2005학년도 1학기 임상연구총론 강좌를 제공하오니, 제약회사 신약개발 관계자, 병원의 임상연구자 등, 관심있는 분들의 많은 문의와 참여를 부탁드립니다.

Principles and Practice of Clinical Research

울산의대 서울아산병원 임상연구센터/임상약리학과

■ 일시 : 2005-03-24 ~2005-07-14 매주 목요일 오후 6시~9시

■ 장소 : 서울아산병원내 (참석 확정자에게 추후 통보합니다.)

■ 정원 : 30명 (Email: ksbae@amc.seoul.kr 로 자기소개를 포함한 신청을 받아 선정합니다.)

■ Certificate : 3월 24일 전에 등록되어 80%이상 출석자에게는 해당과정에 대한 certificate를
드립니다.

■ 교재 : Gallin JI. Principles and Practice of Clinical Reseach. Academic Press. 2002.

■ 진행 : US NIH CC에서 인터넷에 공개한 IPPCR 영문자막 비디오를 시청한 후 토론합니다. (Moderator: 이무송, 배균섭)

(공개된 주소 http://www.nihtraining.com/cc/ippcr/archive04f/menu.html)



1. 일자 : 03-24

Welcome and a Historical Perspective (30 minutes) / John I. Gallin, M.D.
Choosing a Research Question (30 minutes) / John I. Gallin, M.D
Measures (1 hour) / Erin McClure, Ph.D.

2. 일자 : 03-31

Unanticipated Risk in Clinical Research(1 hour) / Laura Lee Johnson
Issues in Randomization (1.5 hours) / Tamara Harris, M.D.

3. 일자 : 04-07
Overview of Hypothesis Testing (1.5 hours) / Laura Lee Johnson

4. 일자 : 04-14
Sample Size and Power (1.5 hours) / Laura Lee Johnson
Participant Selection (45 minutes) / Tamara Harris, M.D.

5. 일자 : 04-21
Using Secondary Data and Meta Analysis (45 minutes) / Tamara Harris, M.D.
Design of Epidemiologic Studies (1.5 hours)

6. 일자 : 04-28
Conceptual Approach to Survival Analysis (1.5 hours) / Laura Lee Johnson
Study Development (1 hour) / Jack Guralnik, M.D.

7. 일자 : 05-12
Opportunities for Innovation in Clinical Research: From Molecule to Medicare (1.5 hours) / Mitchell Max, M.D.
Scientific Conduct (1 hour) / Joan Schwartz, Ph.D.

8. 일자 : 05-19
Ethical Principles in Clinical Research (45 minutes) / Joan Schwartz, Ph.D
Researching an Ethics Question (45 min) / Ezekiel Emanuel, M.D.
Data and Safety Monitoring Boards (45 minutes) / Frederick Ferris, M.D.

9. 일자 : 05-26
Designing and Testing Questionnaires (45 minutes) / Jack Guralnik, M.D.
Legal Issues in Clinical Research (1 hour) / Patricia Kvochak, J.D.

10. 일자 : 06-02
Quality Control in Clinical Trials (45 minutes) / Jack Guralnik, M.D.
The Clinical Researcher and the Media (45 minutes) / John Burklow, M.S.
Product Development: Moving from the Bench to the Clinic (45 minutes) / Phillip Gomez, Ph.D., M.B.A.

11. 일자 : 06-09
Clinical Research from the Patient’s Perspective (1 hour) / Susan Butler, B.A., M.A
FDA Product Regulation (1 hour) / Kathryn Zoon, Ph.D.

12. 일자 : 06-16
Inclusion of Women and Minorities in Clinical Trials (45 minutes) / Miriam Kelty, Ph.D.
Data Management in Clinical Trials (45 minutes) / Anne Tompkins, R.N.
Human Genome Project and Clinical Research(1 hour) /Christopher Austin, M.D.

13. 일자 : 06-23
Evaluation of a Protocol Budget (1.5 hours) / Margaret Matula
Quality of Life (1 hour) / John Ware, Ph.D.

14. 일자 : 06-30
NIH Peer Review Process (1 hour) / Olivia Bartlett, Ph.D
Economic Analysis in Clinical Research (1.5 hours) / Martin Brown, Ph.D.

15. 일자 : 07-07
ProtoType and Protocol Mechanics (1 hour) / Robert Nussenblatt
Technology Transfer (1.5 hours) / Jack Spiegel, Ph.D., Bruce Goldstein

16. 일자 : 07-14
Concepts in the Management of Projects(45 minutes) / Charles Grudzinskas
Design of Case Report Forms (45 minutes) / David Mailhot, B.S.
Evaluation of Alternative and Complementary Therapies (1 hour) / Marc Blackman, M.D.


참고사이트 http://www.cc.nih.gov/researchers/training.shtml