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A Survey on Methodological Issues of Clinical Research Studies Reviewed by Independent Ethic Committees during the COVID-19 Pandemic in Italy

Author

Listed:
  • Alberto Milanese

    (Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy)

  • Paolo Trerotoli

    (Department of Biomedical Science and Human Oncology, University of Bari Aldo Moro, 70121 Bari, Italy)

  • Annarita Vestri

    (Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy)

  • on behalf of the Biostatisticians Collaborative Group and SISMEC Directive Council

    (Biostatisticians Collaborative Group and SISMEC Directive Council are listed in acknowledgments.)

Abstract

The struggle for information and the hasty search for answers caused by the COVID-19 pandemic threatened the possibility of lowering study quality, as well as ethical committees’ review standards during the outbreak. Our investigation aimed to assess the impact of COVID-19 on the quality of clinical research studies submitted to Italian Ethics Committees in the period between April and July 2020. All 91 Italian ethics committees were contacted via email in order to collect anonymized information on the type and quality of COVID-19-related studies submitted to each committee during the study period. The present study summarizes the characteristics of the 184 study applications collected, pointing out, especially, how the quality of the study population and statistical analysis are crucial variables in determining the study approval. Nevertheless, despite the need for high-quality and open scientific information, especially exacerbated by this particular historical period, only a minority of the ethics committees (20.9%) agreed to share their data; such scarce participation, beyond biasing the representativeness of the results obtained by the present study, more importantly, hinders the broader goal of creating trust between researchers and the general public.

Suggested Citation

  • Alberto Milanese & Paolo Trerotoli & Annarita Vestri & on behalf of the Biostatisticians Collaborative Group and SISMEC Directive Council, 2022. "A Survey on Methodological Issues of Clinical Research Studies Reviewed by Independent Ethic Committees during the COVID-19 Pandemic in Italy," IJERPH, MDPI, vol. 19(18), pages 1-9, September.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:18:p:11673-:d:916576
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    References listed on IDEAS

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    1. Nicole Mather, 2020. "How we accelerated clinical trials in the age of coronavirus," Nature, Nature, vol. 584(7821), pages 326-326, August.
    2. Helen Pearson, 2021. "How COVID broke the evidence pipeline," Nature, Nature, vol. 593(7858), pages 182-185, May.
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