An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital

BMC Medical Research Methodology

Masayuki Yokode⁴  Toshinori Murayama⁴  Manabu Minami⁴  Takuya Miyagawa¹  Kyu-Jin Choi³  Eun-Kyung Choi²  Taichi Hatta⁴  Keiichi Narita⁴  Shiro Tanaka⁵  Soo-Youn Kim³  Eriko Sumi⁴  Ock-Joo Kim³  Jeong-Hwa Hong³  Toshiko Ito-Ihara⁴ 

[1] Program in History and Philosophy of Science, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, South Korea;Institute of Medical History and Culture, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, South Korea;Department of the History of Medicine and Medical Humanities, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-Gu, Seoul, South Korea;Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan;Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, Japan

关键词: South Korea;    Japan;    Questionnaire;    Clinical trials;    Attitude of physicians;   

Others  :  866623
DOI  :  10.1186/1471-2288-13-130

 received in 2012-07-30, accepted in 2013-10-18,  发布年份 2013

【 摘 要 】

Background

International clinical trials are now rapidly expanding into Asia. However, the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in both countries. The difference in clinical trial environment might influence the respective physicians’ attitudes and experience towards clinical trials. Therefore, we designed a questionnaire to explore how physicians conceive the issues surrounding clinical trials in both countries.

Methods

A questionnaire survey was conducted at Kyoto University Hospital (KUHP) and Seoul National University Hospital (SNUH) in 2008. The questionnaire consisted of 15 questions and 2 open-ended questions on broad key issues relating to clinical trials.

Results

The number of responders was 301 at KUHP and 398 at SNUH. Doctors with trial experience were 196 at KUHP and 150 at SNUH. Among them, 12% (24/196) at KUHP and 41% (61/150) at SUNH had global trial experience. Most respondents at both institutions viewed clinical trials favorably and thought that conducting clinical trials contributed to medical advances, which would ultimately lead to new and better treatments. The main reason raised as a hindrance to conducting clinical trials was the lack of personnel support and time. Doctors at both university hospitals thought that more clinical research coordinators were required to conduct clinical trials more efficiently. KUHP doctors were driven mainly by pure academic interest or for their desire to find new treatments, while obtaining credits for board certification and co-authorship on manuscripts also served as motivation factors for doctors at SNUH.

Conclusions

Our results revealed that there might be two different approaches to increase clinical trial activity. One is a social level approach to establish clinical trial infrastructure providing sufficient clinical research professionals. The other is an individual level approach that would provide incentives to encourage doctors to participate in and conduct clinical trials.

