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COVID-19 与非 COVID-19 适应证治疗和疫苗临床试验的资金来源,2020-2021 年。

Funding Sources of Therapeutic and Vaccine Clinical Trials for COVID-19 vs Non-COVID-19 Indications, 2020-2021.

机构信息

Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom.

Department of Health Policy and LSE Health, London School of Economics and Political Science, London, United Kingdom.

出版信息

JAMA Netw Open. 2022 Aug 1;5(8):e2226892. doi: 10.1001/jamanetworkopen.2022.26892.

Abstract

IMPORTANCE

Effective COVID-19 vaccines and therapeutics reached the market within the first year of the pandemic. This rate of development and availability was an unprecedented achievement that required attention to numerous research and development, regulatory, and policy challenges. However, only limited evidence is currently available on the sources of funding for COVID-19 clinical trials.

OBJECTIVE

To compare the number and funding sources of clinical trials aimed at investigating therapeutics and vaccines for COVID-19 vs those for all non-COVID-19 indications.

DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, clinical trials in phase 1 to 3 that were registered to start between January 1, 2020, and August 31, 2021, were examined. All relevant data were collected from ClinicalTrials.gov.

MAIN OUTCOMES AND MEASURES

Number of clinical trials and their funding sources.

RESULTS

A total of 1977 clinical trials that addressed COVID-19 therapeutics and vaccines were registered worldwide with starting dates from January 1, 2020, to August 31, 2021. This cohort represented 13.9% of all trials (N = 14 274) during the same period. Most of the COVID-19 therapeutic and vaccine clinical trials were funded by public sources (1144 [57.9%]), followed by industry (540 [27.3%]) and public-private partnerships (293 [14.8%]). Most of these studies focused on the development of anti-COVID-19 therapeutics (1680 [85.0%]) rather than vaccines (297 [15.0%]).

CONCLUSIONS AND RELEVANCE

The findings of this study suggest that publicly funded research and medical institutions played a leading role as funding sources for generating effective COVID-19 therapeutics and vaccines during the first 1.5 years of the pandemic and were most likely instrumental in their rapid development. It may be beneficial for the public sector to maintain the affordability and global access to these therapeutics and vaccines to ensure that they remain available for use worldwide.

摘要

重要性

在大流行的第一年,有效的 COVID-19 疫苗和疗法就已经投放市场。这种发展和可获得性的速度是一项前所未有的成就,需要关注众多研发、监管和政策挑战。然而,目前关于 COVID-19 临床试验资金来源的证据有限。

目的

比较旨在研究 COVID-19 治疗方法和疫苗的临床试验数量和资金来源与所有非 COVID-19 适应症的临床试验数量和资金来源。

设计、设置和参与者:在这项横断面研究中,检查了 2020 年 1 月 1 日至 2021 年 8 月 31 日期间登记开始的 1 期至 3 期临床试验。所有相关数据均从 ClinicalTrials.gov 收集。

主要结果和措施

临床试验数量及其资金来源。

结果

全球共登记了 1977 项针对 COVID-19 治疗方法和疫苗的临床试验,起始日期为 2020 年 1 月 1 日至 2021 年 8 月 31 日。这一组占同期所有试验(N=14274)的 13.9%。大多数 COVID-19 治疗和疫苗临床试验由公共来源(1144 [57.9%])资助,其次是工业(540 [27.3%])和公私合作伙伴关系(293 [14.8%])。这些研究大多集中在开发抗 COVID-19 治疗方法(1680 [85.0%])上,而不是疫苗(297 [15.0%])。

结论和相关性

本研究结果表明,在大流行的前 1.5 年,公共资助的研究和医疗机构作为产生有效 COVID-19 治疗方法和疫苗的资金来源发挥了主导作用,并且很可能在其快速发展中发挥了重要作用。为确保这些治疗方法和疫苗在全球范围内继续使用,公共部门维持这些治疗方法和疫苗的可负担性和全球可及性可能是有益的。

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