A Survey on Perception of Clinical Trial of Pharmaceuticals and Informed Consent in Korea

의약품 임상시험 및 피험자 동의서에 대한 인식도

  • Lee, Seong-Hee (Graduate School of Public Health, The Catholic University of Korea) ;
  • Choe, Byung-In (Clinical Research Coordinating Center of Catholic Medical Center, The Catholic University of Korea) ;
  • Kim, Chul-Min (Department of Family Medicine, The Catholic University of Korea) ;
  • Kim, Kyung-Soo (Clinical Research Coordinating Center of Catholic Medical Center, The Catholic University of Korea)
  • 이성희 (가톨릭대학교 보건대학원) ;
  • 최병인 (가톨릭중앙의료원 임상연구지원센터) ;
  • 김철민 (가톨릭대학교 의과대학 가정의학교실) ;
  • 김경수 (가톨릭중앙의료원 임상연구지원센터)
  • Received : 2009.05.22
  • Accepted : 2009.06.11
  • Published : 2009.06.30

Abstract

Background: The questionnaires were answered by the patients and their family members who visited the hospitals, the staffs in the hospitals, and the personnels who are involved with clinical trials such as the physicians, pharmacists and nurses for the purpose of surveying the cognition on clinical trial and informed consent. This study was performed in order to provide with the basic information and/or data for supporting to motivate the clinical trials by analyzing the factors affecting the difference of the cognition on each item. Method: The number of whom responded to the questionnaires was 310 in total, which was composed with 137 patients and their family members, 109 staffs in the hospitals, and 64 personnels involved with clinical trials. Result: Most of them were well acquainted with clinical trial, and knew that it is the processes to identify the safety and efficacy with the patients and it has been done in the big hospitals like university hospitals. As the results of surveying the cognition on the processes of clinical trials, most of them were known well but something was not recognized like the patients’ right to see their medical history records. While the expectation which can be obtained by participating in clinical trials was not so big, the biggest one was to get more advantageous benefits (efficacy) from clinical trial. With regard to the cognition on the informed consent, it was well understood its basic concept and procedures. The responders who participated in clinical trials before answered they regard that to conduct the clinical trial is more ethic and the mandatory process to develop the new drugs rather than what those that did not participated in the clinical trials, by 2.0 and 2.7 times, respectively. From the points of general relations considering the participation in clinical trials, the persons with diseases show more experience to participate in it, by 5.8 times, rather than those without diseases, and the persons with medication have 4.8 times more experience in participate in clinical trials than those who do not take the drugs. In addition, the persons who have participated in clinical trials showed more willingness to participate in clinical trials than those who have not participated in it. Conclusion: From the survey results by the questionnaire, considering the current circumstances that the numbers of clinical trials has been rapidly increasing, it was found and is recommended that the persons participating in clinical trials should continuously give the patients and their family members more correct and useful knowledge and information on clinical trials and at the same time that the patients should make their efforts to acquire the adequate information and their duties on clinical trials and make decision of their participation in clinical trials by themselves.

Keywords

References

  1. 한국보건산업진흥원. 선진국의 신약개발 현황. 선진국의 신약개발 현황 2006:2-6
  2. 구인회. 임상시험의 윤리적 리스크 문제 Biowave 2006;8:2-4
  3. 김옥주. 뉘른베르그 강령과 인체 실험의 윤리. 한국의료윤리교육학회 2002;5(1):18-20
  4. 윤영란과 차인준. GCP와 임상시험의 윤리적 측면. Inje Medical Journal 2002;23:50
  5. 식품의약품 안전청 발표 자료, 2009
  6. 문한림. 김훈교. 이경식. 강봉규. 송혜향. 임상 시험과 피험자 동의서에 대한 인식조사 1995;3:141-150
  7. Kim JW, Kim S-J, Chung Y-H, Kwon J-H, Lee H-J, Chung Y-J, Kim YJ, Oh D-Y, Lee S-H, Kim D-W, Im S-A, Kim T-Y et al. Cancer patient's awareness of clinical trials, perceptions on the benefit and willingness to participate:Korean perspectives. Br J cancer 2008;18: 1593-99
  8. 김양희. 암 임상연구에 참여하는 환자들의 피험자 동의서에 관한 인식조사. 연세대학교 보건대학원 2008: 30-5
  9. 식품의약품안전청 고시 제 2008-39호 의약품 임상시험관리기준
  10. 장인진. 국내 의약품 임상시험 현황과 전망. 보건산업기술동향 2006;7: 7-15
  11. 임상시험 관련자를 위한 기본교재. 식품의약품 안전청 2006
  12. Heather M. Campbell, Dennis W. Raisch, Mike R. Sather, Alissa R. Segal, Stuart R. Warren, Rupali Naik. Impact of a clinical Trials Information Handbook on Patient Knowledge, Perceptions, and Likelihood of Participation. IRB: Ethics & Human Research 2008:6-14
  13. ECRI Health Technology Assessment Information Service. Patients' Reasons for Participation in Clinical Trials and Effect of Trial Participation on Patient Outcomes 2002;74:2-38
  14. Centerwatch Research Brief. Understanding Physician Motivation and Patient Perception
  15. 백수진. 임상시험에서 피험자 보상 유형의 윤리적 문제. 생명윤리 2008;9: 1-14
  16. http://www.khanews.com/INews/data/pdf/2008/20080110/Y07-2016.pdf
  17. Primo N, Debora A, Christine C, Corinne T, Claudia M, Nora H, Lisa M, Jose G, Sharon D, Ari U, Cynthia L, David R et al. Evaluation of Factors Affecting Awareness of and Willingness to Participate in Cancer Clinical Trials. 2005;23:9282-89 https://doi.org/10.1200/JCO.2005.02.6245
  18. Robert L. Comis, John D. Miller, Carolyn R Aldige, Linda Krebs, Ellen Stoval. Public Attitudes Toward Participation in Cancer Clinical Trials. Journal of clinical oncology. 2003;21:830-5 https://doi.org/10.1200/JCO.2003.02.105
  19. Kjaergaard LL, Kruse AY, Krogsgaard K, Gluud NC, Mortensen EL, Gott-schau A, Bjerg AM. Outpatients' Knowledge about and attitude towards clinical research and randomized clinical trials. Statistician & The INFO trial group. 1998;45:439-43
  20. Robert L Comis, Carolyn R Aldige, Ellen L Stovall, Linda U Krebs, Peter J Risher, Humphrey J Taylor. A Quantitative Survey of Public Attitudes Towards Cancer Clinical Trials. Cancer Leadership Council and Oncology Nursing Society 2000: Slide 1-15
  21. Crispin Jenkinson, John S. Burton, Julia Catwright, Helen Magee Ma, Lan Hall DM Frcp, Chris Alcock Frcp, Sherwood Burge. Patient attitudes to clinical trials: development of a questionnaire and results from asthma and cancer patients 2005;8:244-252 https://doi.org/10.1111/j.1369-7625.2005.00335.x
  22. Primo N, Roger H, Nelson L, Karen K, Michael T, Derick H, Ted W, Jeanna W, Frederick J, Scott C, Robert O, Carol R "et al". Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment. Journal of Clinical Oncology 2001;19:1728-1733 https://doi.org/10.1200/JCO.2001.19.6.1728
  23. Jennifer L. Kelsey, Alice S. Whittemore, Alfred S. Evans, W. Douglas Thompson. Methods in observational Epidemiology 1996;26:244-67
  24. 김규성. 표본의 대표성과 추정의 효율성. 조사연구 2005;6:39-62
  25. 신영수, 안윤옥. 의학연구방법론 2008: 157-171