Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Clinical Research Center for Food and Herbal Product Trials and Development (CR-FAH), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Clin Trials. 2023 Oct;20(5):517-527. doi: 10.1177/17407745231174528. Epub 2023 May 16.
BACKGROUND/AIMS: An informed consent form is essential in drug development clinical trials. This study aimed to evaluate regulatory compliance and readability of informed consent forms currently being used in industry-sponsored drug development clinical trials.
This descriptive, cross-sectional study evaluated the informed consent forms of industry-sponsored drug development clinical trials conducted at the Faculty of Medicine, Chiang Mai University, between 2019 and 2020. The informed consent form's compliance with the three major ethical guidelines and regulations (i.e. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6(R2) Good Clinical Practice; Declaration of Helsinki; and the revised Common Rule) were analyzed. The document length and the readability scores (using Flesch Reading Ease and Flesch-Kincaid Reading Grade) were assessed.
Of 64 reviewed informed consent forms, the average page length was 22.0 ± 7.4 pages. More than half of their length was mainly devoted to three elements: trial procedures (22.9%), risks and discomforts (19.1%), and confidentiality and the limit of confidentiality (10.1%). Although most of the required elements of the informed consent form content were included in most informed consent forms, we identified four elements with often missing information in the form: aspects of research that are experimental (n = 43, 67.2%), involvement of whole-genome sequencing (n = 35, 54.7%), commercial profit sharing (n = 31, 48.4%), and posttrial provisions (n = 28, 43.8%).
The informed consent forms in industry-sponsored drug development clinical trials were long but incomplete. Our findings draw attention to ongoing challenges in industry-sponsored drug development clinical trials, where deficient informed consent form quality continues to exist.
背景/目的：知情同意书在药物开发临床试验中至关重要。本研究旨在评估当前工业赞助药物开发临床试验中使用的知情同意书的监管合规性和可读性。
本描述性、横断面研究评估了 2019 年至 2020 年在清迈大学医学院进行的工业赞助药物开发临床试验的知情同意书。分析了知情同意书对三大伦理准则和法规（即国际人用药品注册技术协调会 E6(R2)良好临床实践、赫尔辛基宣言和修订后的通用规则）的遵守情况。评估了文件长度和可读性评分（使用 Flesch 阅读容易度和 Flesch-Kincaid 阅读年级）。
在 64 份审查的知情同意书中，平均页数为 22.0±7.4 页。其长度的一半以上主要用于三个要素：试验程序（22.9%）、风险和不适（19.1%）以及保密性和保密性限制（10.1%）。虽然知情同意书内容的大多数必需要素都包含在大多数知情同意书中，但我们发现形式中经常缺少四个要素的信息：研究的实验方面（n=43，67.2%）、全基因组测序的参与（n=35，54.7%）、商业利润分享（n=31，48.4%）和试验后规定（n=28，43.8%）。
工业赞助药物开发临床试验中的知情同意书篇幅较长，但内容不完整。我们的发现提请人们注意工业赞助药物开发临床试验中持续存在的挑战，其中知情同意书质量的不足仍然存在。
