[논문]한국의 다지역 임상시험 가이드라인 적용에 대한 인식: 다중 이해관계자 설문조사

손민지; 송윤경; 전아영; 오정미; 김인화

doi:10.24304/kjcp.2019.29.4.267

[국내논문] 한국의 다지역 임상시험 가이드라인 적용에 대한 인식: 다중 이해관계자 설문조사
Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey 원문보기

한국임상약학회지 = Korean journal of clinical pharmacy, v.29 no.4, 2019년, pp.267 - 277

손민지 (서울대학교 약학대학, 종합약학연구소) , 송윤경 (서울대학교 약학대학, 종합약학연구소) , 전아영 (서울대학교 약학대학, 종합약학연구소) , 오정미 (서울대학교 약학대학, 종합약학연구소) , 김인화 (서울대학교 약학대학, 종합약학연구소)

Abstract ▼ AI-Helper

Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.

주제어

AI 본문요약
AI-Helper

* AI 자동 식별 결과로 적합하지 않은 문장이 있을 수 있으니, 이용에 유의하시기 바랍니다.

문제 정의

¹⁴⁾ Despite the potential benefits of the MRCT guideline, little is known about the stakeholders’ perspectives on their use in Korea. The goal of this study was therefore to assess the developed guideline and the perspectives of various Korean stakeholders.

제안 방법

According to our results, it is profitable to follow international trends and to carry out the two preparatory steps for approximately two years before execution. The final application stage involves the education and promotion of the MRCT guideline, followed by further improvements resulting from trial and error. Previous recognition of MRCTs was lowest in the CRO group and the department of approval and registration; for this reason, the guideline must be promoted, especially within that group.
Participants were asked to answer Yes or No when asked whether they had prior recognition of the ICH guidelines for MRCTs. The questions used either a multiple-choice format, or a 5-point Likert scale, with the scales ranging from 1 (very unnecessary) to 5 (very necessary) for adopting the guideline; from 1 (very incomprehensible) to 5 (very comprehensible) for the content of the guideline; and from 1 (very inappropriate to 5 (very appropriate) for the level of the guideline and their impact on systemic/political, academic/technical, and industrial/economical aspects. Open-ended questions asked participants to explain their reasons for each response.
The survey was entitled Investigation of perspectives on adopting the guideline for multi-regional clinical trials; it began with a disclosure statement that described the essential aspects of the research, including its goals, objectives, risks, benefits, protection of personal information, and informed consent procedure. Perspectives on adopting the guidelines were evaluated in accordance with three themes: prior recognition, local environmental impact, and adoption period.
Open-ended questions asked participants to explain their reasons for each response. The survey was provided with the draft of ICH MRCT guideline to understand the original meaning and the draft of Korean MRCT guideline which was slightly modified by consultation meeting.
This study is the first to investigate the adoption of MRCT guideline by examining the perspectives of three key stakeholders, using an online survey. The results show that stakeholders consider the content of the guideline to be appropriate, in terms of clarity, acceptability, and applicability.

대상 데이터

A total of 106 participants were enrolled to the survey. Of these, 94 responded to the survey and 12 were excluded for giving their consent but not answering any of the other questions.
The respondents were recruited from three key stakeholder groups: pharmaceutical companies (PCs), clinical research organizations (CROs), and clinical trial centers (CTCs). To be eligible for this study, all candidates were required to have work experience related to clinical trials (e.

데이터처리

For the 5-point Likert scales, scores were compared using means and standard deviation (SD) and categorized as appropriate (3 points or more) or good (4 points or more), using percentages. According to the normality and variance, the differences in scores between the subgroups were analyzed with non parametric Kruskal Wallis test and post hoc comparisons by Mann-Whitney U-test with Bonferroni correction. Adjusted p-values less than 0.

성능/효과

3%). Eighty-six participants answered the open-ended question about adoption time; the key issues that concerned them involved preparation time (41.9%), the guideline requirements (22.1%), the need to ensure sufficient discussion (12.8%), whether Korea should follow international trends (12.8%), and the domestic environment (10.5%) (Fig. 1D). In summary, the guideline was sure necessary to adapt, but it still needed further review and discussion.
2A. Of the whole pool of respondents, 66 (70.2%) had prior recognition of the ICH E17 guideline; of these, 15 (71.4%) were at the CTC site, 35 (68.6%) at the PC site, and 7 (63.6%) at the CRO site. Categorizing the participants by work department showed that 13 (65.

