Pride and Prejudice during the COVID-19 Pandemic: The Misfortune of Inappropriate Clinical Trial Design
FH and SKH contributed equally to this work.
- DOI
- 10.2991/jegh.k.200729.001How to use a DOI?
- Keywords
- Clinical trials; single-arm; COVID-19; multi-center; primary endpoint
- Abstract
Coronavirus Disease 2019 (COVID-19) is a rapidly evolving global pandemic for which more than a thousand clinical trials have been registered to secure therapeutic effectiveness, expeditiously. Most of these are single-center non-randomized studies rather than multi-center, randomized controlled trials. Single-arm trials have several limitations and may be conducted when spontaneous improvement is not anticipated, small placebo effect exists, and randomization to a placebo is not ethical. In an emergency where saving lives takes precedence, it is ethical to conduct trials with any scientifically proven design, however, safety must not be compromised. A phase II or III trial can be conducted directly in a pandemic with appropriate checkpoints and stopping rules. COVID-19 has two management paradigms- antivirals, or treatment of its complications. Simultaneous assessment of two different treatments can be done using 2 × 2 factorial schema. World Health Organization’s SOLIDARITY trial is a classic example of the global research protocol which can evaluate the preferred treatment to combat COVID-19 pandemic. Short of that, a trial design must incorporate the practicality of the intervention used, and an appropriate primary endpoint which should ideally be a clinical outcome. Collaboration between institutions is needed more than ever to successfully execute and accrue in randomized trials.
- Copyright
- © 2020 The Authors. Published by Atlantis Press International B.V.
- Open Access
- This is an open access article distributed under the CC BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/).
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TY - JOUR AU - Shahrukh K. Hashmi AU - Edward De Vol AU - Fazal Hussain PY - 2020 DA - 2020/08/07 TI - Pride and Prejudice during the COVID-19 Pandemic: The Misfortune of Inappropriate Clinical Trial Design JO - Journal of Epidemiology and Global Health SP - 15 EP - 19 VL - 11 IS - 1 SN - 2210-6014 UR - https://doi.org/10.2991/jegh.k.200729.001 DO - 10.2991/jegh.k.200729.001 ID - Hashmi2020 ER -