Regulatory frameworks for clinical trial data sharing during the Pandemic and beyond: A scoping review (Preprint)

Abstract

Data sharing from clinical trials is well recognized and has widely gained recognition amid the COVID-19 pandemic. The competing interests of powerful stakeholders expressed through data exclusivity practices make clinical trial data sharing a complex phenomenon. The wider acceptance of data sharing practices in the absence of mandated policy creates uncertainty among trial investigators to count for risks vs benefit from sharing trial data. Data sharing becomes further complex as the trial data sharing is governed by the regional policies. This drew our attention to explore policies for informed data sharing.

This scoping review aimed to map the existing literature around the regulatory documents that guide trial investigators to share clinical trial data.

We followed a Joanna Briggs Institute scoping review approach and have reported the article according to the PRISMA extension for Scoping reviews (PRISMA-ScR). In addition to the use of the electronic databases, a targeted website search was performed to access relevant grey literature. The articles were screened at the title-abstract and the full text stages based on the selection criteria. All the included articles for data extraction were in English language. Data extraction was done independently using a pre-tested data extraction sheet. Included literature focused on clinical trial data sharing policies, guidelines, or SOPs. A narrative synthesis approach was used to summarize the findings.

This scoping review identified four articles and 13 policy documents from the grey literature. A majority of the clinical trial agencies require an agreement for data sharing between the data requestor/organization and trial agency. None of the policy documents mandates informed consent for data sharing. The time interval to share data underlying results, varies from six to 18 months from the time of trial publication. Depending upon trial data, policies follow both controlled and open access models. Regulatory documents identified in both scientific and grey literature emphasized on good research principles of protection of privacy of participant data and data anonymization through data sharing agreement between the data requester and trial agency. Need for an informed consent and cost of data sharing, timeline to share data, incentives, or reward to promote data sharing and capacity building for data sharing have remained grey areas in these policy documents.

This paper acknowledges the vital role of clinical data sharing from a public health perspective. We found that given the challenges around clinical trial data sharing, developing a feasible mechanism for data sharing is important. We suggest that standardizing data sharing processes by framing a concise policy with key elements of data sharing mechanisms could be easier to practice rather than a rigid and comprehensive data sharing policy.

This scoping review protocol has not been registered and published.