참고문헌 (40)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E17 General principles for planning and design of Multi-Regional Clinical Trials Draft. ICH 2016. Available from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17EWG_Step2_2016.pdf. Accessed August 26, 2016.
Weisfeld V and Lustig TA. International Regulatory Harmonization Amid Globalization of Drug Development. In: Workshop Summary of Forum on Drug Discovery, Development, and Translation; Board on Health Sciences Policy; Institute of Medicine (IOM), Washington, Oct 24, 2013:5-9.
Quan H, Mao X, Tanaka Y, et al. Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials. Contemp Clin Trials 2017;58:13-22.

상세보기
Shenoy P. Multi-regional clinical trials and global drug development. Perspect Clin Res 2016;7:62-7.

상세보기
Vickers A, Goyal N, Harland R, et al. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials 1998;19:159-66.

상세보기
Okie S. Multinational medicines-ensuring drug quality in an era of global manufacturing. N Engl J Med 2009;361:737-40.

상세보기
Davis JR, Nolan VP, Woodcock J, et al. Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. In: Workshop Report of Institute of Medicine (US) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Washington, April 14-15, 1998.
Song Y, Sohn M, Jeon AY, et al. Regulations and guidelines for planning and design of multi-regional clinical trials. Korean J Clin Pharm 2018;28:146-53.

원문보기 상세보기
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Basic principles on global clinical trials. PMDA 2007. Available from https://www.pmda.go.jp/files/000153265.pdf. Accessed December 4, 2019.
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Basic Principles on Global Clinical Trials (Reference Cases). PMDA 2012. Available from https://www.pmda.go.jp/files/000157520.pdf. Accessed December 4, 2019.
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials. PMDA 2014. Available from https://www.pmda.go.jp/files/000157777.pdf. Accessed December 4, 2019.
National Medical Products Administration. International multicenter clinical trials Guidelines (Trial) Draft. CFDA 2014. Available from http://samr.cfda.gov.cn/WS01/CL0001/. Accessed August 26, 2016.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E17 General principles for planning and design of Multi-Regional Clinical Trials. ICH 2017. Available from https://database.ich.org/sites/default/files/E17EWG_Step4_2017_1116.pdf. Accessed December 4, 2019.
Gastroenterology and Metabolism Products Division, Drug Evaluation Department. General principles for planning and design of Multi-Regional Clinical Trials. National Institue of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety 2018. Available from http://www.nifds.go.kr/brd/m_15/view.do?seq12555&srchFr&srchTo&srchWord&srchTp&itm_seq_10&itm_seq_20&multi_itm_seq0&company_cd&company_nm&page1. Accessed December 4, 2019.
Dillman DA, Smyth JD, Christian LM. Internet, Mail and Mixed-Mode Surveys: The Tailored Design Method, 3rd Edition. Hoboken: Wiley, 2009:94-168, 301-50.
Reagans R. Survey Sample Size Calculator. Available from http://fluidsurveys.com/university/survey-sample-size-calculator/. Accessed August 26, 2016.
Brouwers MC, Kho ME, Browman GP, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ 2010;182:E839-42.

상세보기
Fervers B, Burgers JS, Voellinger R, et al. Guideline adaptation: an approach to enhance efficiency in guideline development and improve utilisation. BMJ Qual Saf 2011;20:228-36.

상세보기
Hsieh HF and Shannon SE. Three approaches to qualitative content analysis. Qual Health Res 2005;15:1277-88.

상세보기
Elo S and Kyngas H. The qualitative content analysis process. J Adv Nurs 2008;62:107-15.

상세보기
Tavakol M and Dennick R. Making sense of Cronbach's alpha. Int J Med Educ 2011;2:53-5.

상세보기
Binkowitz B and Ibia E. Multiregional Clinical Trials: An Introduction From an Industry Perspective. Drug Inf J 2011;45:569-73.

상세보기
Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother 2015;6:185-7.

상세보기
Siering U, Eikermann M, Hausner E, et al. Appraisal tools for clinical practice guidelines: a systematic review. PLoS One 2013;8:e82915.

상세보기
MacDermid JC, Brooks D, Solway S, et al. Reliability and validity of the AGREE instrument used by physical therapists in assessment of clinical practice guidelines. BMC Health Serv Res 2005;5:18.