【 授权许可】

   
2013 Ito-Ihara et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Thiers FA, Sinskey AJ, Berndt ER: Trends in the globalization of clinical trials. Nat Rev Drug Discov 2008, 7:13-14.
• [2]International Conference on Harmonisation (ICH): Guideline for good clinical practice E6(R1). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf webcite
• [3]Ministry of Health, Labour and Welfare: Ordinance on GCP. http://law.e-gov.go.jp/htmldata/H09/H09F03601000028.html webcite
• [4]Fukuhara S, Tanabe N, Sato K, Ohashi Y, Kurokawa K: Good clinical practice in Japan before and after ICH: problems and potential impacts on clinical trials and medical practice. Int J Pharm Med 1997, 11:147-153.
• [5]Hashimoto J, Ueda E, Narukawa M: The current situation of oncology drug Lag in Japan and strategic approaches for pharmaceutical companies. Drug Inf J 2009, 43:757-765.
• [6]McCurry J: Japan unveils 5-year plan to boost clinical research. Lancet 2007, 369:1333-1336.
• [7]Ichimaru K, Toyoshima S, Uyama Y: PMDA’s Challenge to accelerate clinical development and review of new drugs in Japan. Clin Pharmacol Ther 2010, 88:454-457.
• [8]Sinha G: Japan works to shorten “drug Lag,“boost trials of new drugs. J Natl Cancer Inst 2010, 103:148-151. http://jnci.oxfordjournals.org/content/102/3/148.full.pdf webcite
• [9]Pharmaceuticals and Medical Devices Agency: Drug lag estimation FY2006-FY2009. http://www.pmda.go.jp/operations/shonin/druglag.html webcite
• [10]Ministry of Health, Labour and Welfare: The first interim assessment of New 5 yearly clinical trial activation plan. 2009. http://www.mhlw.go.jp/stf/shingi/2r9852000001f1rr-att/2r9852000001f27k.pdf webcite
• [11]Lee H, Kim CJ, Shin SG: Changes in clinical trial practice and the working environment in the Korean pharmaceutical industry since the implementation of good clinical practice. Drug Inf J 2001, 35:203-210.
• [12]Kim OJ, Park BJ, Sohn DR, Lee SM, Shin SG: Current status of the institutional review boards in Korea: constitution, operation, and policy for protection of human research participants. J Korean Med Sci 2003, 18:3-10.
• [13]Korea national enterprise for clinical trials http://www.konect.or.kr/eng/ webcite
• [14]Yanagawa H, Nishiya M, Miyamoto T, Shikishima M, Imura M, Nakanishi R, Ariuchi K, Akaishi A, Takai S, Abe S, Kisyuku M, Kageyama C, Sato C, Yamagami M, Urakawa N, Sone S, Irahara M: Clinical trials for drug approval: a pilot study of the view of doctors at Tokushima University Hospital. J Med Invest 2006, 53:292-296.
• [15]Sumi E, Murayama T, Yokode M: A survey of attitudes toward clinical research among physicians at Kyoto University Hospital. BMC Med Educ 2009, 9:75. BioMed Central Full Text
• [16]Saito K, Kodama Y, Ono S, Mutoh M, Kawashima S, Fujimura A: Current status of quality in Japanese clinical trials. Contemp Clin Trials 2005, 26:503-509.
• [17]Takita M, Narimatsu H, Tomoko M, Kishi Y, Murashige N, Hamaki T, Kodama Y, Yuji K, Tanaka Y, Kami M: Study of newspaper reports regarding clinical trials in Japan. J Clin Oncol 2009, 27:2099-2101.
• [18]Kim MJ: Comparison of the national healthcare insurance system in Japan and South Korea, through the developmental processes. Nissei Res Inst Rep 2009, 12-21. http://www.nli-research.co.jp/report/report/2008/01/repo0901-2.pdf webcite
• [19]Nomura H, Nakayama T: The Japanese healthcare system. Br Med J 2005, 331:648-649.
• [20]World Health Organization: WHO world health statistics. 2010. http://www.who.int/whosis/whostat/en/ webcite
• [21]Imamura K, Japanese Association of Pharmaceutical Medicine (JAPhMed): Recommendations on clinical research. http://japhmed.jp/english/JAP%EF%BD%88Med_eng_20091028_final_v2.pdf webcite
• [22]The Ministry of Health, Labour and Welfare of Japan: The ethics guideline for clinical studies. 2009. http://www.mhlw.go.jp/general/seido/kousei/i-kenkyu/rinsyo/dl/shishin.pdf webcite
• [23]Murayama T, Sumi E, Minami M, Itoh-Ihara T, Yokode M: An approach for the total amendment of 'ethical guidelines for clinical Studies’ in Japan-development of a systematic educational program-[abstract]. Clin Trials 2010, 7:446.
• [24]Hales G, Beveridge A, Smith D: The conflicting roles of clinicians versus investigators in HIV randomised clinical trials. Cult Health Sex 2001, 3:67-79.
• [25]Tomlin Z, Desalis I, Toerien M, Donovan JL: Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent. Health Expectin press
• [26]Rousseau DM, Sitkin SB, Burt RS, Camerer C: Not so different after all: A cross-discipline view of trust. Acad Manage Rev 1998, 23:393-404.
• [27]Hofstede G: Cultures and Organizations: Software of the Mind. London: McGraw-Hill Book Company; 1991.
• [28]Sato Y, Koyama K: Clinical research in Japan: past, present and future. Keio J Med 2010, 59:104-109.
• [29]Glass HE: The importance of medical innovation in an investigator’s decision to take part in clinical trials. Drug Inf J 2008, 42:537-543.
• [30]Glass HE, Glass JM: Latin American physicians attitudes toward participation in clinical trials: a comparison with US physicians. Pharm Med 2011, 25:87-94.
• [31]Seong SJ, Lim MS, Oak S, Lee J, Park SM, Park J, Seo JJ, Lee HW, Shin SG, Park MS, Yoon YR: Results of 2012 KoNECT certification program of the human resource project. J of Korean Soc Clin Phrmacol Ther 2012, 20:182-194.
• [32]Sackett DL, Hoey J: Why randomized controlled trials fail but needn’t: a new series is launched. Can Med Assoc J 2000, 62:1301-1302.
• [33]Garcia J, Elbourne D, Snowdon C: Equipoise: a case study of the views of clinicians involved in two neonatal trials. Clin Trials 2004, 1:170-178.
• [34]Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R: Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 1999, 52:1143-1156.