국내 임상시험 대상자 모집 광고문 내용 분석과 평가
Assessment and Analysis of Recruitment Resources for Clinical Trial Subjects in Korea
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Background : Clinical trials (CTs) are important and essential procedures for the treatment of diseases and advancing medicine, but recruitment of subjects involves a lot of time and cost. Enrollment of subjects in CTs is an important factor for proving the hypothesis, but subjects in CTs are exposed to the potential risks of CTs. Therefore, voluntary participation should be premised, and for purpose, sufficient information related to the CT should be provided in an easy-to-understand manner. This study examined the contents of CT recruitment resources that provide initial information about CTs. Methods : Convenience sampling was employed for the collection of CT recruitment materials. Statistical analysis using the chi-square test analyzed the difference between printed materials and web-based materials, and logistic regression analysis was performed to analyze factors affecting the provided contents and technical terminology. Results : A total of 162 data were collected and analyzed. All materials included ‘inclusion criteria (100%)’ and ‘contact information (100%)’, and web-based materials had more document formats without visual effects than printed materials (p<.01). Web-based materials provided more detailed information such as ‘study methods’ (p<.001) and ‘Information of the investigational product’ (p<.001) than printed materials, and ‘Clinical trial process’ jargon (p<.001) and ‘Diagnosis terms’(p<.001) were used more frequently. Compared with public transportation materials, the use of technical terminologies, such as ‘efficacy, safety, and tolerability’ was about 5.2 times (OR=5.2, 95% CI: 1.90-14.18, p<.01) higher in the website of the CT center and about 10 times (OR= 10.06, 95% CI: 11.67-339.84, p<.001) higher in the web-based CT online platform. Conclusion : Although CT recruitment resources varied and they provided adequate amount and scope of information, the use of technical terminology was high, which could be a barrier to recruitment. Therefore, it is necessary to convert technical terms into plain terms in order to respect voluntary participation and guarantee the rights of subjects.
Abstract
Background : Clinical trials (CTs) are important and essential procedures for the treatment of diseases and advancing medicine, but recruitment of subjects involves a lot of time and cost. Enrollment of subjects in CTs is an important factor for proving the hypothesis, but subjects in CTs are exposed to the potential risks of CTs. Therefore, voluntary participation should be premised, and for purpose, sufficient information related to the CT should be provided in an easy-to-understand manner. This study examined the contents of CT recruitment resources that provide initial information about CTs. Methods : Convenience sampling was employed for the collection of CT recruitment materials. Statistical analysis using the chi-square test analyzed the difference between printed materials and web-based materials, and logistic regression analysis was performed to analyze factors affecting the provided contents and technical terminology. Results : A total of 162 data were collected and analyzed. All materials included ‘inclusion criteria (100%)’ and ‘contact information (100%)’, and web-based materials had more document formats without visual effects than printed materials (p<.01). Web-based materials provided more detailed information such as ‘study methods’ (p<.001) and ‘Information of the investigational product’ (p<.001) than printed materials, and ‘Clinical trial process’ jargon (p<.001) and ‘Diagnosis terms’(p<.001) were used more frequently. Compared with public transportation materials, the use of technical terminologies, such as ‘efficacy, safety, and tolerability’ was about 5.2 times (OR=5.2, 95% CI: 1.90-14.18, p<.01) higher in the website of the CT center and about 10 times (OR= 10.06, 95% CI: 11.67-339.84, p<.001) higher in the web-based CT online platform. Conclusion : Although CT recruitment resources varied and they provided adequate amount and scope of information, the use of technical terminology was high, which could be a barrier to recruitment. Therefore, it is necessary to convert technical terms into plain terms in order to respect voluntary participation and guarantee the rights of subjects.
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