상세보기
Hoffmann-Esser W, Siering U, Neugebauer EAM, et al. Guideline Appraisal With AGREE II: Systematic Review of the Current Evidence on How Users Handle the 2 Overall Assessments. PLoS One 2017;12:e0174831.

상세보기
Zhang X, Zhao K, Bai Z, et al. Clinical Practice Guidelines for Hypertension: Evaluation of Quality Using the AGREE II Instrument. Am J Cardiovasc Drugs 2016;16:439-51.

상세보기
Yang C, Zhang Z, Zhang L, et al. Quality assessment of clinical practice guidelines on tic disorders with AGREE II instrument. Psychiatry Res 2018;259:385-91.

상세보기
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. E5(R1) Ethnic Factors in the Acceptabilify of Foreign Clinical Data. ICH 1998. Available from https://database.ich.org/sites/default/files/E5_R1__Guideline.pdf. Accessed December 4, 2019.
Yi S, An H, Lee H, et al. Korean, Japanese, and Chinese populations featured similar genes encoding drug-metabolizing enzymes and transporters: a DMET Plus microarray assessment. Pharmacogenet Genomics 2014;24:477-85.

상세보기
Hasunuma T, Tohkin M, Kaniwa N, et al. Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians. Br J Clin Pharmacol 2016;81:1078-90.

상세보기
Gehring M, Taylor RS, Mellody, et al. Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study). BMJ Open 2013;3:e002957.

상세보기
Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009;180:277-8.

상세보기
Korean National Enterprise for Clinical Trials. The right place for clinical tirals in Asia. KoNECT 2017. Available from https://www.konect.or.kr/upload/downfile/Start_with_Korea_2017.pdf. Accessed December 4, 2019.
Rajadhyaksha V. Conducting feasibilities in clinical trials: an investment to ensure a good study. Perspect Clin Res 2010;1:106-9.
Chen J, Quan H, Gallo P, et al. An adaptive strategy for assessing regional consistency in multiregional clinical trials. Clin Trials 2012;9:330-9.

상세보기
Tsou HH, Tsong Y, Chang WJ, et al. Design and analysis issues of multiregional clinical trials with different regional primary endpoints. J Biopharm Stat 2012;22:1051-9.

상세보기
Chen YH and Wang M. Assessing dose-region profile of drug efficacy: a multiregional trial strategy. J Biopharm Stat 2012;22:894-902.

상세보기
Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32:1008-15.
Wong LP. Focus group discussion: a tool for health and medical research. Singapore Med J 2008;49:256-60.

상세보기

저자의 다른 논문 :

표제어: PCR

동의어: Packet Collision Rate

용어 설명 출처 목록 (6)

용어 설명: PCR은 세균 특이성이 있는 primer를 이용하여 적은 수의 세균이 있을지라도 쉽게 검출할 수 있는 유용한 방법이며, 이를 이용하여 구강 내 치면세균막이나 타액에서 직접 세균을 검출할 수 있게 되었다[8].

내보내기 구분	파일저장 인쇄 메일전송
구성항목	기본정보 상세정보 관리번호, 논문명, 저널/프로시딩명, 저자 , 발행년, 권, 호, 시작페이지, 끝페이지, 발행기관 관리번호, 논문명, 대등논문명, 저자 , 저널/프로시딩명, 발행기관, 발행년, 발행언어, 권, 호, 시작페이지, 끝페이지, ISBN, ISSN, 주제분야, 키워드, 초록(한글), 초록(영문), 저자(소속기관)
저장형식	Text(ASCII format) Excel format RefWorks Direct Export RIS format (for Reference Manager, ProCite, EndNote), Scholar's Aids, Mendeley
메일정보	받는사람 (필수) @ 보내는사람 (선택) @ 제목 내용 KISTI 검색결과 이메일 서비스
안내	총 건의 자료가 검색되었습니다. 다운받으실 자료의 인덱스를 입력하세요. (1-10,000) 검색결과의 순서대로 최대 10,000건 까지 다운로드가 가능합니다. 데이타가 많을 경우 속도가 느려질 수 있습니다.(최대 2~3분 소요) 다운로드 파일은 UTF-8 형태로 저장됩니다. 파일의 내용이 제대로 보이지 않을실 때는 웹브라우저 상단의 보기 -> 인코딩 -> 자동선택 여부를 확인하십시오. ~ Text(ASCII format) Excel format

연합인증