국가임상시험지원재단

Investigator-Initiated Trial (IIT) is a clinical trial initiated and sponsored by non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations. In IITs, the investigator acts as a sponsor-investigator. The individual investigator’s role in these trials is to plan, design, conduct, monitor, manage data, prepare reports, and provide oversight for the study.
Well-conducted IITs can make everybody involved win. IITs represent an effective means of collecting robust postmarket data that could benefit the medical community as a whole. In IITs, physicians are given an opportunity to use and develop an expertise in a new drug, and can contribute to the accumulation of new knowledge. Patients enrolled in these studies will be afforded excellent long-term follow-up, given the importance of long-term data to such studies. Perhaps most important, medical industry, regulatory agencies, physicians, and patients will be given extensive data on the efficacy and safety of new drugs and devices, thus impacting future development, approval, payment, and the use of these devices.
The trial request must be initiated by the investigator and not by the company. It has to be a spontaneous, unsolicited request. The request, in the form of a concept note, is evaluated based on objective criteria such as credentials of the investigator, need for such a study (meets unmet medical need or fills a gap in medical literature), quality of design of the study, and cost-effectiveness (needs to be reasonable enough to fit into the budget).
Well-conducted IITs can make everybody involved win. IITs represent an effective means of collecting robust postmarket data that could benefit the medical community as a whole. In IITs, physicians are given an opportunity to use and develop an expertise in a new drug, and can contribute to the accumulation of new knowledge. Patients enrolled in these studies will be afforded excellent long-term follow-up, given the importance of long-term data to such studies. Perhaps most important, medical industry, regulatory agencies, physicians, and patients will be given extensive data on the efficacy and safety of new drugs and devices, thus impacting future development, approval, payment, and the use of these devices.? 

Young-suk Lim (ASAN Medical Center, Korea) 

상기 과정은 직능별, 단계별 인정가능시간이 상이하며 인정가능시간은 다음의 별표를 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

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