임상시험 대상자 모집 광고에 대한 정부의 규제 효과
The Effect of Regulation on Recruitment Advertising for Clinical Trial Subjects in Korea
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.
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.
참고문헌 (35)
- "Public perception survey of COVID-19 vaccine clinical trial"[URL]
- Fairbanks E, "Successful recruitment methods in the community for a two-site clinical trial", Appl Nurs Res, 27(4), pp.254~257 (2014)
- "Current challenges in clinical trial patient recruitment and enrollment" (2004)[URL]
- Kadam RA, "Challenges in recruitment and retention of clinical trial subjects", Perspect Clin Res, 7(3), pp.137~143 (2016)
- McDonald AM, "What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies", Trials, 7(1), pp.1~8 (2006)
- Nathan RA, "How important is patient recruitment in performing clinical trials?", J Asthma, 36(3), pp.213~216 (1999)
- Emanuel EJ, "Ethical and regulatory aspects of clinical research: readings and commentary" (2004), Johns Hopkins University Press
- Wang B, "Analysis of the status of subject recruitment in clinical trials in Shandong, China", J Empir Res Hum Res Ethics, 7(1), pp.9~16 (2012)
- 김원옥, "Institutional review board (IRB) and ethical issues in clinical research", Korean Journal of Anesthesiology, 62(1), pp.3~12 (2012), 대한마취통증의학회
- Paul J, "The Internet and clinical trials:background, online resources, examples and issues", J Med Internet Res, 7(1), pp.e5~ (2005)
- "Clinical trial web site"[URL]
- "Guidance on institutional review board review of clinical trial website" (2005)[URL]
- "Recruiting study subjects" (1998)[URL]
- "Status of approval of clinical trials in 2021"[URL]
- "Clinical trial ‘part-timer’ is an incorrect expression…‘volunteer’ is correct"[URL]
- "Part-time Maruta accused of still making money in clinical trials"[URL]
- "Do you still look like a part of honey? Contrast of clinical and viability tests"[URL]
- "Article 34 Paragraphs 3of the Pharmaceutical Affairs Act"[URL]
- 김현진, "국내 임상시험 대상자 모집 광고문 내용 분석과 평가", 병원약사회지, 39(2), pp.202~218 (2022), 한국병원약사회
- "Uiyagpum-anjeonnara"[URL]
- "Article 24 Paragraph 2of the rules on the safety of medicines"[URL]
- Klitzman R, "Disclosure of information to potential subjects on research recruitment web sites", IRB, 30(1), pp.15~20 (2008)
- Bohaychuk W, "Conducting GCP-compliant clinical research", pp.1~6 (1999), Wiley
- Bohaychuk W, "A quantitative view of international GCP compliance", Appl Clin Trials, 7(2), pp.24~29 (1998)
- Brunier DP, "GCP deficiencies in clinical trials in western and eastern Europe : results of international clinical trial center audits", Appl Clin Trials, 7(3), pp.46~51 (1998)
- Bernstein SL, "Incentives to participate in clinical trials : practical and ethical considerations", Am J Emerg Med, 33(9), pp.1197~1200 (2015)
- Brown JG, "Recruiting human subjects: pressures in industrysponsored clinical research", pp.1~9 (2008), DIANE Publishing
- Emanuel EJ, "What makes clinical research ethical?", JAMA, 283(20), pp.2701~2711 (2000)
- World Medical Association, "Declaration of Helsinki. Ethical principles for medical research involving human subjects", J Indian Med Assoc, 107(6), pp.403~405 (2009)
- Silverman H, "Protecting vulnerable research subjects in critical care trials : enhancing the informed consent process and recommendations for safeguards", Ann Intensive Care, 1(1), pp.8~ (2011)
- "Notice regarding recruitment of clinical trial subjects"[URL]
- "Recommendation on improving the quality of government regulation"[URL]
- Padhy BM, "Analysis of the compliance of informed consent documents with good clinical practice guideline", Contemp Clin Trials, 32(5), pp.662~666 (2011)
- Pitler E, "Revisiting readability: a unified framework for predicting text quality", Proceedings of the 2008 conference on empirical methods in natural language processing, Honolulu, pp.186~195 (2008)
- Kang T, "Initial readability assessment of clinical trial eligibility criteria", AMIA Annu Symp Proc, 2015, pp.687~696 (2015)