|
KMID : 0941820220320030166
|
|
Korean Journal of Clinical Pharmacy
2022 Volume.32 No. 3 p.166 ~ p.177
|
|
|
The Effect of Regulation on Recruitment Advertising for Clinical Trial Subjects in Korea
|
|
Kim Hyun-Jin
Sohn Hyun-Soon
|
|
|
Abstract
|
|
|
Background: Recently clinical trials have expanded extensively in Korea; thus, ensuring the rights of subjects participating inclinical trials is imperative. Accordingly, national regulations on subject recruitment advertisement were enforced from October 25,2018. In this study, the effect of this regulation was evaluated by analyzing the difference in the provision of information before andafter enforcement of the regulation.
Methods: Recruitment advertisements for clinical trial subjects 3 years before and afterenforcement of the regulation were collated by the significance sampling approach. Print-based (newspapers, buses, and subways)and web-based (clinical trial center websites and online platforms) materials for recruitment in clinical trials of phase 1 to 4 forinvestigational drugs, medical devices, and oriental medicine were considered. Chi-square tests were conducted for inter-groupcomparisons. SPSS version 26 was employed for statistical analyses.
Results: A total of 137 advertisements were collectedcomprising 60 pre- and 77 post-regulation enforcement. The overall rate of delivery of critical information in advertisementsincreased significantly from 47.5% before regulation to 93.2% after regulation enforcement. Particularly, details on expectedadverse events augmented significantly (p<0.001). Benefits from participation in clinical trial reduced significantly from 88.3% to70.1% (p<0.05). As the information provision amplified, the inclusion of professional terms increased.
Conclusions: Enforcement ofregulations has led to a surge in the amount of information and challenging terms contained in advertisements for recruiting subjects. Therefore, additional efforts are required by subjects to completely understand the information provided in the advertisements.
|
|
|
KEYWORD
|
|
|
Research subject recruitment, clinical trials, regulation, advertisements
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|