Study on the Emotional Status and Rights Protection of Participants in Drug Clinical Trials during Epidemic Prevention and Control
10.12026/j.issn.1001-8565.2023.04.15
- VernacularTitle:疫情防控期间药物临床试验研究参与者情绪状况及权益保护研究
- Author:
Yurong ZHANG
1
;
Rui XU
1
;
Qi ZHANG
2
;
Lili ZHAO
1
;
Enze LI
1
;
Xin WANG
3
;
Li WANG
1
Author Information
1. Institution of Drug Clinical Trail, the First Affiliated Hospital of Xi’an Medical University, Xi’an 710077, China
2. Center for Shaanxi Drug and Vaccine Inspection, Xi’an 710065, China
3. Xi’an Evidence-Based Medicine Tech Co.,Ltd, Xi’an 710082, China
- Publication Type:Journal Article
- Keywords:
Epidemic Prevention and Control;
Drug Clinical Trial;
Rights and Interests of Participants;
Emotion
- From:
Chinese Medical Ethics
2023;36(4):443-448
- CountryChina
- Language:Chinese
-
Abstract:
【Objective:】 To analyze the emotional status and follow-up status of the participants in the drug clinical trials in a hospital during the epidemic prevention and control, with a view to maximizing the protection of participants’ rights and interests under special circumstances. 【Methods:】 The general information, depression screening scale (PHQ-9), anxiety screening scale (GAD-7) and subject compliance assessment scale were completed online by participants with gold data questionnaire. At the same time, the status of drug clinical trials under study and the follow-up status of participants under study were collected from November 1, 2021 to December 8, 2021 and from December 9, 2021 to January 24, 2022. Excel software and SPSS18.0 software were used for data statistics and analysis. 【Results:】 During the epidemic prevention and control, there were 20 drug clinical trial projects under way in the hospital. From December 9, 2021 to January 24, 2022, the planned number of visits was 161, and the actual number of visits to the hospital was 84 (52.2%). Plus 24 participants who mailed drugs, the overall visit rate was 67.1%, among which the visit rates of oral drugs, non-oral drugs, and oral drugs combined with non-oral drugs were 79.3%, 71.9%, and 41.0% respectively. From November 1, 2021 to December 8, 2021, the planned number of visits was 166, the actual number of visits to the hospital was 157 (94.6%), and the number of telephone visits accounted for 1.8% of the total planned number of visits. The number of participants who did not take the drug and those who delayed taking the drug were both 0. The total compliance of participants was as high as 80.0%. A total of 40 valid questionnaires were retrieved, and the detection rates of depression and anxiety were 42.5% and 30.0% respectively. 【Conclusion:】 The epidemic prevention and control has a large short-term impact on the follow-up of the participants under study. The formulation of relevant follow-up measures and the conduction of classification management can not only improve the emotions of the participants to a certain extent, but also protect the rights and interests of participants, providing suggestions for the follow-up of participants under emergencies in the future.
