International models of investigator-initiated trials: Implications for Japan

E. L. Trimble, J. Ledermann, K. Law, T. Miyata, Chiyo Imamura, B. H. Nam, Y. H. Kim, Y. J. Bang, M. Michaels, D. Ardron, S. Amano, Y. Ando, T. Tominaga, K. Kurokawa, N. Takebe

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. Materials: In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be effective, may be applied to other regions of the world. Results: In order to increase the availability of anticancer drugs world-wide, nations including Japan should examine the benefits of increasing the number of investigator-initiated clinical trials. These trials represent one of the most effective ways to translate basic scientific knowledge into clinical practice. These trials should be conducted under GCP guidelines and include Investigational New Drug application submissions with the ultimate goal of future drug approval. Conclusions: To maximize the effectiveness of these trials, a policy to educate health care professionals, cancer patients and their families, and the public in general on the benefits of clinical trials should be strengthened. Finally, policies that expedite the clinical development of novel cancer drugs which have already been shown to be effective in other countries are needed in many nations including Japan to accelerate drug approval.

Original languageEnglish
Article numbermds168
Pages (from-to)3151-3155
Number of pages5
JournalAnnals of Oncology
Volume23
Issue number12
DOIs
Publication statusPublished - 2012 Dec

Fingerprint

Japan
Research Personnel
Clinical Trials
Drug Approval
Investigational New Drug Application
Republic of Korea
Tokyo
Pharmaceutical Preparations
Neoplasms
Industry
Guidelines
Delivery of Health Care

Keywords

  • Academic/institutional investigator-initiated clinical trials
  • Anticancer drugs
  • Good clinical practice
  • Health care policy
  • International clinical trials
  • Patient advocates

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Trimble, E. L., Ledermann, J., Law, K., Miyata, T., Imamura, C., Nam, B. H., ... Takebe, N. (2012). International models of investigator-initiated trials: Implications for Japan. Annals of Oncology, 23(12), 3151-3155. [mds168]. https://doi.org/10.1093/annonc/mds168

International models of investigator-initiated trials : Implications for Japan. / Trimble, E. L.; Ledermann, J.; Law, K.; Miyata, T.; Imamura, Chiyo; Nam, B. H.; Kim, Y. H.; Bang, Y. J.; Michaels, M.; Ardron, D.; Amano, S.; Ando, Y.; Tominaga, T.; Kurokawa, K.; Takebe, N.

In: Annals of Oncology, Vol. 23, No. 12, mds168, 12.2012, p. 3151-3155.

Research output: Contribution to journalArticle

Trimble, EL, Ledermann, J, Law, K, Miyata, T, Imamura, C, Nam, BH, Kim, YH, Bang, YJ, Michaels, M, Ardron, D, Amano, S, Ando, Y, Tominaga, T, Kurokawa, K & Takebe, N 2012, 'International models of investigator-initiated trials: Implications for Japan', Annals of Oncology, vol. 23, no. 12, mds168, pp. 3151-3155. https://doi.org/10.1093/annonc/mds168
Trimble EL, Ledermann J, Law K, Miyata T, Imamura C, Nam BH et al. International models of investigator-initiated trials: Implications for Japan. Annals of Oncology. 2012 Dec;23(12):3151-3155. mds168. https://doi.org/10.1093/annonc/mds168
Trimble, E. L. ; Ledermann, J. ; Law, K. ; Miyata, T. ; Imamura, Chiyo ; Nam, B. H. ; Kim, Y. H. ; Bang, Y. J. ; Michaels, M. ; Ardron, D. ; Amano, S. ; Ando, Y. ; Tominaga, T. ; Kurokawa, K. ; Takebe, N. / International models of investigator-initiated trials : Implications for Japan. In: Annals of Oncology. 2012 ; Vol. 23, No. 12. pp. 3151-3155.
@article{2acd31b0db0d418eb776fa69cca930c7,
title = "International models of investigator-initiated trials: Implications for Japan",
abstract = "Background: Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. Materials: In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be effective, may be applied to other regions of the world. Results: In order to increase the availability of anticancer drugs world-wide, nations including Japan should examine the benefits of increasing the number of investigator-initiated clinical trials. These trials represent one of the most effective ways to translate basic scientific knowledge into clinical practice. These trials should be conducted under GCP guidelines and include Investigational New Drug application submissions with the ultimate goal of future drug approval. Conclusions: To maximize the effectiveness of these trials, a policy to educate health care professionals, cancer patients and their families, and the public in general on the benefits of clinical trials should be strengthened. Finally, policies that expedite the clinical development of novel cancer drugs which have already been shown to be effective in other countries are needed in many nations including Japan to accelerate drug approval.",
keywords = "Academic/institutional investigator-initiated clinical trials, Anticancer drugs, Good clinical practice, Health care policy, International clinical trials, Patient advocates",
author = "Trimble, {E. L.} and J. Ledermann and K. Law and T. Miyata and Chiyo Imamura and Nam, {B. H.} and Kim, {Y. H.} and Bang, {Y. J.} and M. Michaels and D. Ardron and S. Amano and Y. Ando and T. Tominaga and K. Kurokawa and N. Takebe",
year = "2012",
month = "12",
doi = "10.1093/annonc/mds168",
language = "English",
volume = "23",
pages = "3151--3155",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "12",

