Skip to main content
Erschienen in: BMC Medical Research Methodology 1/2013

Open Access 01.12.2013 | Research article

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

verfasst von: Toshiko Ito-Ihara, Jeong-Hwa Hong, Ock-Joo Kim, Eriko Sumi, Soo-Youn Kim, Shiro Tanaka, Keiichi Narita, Taichi Hatta, Eun-Kyung Choi, Kyu-Jin Choi, Takuya Miyagawa, Manabu Minami, Toshinori Murayama, Masayuki Yokode

Erschienen in: BMC Medical Research Methodology | Ausgabe 1/2013

Einloggen, um Zugang zu erhalten

Abstract

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.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Zurück zum Zitat Thiers FA, Sinskey AJ, Berndt ER: Trends in the globalization of clinical trials. Nat Rev Drug Discov. 2008, 7: 13-14. 10.1038/nrd2441.CrossRef Thiers FA, Sinskey AJ, Berndt ER: Trends in the globalization of clinical trials. Nat Rev Drug Discov. 2008, 7: 13-14. 10.1038/nrd2441.CrossRef
4.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 10.1177/009286150904300613.CrossRef 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. 10.1177/009286150904300613.CrossRef
6.
Zurück zum Zitat McCurry J: Japan unveils 5-year plan to boost clinical research. Lancet. 2007, 369: 1333-1336. 10.1016/S0140-6736(07)60615-1.CrossRefPubMed McCurry J: Japan unveils 5-year plan to boost clinical research. Lancet. 2007, 369: 1333-1336. 10.1016/S0140-6736(07)60615-1.CrossRefPubMed
7.
Zurück zum Zitat 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. 10.1038/clpt.2010.190.CrossRefPubMed 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. 10.1038/clpt.2010.190.CrossRefPubMed
11.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat 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. 10.2152/jmi.53.292.CrossRefPubMed 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. 10.2152/jmi.53.292.CrossRefPubMed
15.
Zurück zum Zitat Sumi E, Murayama T, Yokode M: A survey of attitudes toward clinical research among physicians at Kyoto University Hospital. BMC Med Educ . 2009, 9: 75-10.1186/1472-6920-9-75.CrossRefPubMedPubMedCentral Sumi E, Murayama T, Yokode M: A survey of attitudes toward clinical research among physicians at Kyoto University Hospital. BMC Med Educ . 2009, 9: 75-10.1186/1472-6920-9-75.CrossRefPubMedPubMedCentral
16.
Zurück zum Zitat 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. 10.1016/j.cct.2004.09.004.CrossRefPubMed 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. 10.1016/j.cct.2004.09.004.CrossRefPubMed
17.
Zurück zum Zitat 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. 10.1200/JCO.2008.21.3967.CrossRefPubMed 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. 10.1200/JCO.2008.21.3967.CrossRefPubMed
19.
Zurück zum Zitat Nomura H, Nakayama T: The Japanese healthcare system. Br Med J. 2005, 331: 648-649. 10.1136/bmj.331.7518.648.CrossRef Nomura H, Nakayama T: The Japanese healthcare system. Br Med J. 2005, 331: 648-649. 10.1136/bmj.331.7518.648.CrossRef
23.
Zurück zum Zitat 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- 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.
Zurück zum Zitat 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. 10.1080/136910501750035680.CrossRef 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. 10.1080/136910501750035680.CrossRef
25.
Zurück zum Zitat 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 Expect. in press 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 Expect. in press
26.
Zurück zum Zitat 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. 10.5465/AMR.1998.926617.CrossRef 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. 10.5465/AMR.1998.926617.CrossRef
27.
Zurück zum Zitat Hofstede G: Cultures and Organizations: Software of the Mind. 1991, London: McGraw-Hill Book Company Hofstede G: Cultures and Organizations: Software of the Mind. 1991, London: McGraw-Hill Book Company
28.
Zurück zum Zitat Sato Y, Koyama K: Clinical research in Japan: past, present and future. Keio J Med. 2010, 59: 104-109. 10.2302/kjm.59.104.CrossRefPubMed Sato Y, Koyama K: Clinical research in Japan: past, present and future. Keio J Med. 2010, 59: 104-109. 10.2302/kjm.59.104.CrossRefPubMed
29.
Zurück zum Zitat 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. 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.
Zurück zum Zitat Glass HE, Glass JM: Latin American physicians attitudes toward participation in clinical trials: a comparison with US physicians. Pharm Med. 2011, 25: 87-94. 10.1007/BF03256850.CrossRef Glass HE, Glass JM: Latin American physicians attitudes toward participation in clinical trials: a comparison with US physicians. Pharm Med. 2011, 25: 87-94. 10.1007/BF03256850.CrossRef
31.
Zurück zum Zitat 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. 10.12793/jkscpt.2012.20.2.182.CrossRef 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. 10.12793/jkscpt.2012.20.2.182.CrossRef
32.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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. 10.1191/1740774504cn020xx.CrossRefPubMed 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. 10.1191/1740774504cn020xx.CrossRefPubMed
34.
Zurück zum Zitat 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. 10.1016/S0895-4356(99)00141-9.CrossRefPubMed 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. 10.1016/S0895-4356(99)00141-9.CrossRefPubMed
Metadaten
Titel
An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital
verfasst von
Toshiko Ito-Ihara
Jeong-Hwa Hong
Ock-Joo Kim
Eriko Sumi
Soo-Youn Kim
Shiro Tanaka
Keiichi Narita
Taichi Hatta
Eun-Kyung Choi
Kyu-Jin Choi
Takuya Miyagawa
Manabu Minami
Toshinori Murayama
Masayuki Yokode
Publikationsdatum
01.12.2013
Verlag
BioMed Central
Erschienen in
BMC Medical Research Methodology / Ausgabe 1/2013
Elektronische ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-13-130

Weitere Artikel der Ausgabe 1/2013

BMC Medical Research Methodology 1/2013 Zur Ausgabe