Benchmarking Site Activation and Patient Enrollment

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-04-03 DOI:10.1007/s43441-024-00638-1
Mary Jo Lamberti, Abigail Dirks, Nicholas Kikuchi, Neha Patel Cervantes, Kenneth Getz
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Abstract

Clinical trial conduct poses numerous challenges, many pertaining to patient recruitment. The primary objectives of this study were to update benchmarks on site activation and patient enrollment gathered in previous Tufts CSDD studies and examine current usage of recruitment and retention tactics. The data collection focused on site activation and patient enrollment metrics used for studies. Analyses were conducted comparing results from 2012, 2019 and 2023. The results indicate that actual enrollments exceeded planned enrollments for a majority of studies and timelines were shorter than expected. In addition, differences were found for enrollment achievement by global region and site type. Further investigation into studies conducted during a later time frame and post-pandemic could be compared with current benchmarks to examine differences.

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网站激活和患者注册基准测试
临床试验的开展面临着诸多挑战,其中许多与患者招募有关。本研究的主要目的是更新塔夫茨 CSDD 先前研究中收集的研究机构激活和患者注册基准,并检查当前招募和保留策略的使用情况。数据收集的重点是研究中使用的现场激活和患者注册指标。分析比较了 2012 年、2019 年和 2023 年的结果。结果表明,大多数研究的实际注册人数超过了计划注册人数,时间也比预期的要短。此外,根据全球地区和研究机构类型的不同,入学率也存在差异。可进一步调查在较晚时间段和大流行后进行的研究,并与当前基准进行比较,以检查差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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