy.” We assessed the presence of potential predatory journals on the ICMJE-R list and their adherence to ICMJE recommendations.

METHODS:

A random sample of 350 journals from the estimated 3,100-3,200 biomedical journals listed as ICMJE-R followers was chosen. Data collected from the ICMJE and journal webpages in English were: adherence to six ICMJE-R policies/requirements, year of journal’s listing as ICMJE-R follower, discipline covered, publisher and its country of origin and existence of article processing charge. Potential predatory journal was considered as one open access journal not being a member of a recognized listing in COPE, DOAJ, OASPA, AJOL and/or INASP.

RESULTS:

Thirty-one percent of journals were considered to be potentially predatory; 94% of them were included in the ICMJE-R list in 2014-2018. Half were published in the United States and 62% were devoted to medicine. Adherence to five of the six policies/requirements was infrequent, ranging from 51% (plagiarism) to 7% (trial registration). Seventy-two percent of journals mentioned a policy on authors’ conflicts of interest. Information on article processing charge was available for 76% journals and could not be found for 22%. Authorship policy/ instructions were significantly more present in journals with publishers from India than from the USA (53% vs 30%; p = 0.047), with no differences in the other five policies.

CONCLUSION:

Predatory journals should be deleted from the ICMJE-R list of followers to prevent misleading authors. ICMJE-R following journals need to be reevaluated with pre-defined published criteria.