}

TY - JOUR

T1 - International models of investigator-initiated trials

T2 - Implications for Japan

AU - Trimble, E. L.

AU - Ledermann, J.

AU - Law, K.

AU - Miyata, T.

AU - Imamura, Chiyo

AU - Nam, B. H.

AU - Kim, Y. H.

AU - Bang, Y. J.

AU - Michaels, M.

AU - Ardron, D.

AU - Amano, S.

AU - Ando, Y.

AU - Tominaga, T.

AU - Kurokawa, K.

AU - Takebe, N.

PY - 2012/12

Y1 - 2012/12

N2 - Background: Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. Materials: In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be effective, may be applied to other regions of the world. Results: In order to increase the availability of anticancer drugs world-wide, nations including Japan should examine the benefits of increasing the number of investigator-initiated clinical trials. These trials represent one of the most effective ways to translate basic scientific knowledge into clinical practice. These trials should be conducted under GCP guidelines and include Investigational New Drug application submissions with the ultimate goal of future drug approval. Conclusions: To maximize the effectiveness of these trials, a policy to educate health care professionals, cancer patients and their families, and the public in general on the benefits of clinical trials should be strengthened. Finally, policies that expedite the clinical development of novel cancer drugs which have already been shown to be effective in other countries are needed in many nations including Japan to accelerate drug approval.

AB - Background: Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. Materials: In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be effective, may be applied to other regions of the world. Results: In order to increase the availability of anticancer drugs world-wide, nations including Japan should examine the benefits of increasing the number of investigator-initiated clinical trials. These trials represent one of the most effective ways to translate basic scientific knowledge into clinical practice. These trials should be conducted under GCP guidelines and include Investigational New Drug application submissions with the ultimate goal of future drug approval. Conclusions: To maximize the effectiveness of these trials, a policy to educate health care professionals, cancer patients and their families, and the public in general on the benefits of clinical trials should be strengthened. Finally, policies that expedite the clinical development of novel cancer drugs which have already been shown to be effective in other countries are needed in many nations including Japan to accelerate drug approval.

KW - Academic/institutional investigator-initiated clinical trials

KW - Anticancer drugs

KW - Good clinical practice

KW - Health care policy

KW - International clinical trials

KW - Patient advocates

UR - http://www.scopus.com/inward/record.url?scp=84869801429&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84869801429&partnerID=8YFLogxK

U2 - 10.1093/annonc/mds168

DO - 10.1093/annonc/mds168

M3 - Article

C2 - 22843420

AN - SCOPUS:84869801429

VL - 23

SP - 3151

EP - 3155

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 12

M1 - mds168

ER -