Clinical trials and approval of anti-cancer agents

Masaru Iwasaki, Shiro Hinotsu, Jun Katsura

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Nowadays, drug development requires large-scale studies to show the real clinical benefit for the patients, which means recruiting a sufficient number of patients, even internationally. As global studies enable simultaneous delivery of new drugs and sharing of safety information around the world, multinational studies now account for around 20% of Japanese clinical studies. Until recently, drug development has been centered in Western countries, but interest in Asian regions has increased. In this environment, one important factor in drug development is ethnicity. Various cancers show regional patterns in their incidence, and some (such as liver cancer and gastric cancer) show high incidences in Asian countries. Ethnic factors including genetic differences, such as the CYP drug-metabolizing enzymes in the liver and gene mutations, may result in different drug responses in terms of efficacy and safety. Examples of ethnic differences in drug responses were seen with gefitinib, which showed a different efficacy data, and with sunitinib, showing a clearly different toxicity profile between the West and Asia. Therefore, ethnic differences need to be taken into account in the early phase of drug development, and Asian countries need to be involved early in clinical development. Asian collaboration among physicians and networks of specialists is also important, and there is good potential for successful establishment of the infrastructure needed for collaborative clinical trials. Establishment of a so-called third development center in Asian countries that will complement the USA and European centers is highly desired.

Original languageEnglish
Article numberhyq129
JournalJapanese Journal of Clinical Oncology
Volume40
Issue numberSUPPL. 1
DOIs
Publication statusPublished - Sep 2010
Externally publishedYes

Fingerprint

Clinical Trials
Pharmaceutical Preparations
Neoplasms
Stomach Neoplasms
Safety
Information Dissemination
Incidence
Liver Neoplasms
Physicians
Mutation
Liver
Enzymes
Genes

Keywords

  • Academic network
  • Anti-cancer agents
  • Asian study
  • Ethnic factors
  • Global development

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

Clinical trials and approval of anti-cancer agents. / Iwasaki, Masaru; Hinotsu, Shiro; Katsura, Jun.

In: Japanese Journal of Clinical Oncology, Vol. 40, No. SUPPL. 1, hyq129, 09.2010.

Research output: Contribution to journalArticle

Iwasaki, Masaru ; Hinotsu, Shiro ; Katsura, Jun. / Clinical trials and approval of anti-cancer agents. In: Japanese Journal of Clinical Oncology. 2010 ; Vol. 40, No. SUPPL. 1.
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