Cancer Res Treat.  2016 Jan;48(1):20-27. 10.4143/crt.2014.317.

Current Status and Challenges of Cancer Clinical Trials in Korea

• Shim BY
• Park SH
• Lee S
• Kim JS
• Lee KE
• Kang YK
• Ahn MJ

• KMID: 2152256
• DOI: http://doi.org/10.4143/crt.2014.317

Abstract

PURPOSE
Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems.
MATERIALS AND METHODS
We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers in 56 academic hospitals.
RESULTS
The number of cancer clinical trials approved by the KFDA increased almost twofold from 2007 to 2013. The number of sponsor-initiated clinical trials (SITs) increased by 50% and investigator-initiated clinical trials (IITs) increased by almost 640%. Three hundred and forty-four clinical trials were approved by the KFDA between 2012 and 2013. At the time of the on-line survey (August 2013), 646 SITs and 519 IITs were ongoing in all hospitals. Six high volume hospitals were each conducting more than 50 clinical trials, including both SITs and IITs. Fifty-six investigators (31%) complained of the difficulties in raising funds to conduct clinical trials.
CONCLUSION
The number of cancer clinical trials in Korea rapidly increased from 2007 to 2013, as has the number of multicenter clinical trials and IITs run by cooperative study groups. Limited funding for IIT is a serious problem, and more financial support is needed both from government agencies and public donations from non-profit organizations.

Keyword

Clinical trial; Sponsor-initiated clinical trial; Investigator-initiated clinical trial

MeSH Terms

4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid
Financial Management
Financial Support
Government Agencies
Hospitals, High-Volume
Humans
Korea*
Organizations, Nonprofit
Research Personnel
United States Food and Drug Administration
4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid

Figure

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  Fig. 1. Clinicaltrials approved by Korea Food and Drug Administration (KFDA) annually.(A) Total clinicaltrials.(B) Cancer clinical trials. SIT, sponsor-initiated clinical trial; IIT, investigator-initiated clinical trial.

• 

  Fig. 2. Types of cancers in sponsor-initiated clinical trials (SITs) (A) and investigator-initiated clinical trials (IITs) (B) approved by Korea Food and Drug Administration (KFDA) in 2012 and 2013, in order of increasing number.

• 

  Fig. 3. Number of hospitals by number of clinical trials.

Reference

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