COVID-19: Why SOLIDARITY and DisCoVeRy trials may fail to bring informative and timely results

  1. Mondher Toumi
  2. Shuyao Liang
  3. Monique Dabbous
  4. Yitong Wang
  5. Tingting Qiu
  6. Ru Han

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Abstract

Objective

The SOLIDARITY and DisCoVeRy trials were launched to facilitate the rapid worldwide comparison of the efficacy and safety of treatments against COVID-19. This study aimed to review the trial designs of SOLIDARITY and DisCoVeRy and their feasibility to generate high-quality evidence.

Method

A systematic search of the European Clinical trial registry, the U.S. National Library of Medicine ClinicalTrials.gov , and the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) was conducted on May 10 th , 2020 to identify the study details of the SOLIDARITY and DisCoVeRy trials. A supplementary search of PubMed, WHO’s website, French authorities’ websites, and Google search engine was conducted. A critical review was performed on the findings.

Results

The DisCoVeRy trial design was detailed consistently in both the European and the US clinical rial registries. SOLIDARITY was registered on ICTRP, with country-specific information reported on country-level registry platforms. The DisCoVeRy trial’s design appears to be ideal from the methodological perspective. Both trials appear difficult to implement, impractical, and disconnected from the pandemic reality. This is consistent with the apparent failure of the trials to deliver conclusions before the end of the pandemic.

Conclusion

Both trials constitute an interesting initiative yet may lack the resources to support a high-quality implementation. The authors call for a pandemic task force, with various experts on the front-line of COVID-19, to inform policy-makers to make effective decisions that may not be based on traditional, methodological state-of-the-art evidence, but rather pragmatic and revisable decisions reflecting emerging evidence for the benefit of patients and society.

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  1. ScreenIT

    SciScore for 10.1101/2020.06.01.20118927: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    A supplementary search of PubMed, WHO’s website, French authorities’ websites including MESRI, MSS and Inserm, and Google search engine using the keywords of “SOLIDARITY trial” and “DisCoVeRy trial” was conducted to identify additional information on the progress of the two trials.
    PubMed
    suggested: (PubMed, RRID:SCR_004846)
    Google
    suggested: (Google, RRID:SCR_017097)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2020.06.01.20118927 on medRxiv