UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns

Abstract

ObjectivesEvaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers.Study Design and SettingWeb-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)–registered CTUs.ResultsTwenty-three (51%) CTUs responded: Five (22%) of these had an established data sharing policy and eight (35%) specifically requested consent to use patient data beyond the scope of the original trial. Fifteen (65%) CTUs had received requests for data, and seven (30%) had made external requests for data in the previous 12 months. CTUs supported the need for increased data sharing activities although concerns were raised about patient identification, misuse of data, and financial burden. Custodianship of clinical trial data and requirements for a CTU to align its policy to their parent institutes were also raised. No CTUs supported the use of an open access model for data sharing.ConclusionThere is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…Data from trials should be responsibly used 28 . A recent survey from UK Clinical Trial Units disclosed some potential risks associated with data sharing 29 . These basically included a) misuse of data, b) incorrect secondary analyses, c) resource requirements and d) identification of…”

“…Podatcima iz kliničkih ispitivanja treba se odgovorno koristiti 28 . Nedavna anketa koju je proveo britanski UK Clinical Trial Units razotkrila je neke moguće rizike vezane za razmjenu podaka 29 . Ti su se rizici u osnovi sastojali od a) zloporabe podataka, b) netočnih sekundarnih analiza, c) količine potrebnih sredstava i d) identifikacije pacijenata 29, 30 .…”

Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…(28) A recent survey from UK Clinical Trial Units disclosed some potential risks associated with data sharing. (29) These basically included (a) misuse of data, (b) incorrect secondary analyses, (c) resource requirements and (d) identification of patients. (29,30) Researchers are responsible for presenting the data in a format amenable for external secondary use.…”

The International Committee of Medical Journal Editors proposal for sharing clinical trial data and the possible implications for the peer review process

“…Open and accessible data from a clinical trial may permit others to validate the findings, thereby increasing confidence in the results and importantly directing scarce resources to future work in the reproducible fields/areas that have clinical benefit. In fact, sharing data may be beneficial for all of science, not just clinical trials (2)(3)(4).…”

“…Notwithstanding this scenario, there are important practical aspects that will need to be addressed if the sharing of the IPD after the clinical trial publication becomes truly open and widely accessible as envisioned by the ICMJE. First, the survey findings of the United Kingdom publically funded Clinical Trials Units have highlighted significant concerns for sharing data including the misuse of data/incorrect secondary analysis, resource requirements/implications, loss of ability to publish, additional consent requirements, and identification of patients (3). Second, even in journals that require data to be shared at the time of publication, such as the PLOS journals (4), there can be wide variation and expectation of the actual data available when the article is published.…”