Abstract
BackgroundThe sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is not the norm, but the unprecedented pandemic caused by SARS-CoV-2 may serve as an impetus for greater data sharing. We sought to assess the data sharing intentions of interventional COVID-19 trials as declared in trial registrations and publications.MethodsWe searched ClinicalTrials.gov and PubMed for COVID-19 interventional trials. We analyzed responses to ClinicalTrials.gov fields regarding intent to share individual participant level data and analyzed the data sharing statements in eligible publications.ResultsNine hundred twenty-four trial registrations were analyzed. 15.7% were willing to share, of which 38.6% were willing to share immediately upon publication of results. 47.6% declared they were not willing to share. Twenty-eight publications were analyzed representing 26 unique COVID-19 trials. Only seven publications contained data sharing statements; six indicated a willingness to share data whereas one indicated that data was not available for sharing.ConclusionsAt a time of pressing need for researchers to work together to combat a global pandemic, intent to share individual participant-level data from COVID-19 interventional trials is limited.
Highlights
The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments
Clinical trials are the best source of evidence for guiding the treatment of COVID-19, the disease caused by the novel coronavirus SARS-CoV-2
In this time of global pandemic, it is imperative that results from COVID-19 treatment trials be shared as quickly as possible, ideally with availability of the underlying individual participantlevel trial data (IPD) to enable more complex and flexible analyses and data aggregation than is possible with only summary-level results
Summary
We searched ClinicalTrials.gov and PubMed for COVID-19 interventional trials. We analyzed responses to ClinicalTrials.gov fields regarding intent to share individual participant level data and analyzed the data sharing statements in eligible publications. The IPD Data Sharing Description field contains free-form text explaining “No” and “Undecided” responses in the IPD Data Sharing field. We reviewed these explanations for mismatches on intent to share. If the IPD Data Sharing response was “No” yet the IPD Data Sharing Description field said “the data will be shared upon publication,” the trial was re-classified as a “Yes” on intent to share. Responses to the IPD Data Sharing Timeframe field, which is a free-form text field on when data will be shared, were classified as immediately upon publication, 1 to < 6 months, 6 to 12 months, > 12–24 months, and over 24 months
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