Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov

Abstract Background There are several challenges in designing clinical trials for the treatment of novel infectious diseases, such as COVID-19. In particular, the definition of endpoints related to the severity, time frame, and clinical course remains unclear. Therefore, we conducted a cross-section...

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Autores principales:	Kentaro Sakamaki, Yukari Uemura, Yosuke Shimizu
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	COVID-19 Characteristics of endpoints Clinical course Time frame Phase III trials Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/18ac7fa14e8c498cb9fa73e033015f7a
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spelling	oai:doaj.org-article:18ac7fa14e8c498cb9fa73e033015f7a2021-11-14T12:31:13ZDefinitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov10.1186/s13063-021-05763-y1745-6215https://doaj.org/article/18ac7fa14e8c498cb9fa73e033015f7a2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05763-yhttps://doaj.org/toc/1745-6215Abstract Background There are several challenges in designing clinical trials for the treatment of novel infectious diseases, such as COVID-19. In particular, the definition of endpoints related to the severity, time frame, and clinical course remains unclear. Therefore, we conducted a cross-sectional analysis of phase III randomized trials for COVID-19 registered at ClinicalTrials.gov . Methods We collected the data from ClinicalTrials.gov on March 31, 2021, by specifying the following search conditions under Advanced Search: Condition or disease: (COVID-19) OR (SARS-CoV-2); Study type: Interventional Studies; Study Results: All Studies; Recruitment: Not yet recruiting, Recruiting, Enrolling by invitation, Active, Not recruiting, Suspended, Completed; Sex: All; and Phase: Phase 3. From the downloaded search results, we selected trials that met the following criteria: Primary Purpose: Treatment; Allocation: Randomized. We manually transcribed information not included in the downloaded file, such as Primary Outcome Measures, Secondary Outcome Measures, Time Frame, and Inclusion Criteria. In the analysis, we examined primary and secondary endpoints in trials with severe and non-severe patients, including the types of endpoints, time frame, clinical course, and sample size. Results A total of 406 trials were included in the analysis. The median numbers of endpoints in trials with severe and non-severe patients were 9 and 7, respectively. Approximately 25% of the trials used multiple primary endpoints. Regardless of the type of endpoint, the time frames were longer in the trials with severe patients than in the trials with non-severe patients. In the evaluation of the clinical course, worsening was often considered in binary endpoints, and improvement was considered in time-to-event endpoints. The sample size was the largest in clinical trials using binary endpoints. Conclusions Endpoints can differ with respect to severity, and the clinical course and time frame are important for defining endpoints. This study provides information that can facilitate the achievement of a consensus for the endpoints in evaluating COVID-19 treatments.Kentaro SakamakiYukari UemuraYosuke ShimizuBMCarticleCOVID-19Characteristics of endpointsClinical courseTime framePhase III trialsMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 Characteristics of endpoints Clinical course Time frame Phase III trials Medicine (General) R5-920
spellingShingle	COVID-19 Characteristics of endpoints Clinical course Time frame Phase III trials Medicine (General) R5-920 Kentaro Sakamaki Yukari Uemura Yosuke Shimizu Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov
description	Abstract Background There are several challenges in designing clinical trials for the treatment of novel infectious diseases, such as COVID-19. In particular, the definition of endpoints related to the severity, time frame, and clinical course remains unclear. Therefore, we conducted a cross-sectional analysis of phase III randomized trials for COVID-19 registered at ClinicalTrials.gov . Methods We collected the data from ClinicalTrials.gov on March 31, 2021, by specifying the following search conditions under Advanced Search: Condition or disease: (COVID-19) OR (SARS-CoV-2); Study type: Interventional Studies; Study Results: All Studies; Recruitment: Not yet recruiting, Recruiting, Enrolling by invitation, Active, Not recruiting, Suspended, Completed; Sex: All; and Phase: Phase 3. From the downloaded search results, we selected trials that met the following criteria: Primary Purpose: Treatment; Allocation: Randomized. We manually transcribed information not included in the downloaded file, such as Primary Outcome Measures, Secondary Outcome Measures, Time Frame, and Inclusion Criteria. In the analysis, we examined primary and secondary endpoints in trials with severe and non-severe patients, including the types of endpoints, time frame, clinical course, and sample size. Results A total of 406 trials were included in the analysis. The median numbers of endpoints in trials with severe and non-severe patients were 9 and 7, respectively. Approximately 25% of the trials used multiple primary endpoints. Regardless of the type of endpoint, the time frames were longer in the trials with severe patients than in the trials with non-severe patients. In the evaluation of the clinical course, worsening was often considered in binary endpoints, and improvement was considered in time-to-event endpoints. The sample size was the largest in clinical trials using binary endpoints. Conclusions Endpoints can differ with respect to severity, and the clinical course and time frame are important for defining endpoints. This study provides information that can facilitate the achievement of a consensus for the endpoints in evaluating COVID-19 treatments.
format	article
author	Kentaro Sakamaki Yukari Uemura Yosuke Shimizu
author_facet	Kentaro Sakamaki Yukari Uemura Yosuke Shimizu
author_sort	Kentaro Sakamaki
title	Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov
title_short	Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov
title_full	Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov
title_fullStr	Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov
title_full_unstemmed	Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov
title_sort	definitions and elements of endpoints in phase iii randomized trials for the treatment of covid-19: a cross-sectional analysis of trials registered in clinicaltrials.gov
publisher	BMC
publishDate	2021
url	https://doaj.org/article/18ac7fa14e8c498cb9fa73e033015f7a
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Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov

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