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Discovering treatment effectiveness via median treatment effects-Applications to COVID-19 clinical trials.

ABSTRACT: Comparing median outcomes to gauge treatment effectiveness is widespread practice in clinical and other investigations. While common, such difference-in-median characterizations of effectiveness are but one way to summarize how outcome distributions compare. This paper explores properties of median treatment effects (TEs) as indicators of treatment effectiveness. The paper's main focus is on decisionmaking based on median TEs and it proceeds by considering two paths a decisionmaker might follow. Along one, decisions are based on point-identified differences in medians alongside partially identified median differences; along the other decisions are based on point-identified differences in medians in conjunction with other point-identified parameters. On both paths familiar difference-in-median measures play some role yet in both the traditional standards are augmented with information that will often be relevant in assessing treatments' effectiveness. Implementing either approach is straightforward. In addition to its analytical results the paper considers several policy contexts in which such considerations arise. While the paper is framed by recently reported findings on treatments for COVID-19 and uses several such studies to explore empirically some properties of median-treatment-effect measures of effectiveness, its results should be broadly applicable.

SUBMITTER: Mullahy J

PROVIDER: S-EPMC8068615 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAs COVID-19 cases continue to rise globally, evidence from large randomized controlled trials is still lacking. Currently, numerous trials testing potential treatment and preventative options are being undertaken all over the world.ObjectivesWe summarized all registered clinical trials examining treatment and prevention options for COVID-19. Additionally, we evaluated the quality of the retrieved studies.Data sourcesClinicaltrials.gov, the Chinese Clinical Trial Registry and the European Union Clinical Trials Register were systematically searched.Study eligibility criteriaRegistered clinical trials examining treatment and/or prevention options for COVID-19 were included. No language, country or study design restrictions were applied. We excluded withdrawn or cancelled studies and trials not reporting therapeutic or preventative strategies for COVID-19.Participants and interventionsNo restrictions in terms of participants' age and medical background or type of intervention were enforced.MethodsThe registries were searched using the term 'coronavirus' or 'COVID-19' from their inception until 26 March 2020. Additional manual search of the registries was also performed. Eligible studies were summarized and tabulated. Interventional trials were methodologically analysed, excluding expanded access studies and trials testing traditional Chinese medicine.ResultsIn total, 309 trials evaluating therapeutic management options, 23 studies assessing preventive strategies and three studies examining both were retrieved. Finally, 214 studies were methodologically reviewed. Interventional treatment studies were mostly randomized (n = 150/198, 76%) and open label (n = 73/198, 37%) with a median number of planned inclusions of 90 (interquartile range 40-200). Major categories of interventions that are currently being investigated are discussed.ConclusionsNumerous clinical trials have been registered since the onset of the COVID-19 pandemic. Summarized data on these trials will assist physicians and researchers to promote patient care and guide future research efforts for COVID-19 pandemic containment.

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Discovering treatment effectiveness via median treatment effects-Applications to COVID-19 clinical trials.

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