Trends in the Burden for Patients Participating in Industry-Funded Clinical Trials.

IF 1.9 4区医学 Q4 MEDICAL INFORMATICS

Therapeutic innovation & regulatory science Pub Date : 2025-09-01 Epub Date: 2025-06-08 DOI:10.1007/s43441-025-00805-y

Abigail Dirks, Emily Botto, Zachary Smith, Kenneth Getz

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Abstract

Background: During the past five years, there has been growing interest among pharmaceutical companies in incorporating patient needs and preferences early in the protocol design process. Through individual and larger group studies, the Tufts Center for the Study of Drug Development (Tufts CSDD) has collaborated with 14 pharmaceutical companies in applying a validated approach early in the protocol design process to assess patient participation burden. Data from these assessments has been aggregated to analyze trends in participation burden between 2011 and 2022.

Methods: 156 phase II and III protocols were analyzed.

Results: Overall burden for patients to participate in phase II and III clinical trials has been rising steadily since 2011. Procedures contributing most to participation burden include patient questionnaires, lab and blood work and routine procedures conducted at each planned visit. A notable increase in the average duration of each visit per protocol was observed in large part due to the volume of procedures performed per visit. A growing proportion of procedures contributing to participation burden are those supporting supplementary, tertiary and exploration endpoints. The results of this aggregate analysis demonstrate the value of assessing patient participation burden to inform protocol design optimization.

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参与行业资助临床试验的患者负担趋势

背景：在过去的五年中，制药公司越来越关注在方案设计过程的早期纳入患者的需求和偏好。塔夫茨药物开发研究中心（Tufts CSDD）与14家制药公司合作，通过个人和更大的群体研究，在方案设计过程的早期应用一种经过验证的方法来评估患者参与负担。汇总这些评估的数据，以分析2011年至2022年期间参与负担的趋势。方法：对156个II期和III期方案进行分析。结果：2011年以来，参与II期和III期临床试验的患者总体负担稳步上升。对参与负担贡献最大的程序包括患者问卷调查、实验室和血液检查以及每次计划就诊时进行的常规程序。每个方案每次就诊的平均持续时间显著增加，这在很大程度上是由于每次就诊所执行的程序数量。在增加参与负担的程序中，支持补充、第三和勘探端点的程序所占比例越来越大。这一综合分析的结果证明了评估患者参与负担对方案设计优化的价值。

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 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