국가임상시험지원재단

● A consideration on Implementing E17 Guidance in Clinical Development

Akira Wakana(MSD)

The E17 guidance was issued in Japan.  We have an internal taskforce team in the company to apply the guidance for future clinical development.  The team consists of various functions including clinical science, regulatory affairs, biostatistics and clinical operation to discuss the possible issues in each functional area.  One of the important topics is how to evaluate the study results based on the guidance.  The current practice to analyse and interpret results from global clinical trials in Japan focuses on Japanese subpopulation after the significant results are observed in overall population.  Currently, it is important to ensure a point estimate of treatment difference in Japanese subpopulation is in the same direction as that of overall population to claim consistency.  The new guidance may have some impact on evaluating the results, by using the concept of pooled region or subpopulation.  We will introduce some points discussed in the team.

● Facing ICH-E17 in North East Asia : Academic Perspective

In Jin Jang(Seoul National University Hospital)

MRCT will provide better evidences for drug approval in each region. The intrinsic and extrinsic factors important to the drug development program, should be identified so that the potential impact of these factors could be examined in the exploratory phases before the design of confirmatory MRCTs. The early phase exploratory MRCTs should gather scientific data regarding the impact of extrinsic and intrinsic factors on PK, PK/PD and/or other drug properties. North East Asian regions including Korea, Japan and China are good candidate for pooling due to similarities in pharmacogenetics, clinical practice and so on but diversities still exist within the regions. The role of academia is to provide basic data and criteria for evaluation of ethnic sensitivities. Academia also have to install future tools like big data and ICT technology for clinical trials. The academic hospitals of this region are also trying to establish network to share experience and collaborate in specific therapeutic area. Many academic sites in this region have successfully established infrastructures for high quality and efficiency in clinical trials.

● New Regulatory Dynamics in China

Hwei-Gene Wang(BMS)

Opdivo (nivolumab) was the first PD(L)-1 inhibitor approved in China. This ranked as one of the fastest BLA approvals by the agency. With this approval, it heralded a new era of Immuno-oncology treatment in China. Through the journey of Opdivo development and regulatory approval in 2L non-small cell lung cancer, the rapidly evolving regulatory reform and the exciting new dynamics in China will be shared. 

2. In Jin Jang(Seoul National University Hospital)

3. Hwei-Gene Wang(BMS) 

상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

(제5조 관련)