Browse > Article
http://dx.doi.org/10.24304/kjcp.2019.29.4.267

Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey  

Sohn, Minji (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University)
Song, Yun-Kyoung (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University)
Jeon, Ah Young (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University)
Oh, Jung Mi (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University)
Kim, In-Wha (College of Pharmacy and Research Institute of Pharmaceutical Science, Seoul National University)
Publication Information
Korean Journal of Clinical Pharmacy / v.29, no.4, 2019 , pp. 267-277 More about this Journal
Abstract
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.
Keywords
Multi-regional clinical trial; global drug development; regulatory science; international conference on harmonisation; guideline;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 Rajadhyaksha V. Conducting feasibilities in clinical trials: an investment to ensure a good study. Perspect Clin Res 2010;1:106-9.   DOI
2 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.   DOI
3 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.   DOI
4 Chen YH and Wang M. Assessing dose-region profile of drug efficacy: a multiregional trial strategy. J Biopharm Stat 2012;22:894-902.   DOI
5 Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000;32:1008-15.   DOI
6 Wong LP. Focus group discussion: a tool for health and medical research. Singapore Med J 2008;49:256-60.
7 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.   DOI
8 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.
9 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.
10 Shenoy P. Multi-regional clinical trials and global drug development. Perspect Clin Res 2016;7:62-7.   DOI
11 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.   DOI
12 Okie S. Multinational medicines-ensuring drug quality in an era of global manufacturing. N Engl J Med 2009;361:737-40.   DOI
13 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.
14 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.   DOI
15 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.
16 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.
17 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.
18 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.
19 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.
20 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?seq=12555&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1. Accessed December 4, 2019.
21 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.
22 Reagans R. Survey Sample Size Calculator. Available from http://fluidsurveys.com/university/survey-sample-size-calculator/. Accessed August 26, 2016.
23 Brouwers MC, Kho ME, Browman GP, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ 2010;182:E839-42.   DOI
24 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.   DOI
25 Hsieh HF and Shannon SE. Three approaches to qualitative content analysis. Qual Health Res 2005;15:1277-88.   DOI
26 Elo S and Kyngas H. The qualitative content analysis process. J Adv Nurs 2008;62:107-15.   DOI
27 Tavakol M and Dennick R. Making sense of Cronbach's alpha. Int J Med Educ 2011;2:53-5.   DOI
28 Binkowitz B and Ibia E. Multiregional Clinical Trials: An Introduction From an Industry Perspective. Drug Inf J 2011;45:569-73.   DOI
29 Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother 2015;6:185-7.   DOI
30 Siering U, Eikermann M, Hausner E, et al. Appraisal tools for clinical practice guidelines: a systematic review. PLoS One 2013;8:e82915.   DOI
31 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.   DOI
32 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.   DOI
33 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.   DOI
34 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.   DOI
35 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.
36 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.   DOI
37 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.   DOI
38 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.   DOI
39 Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009;180:277-8.   DOI
40 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.