국가임상시험지원재단

● Early Phase Clinical Pharmacology Studies ? Timing, Contents, and Impact

?Early Phase Clinical Pharmacology Studies ? Timing, Contents, and Impact

In drug development process, clinical pharmacology studies contribute more than 60% of drug labeling information and the cost of doing clinical studies are increasing exponentially. 
The speaker will share many years of his clinical drug development experiences to show why/when/how the early phase Clinical Pharmacology studies are connected and provide examples of how the information generated could impact the overall clinical development program and product labeling.
In this presentation, the overall Phase 1 Clinical Pharmacology studies will be briefly introduced by describing important design elements of studies, timing of studies, and the information gained from these studies. 
The speaker will share many years of his clinical drug development experiences to show why/when/how the early phase Clinical Pharmacology studies are connected and provide examples of how the information generated could impact the overall clinical development program and product labeling.?

● How to Design Clinical Trial with Considering Statistical Methodology

Byung-Ho Nam(Herings Global)

There are several key challenging design strategy issues to consider in early phase clinical trials. First would be selecting right patients with considering appropriate biomarkers. Treatment decision including single or combination, dose, frequency, and duration would be next. Selecting right endpoints and their evaluation methods would be also challenging.
These model-based designs can solve several potential problems in the rule-based and even model-based methods.
The modified toxicity probability interval (mTPI) method is relatively new adaptive method. mTPI design uses a Bayesian statistical framework. Decisions of the mTPI are based on the posterior probabilities that reflect the relative distance between toxicity rate of each dose level to the target probability. All dose-selection decisions can be pre-calculated under the mTPI.
Dose transition pathways (DTP) is another tool for right dose selection. DTP plays a practical calibration, analysis and operational tool. The idea of DTP is to project in advance the recommended doses for subsequent cohorts depending on the information accrued.
These model-based designs can solve several potential problems in the rule-based and even model-based methods.?

1. Joseph Kim(PAREXEL)

2. Byung-Ho Nam(Herings Global) 

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

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