2023
DOI: 10.1001/jama.2023.4590
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Sharing of Individual Patient-Level Data by Trialists of Randomized Clinical Trials of Pharmacological Treatments for COVID-19

Abstract: This study describes access to individual patient-level data from randomized clinical trials during the COVID-19 pandemic to determine whether the intent to share what was reported in the registry, publication, or preprint was consistent with actual data access.

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Cited by 11 publications
(5 citation statements)
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“…During the pandemic, particularly during its early phase, an impressive amount of reports have been published, but often lacking rigorous methodology ( 359 ) and yielding contradictory or unreliable results. Furthermore, global data sharing and accessibility have been rather limited ( 360 ), which still leaves plenty of room for exploration and consolidation of current knowledge. Detailed mechanistic studies and longer term follow-up of PASC will tell us whether and to what extent metabolic alterations are persisting or fully reversible.…”
Section: Conclusion and Future Perspectivesmentioning
confidence: 99%
“…During the pandemic, particularly during its early phase, an impressive amount of reports have been published, but often lacking rigorous methodology ( 359 ) and yielding contradictory or unreliable results. Furthermore, global data sharing and accessibility have been rather limited ( 360 ), which still leaves plenty of room for exploration and consolidation of current knowledge. Detailed mechanistic studies and longer term follow-up of PASC will tell us whether and to what extent metabolic alterations are persisting or fully reversible.…”
Section: Conclusion and Future Perspectivesmentioning
confidence: 99%
“…Our recommendations are complementary to others working in this space, for example, making electronic CRFs more findable, accessible, interoperable, and reusable (FAIR) to support better reuse of clinical research data 20 and auditing if planned data sharing aligns with post-publication reality 21 . A final advantage of defining a standard data model for atomic, individual patient-level data is that the code for transforming curated data into derived variables can be shared across participating sites and reused in multiple trials 22 .…”
Section: Discussionmentioning
confidence: 96%
“…The development of drugs, whether approved or not, requires time and funding to determine the therapeutic target, the drug's toxicity, and how to use it properly. 52,53 It has been challenging to draw any consistently valid conclusions about the efficacy of drugs in the treatment of COVID-19 disease 54,55 ; so far the cure has not been achieved with the use of a single particular drug. 52,56 Therefore, it is very important to continue studying potential new therapeutic targets such as: drug repurposing strategies, pan-coronavirus drug targets, in vitro assays, mouse models against SARS-CoV-2 and next Strains.…”
Section: Discussionmentioning
confidence: 99%