국가임상시험지원재단

● Why Adaptive Clinical Trials in Oncology Drug Development?

Hanlim Moon(CUREnCARE Research)

Oncology drug development requires high-quality evidence and a long period of development with conventional design of trials, which was demanded by regulatory guidelines until recently. The standard approach to generating this evidence has become more expensive and challenging to execute while newly discovered agents have better possibility to go through a short-cut by nature of those, such as biomarker targeted and immune mechanism.
In order to know how to best use adaptive design in oncology clinical devlopment, it will be very important to understand the definition, advantage, limitation, methods, success cases and practical consideration to operate. General overview of the adaptive design will be explained in this session.
In order to know how to best use adaptive design in oncology clinical devlopment, it will be very important to understand the definition, advantage, limitation, methods, success cases and practical consideration to operate. General overview of the adaptive design will be explained in this session. ?

● Benchmark and Ongoing Adaptive Trials in Oncology

Jee Hyun Kim(Seoul National University Bundang Hospital)

Next generation sequencing and comprehensive genomic profiling enabled development of novel therapeutics based on better molecular characterization of tumors in oncology. However, developing new drugs for individual molecular subtypes in oncology became more cost and resource consuming, necessitating a next generation clinical trial design incorporating testing and targeting of multiple molecular markers in a flexible protocol.  I-SPY2 is a successful example of a platform trial where multiple experimental treatments are compared to common standard control, in a neoadjuvant setting in breast cancer, where pathological compete response was used as surrogate endpoint. Patients were screened for biomarker (consisting of hormone receptor, HER2, and 70 gene assay) and adaptively randomized to standard or experimental regimen. Experimental arm was considered successful if a Bayesian predictive probability of success in a phase 3 trial is 85% or more, and ‘graduates’ whereas experimental arm fails if probability of success is less than 10% for all 10 biomarker signature. I-SPY2 enabled fast screening of novel treatment with small number of patients, making fast decisions whether to develop further into phase Ⅲ trials or not.
In the meeting, successful examples of novel treatments which ‘graduated’ I-SPY2 trial will be introduced, as well as other case studies of basket and umbrella trials in oncology.
In the meeting, successful examples of novel treatments which ‘graduated’ I-SPY2 trial will be introduced, as well as other case studies of basket and umbrella trials in oncology.

1. Hanlim Moon(CUREnCARE Research)

2. Jee Hyun Kim(Seoul National University Bundang Hospital) 

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)