| Current State and Future Improvement of the Elderly Participation in Clinical Trials |
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Sun Wook Kim, Hee Won Jung, Miran Park, Jae Yong Chung, Keun Wook Lee, Jee Hyun Kim, Jong Seok Lee, Kwang Il Kim, Cheol Ho Kim |
1Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. kikim907@snu.ac.kr
2Clinical Trials Center, Seoul National University Bundang Hospital, Seongnam, Korea.
3Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul, Korea.
4Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. |
| 노인의 임상시험 참여에 대한 현황과 향후 발전 방향 : 임상시험 전문가를 대상으로 한 설문조사 분석 |
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김선욱1⦁정희원1⦁박미란2⦁정재용2,3⦁이근욱1,2,4⦁김지현1,4⦁이종석1,2,4⦁김광일1,4⦁김철호1,4 |
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서울대학교 의과대학 내과학교실1, 분당서울대학교병원 임상시험센터2, 서울대학교 의과대학 임상약리학교실3, 분당서울대학교병원 내과 |
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| Abstract |
BACKGROUND
Clinical trials are widely used to approve the efficacy and discover adverse reactions of new drugs. However, there has been much concern about the unjustified exclusion of the older adults in clinical trials. The purpose of this study was to assess ageism in clinical trials and to find solution to any discovered discrimination.
METHODS
An online questionnaire was completed by 1,650 experts including doctors, pharmaceutical staff, and contract research organization members. An offline inquiry was conducted by 250 experienced professors from a single tertiary hospital and other allied professions. The questions covered the current state of elderly participation, possible reasons for under-representation, and plans for its solution.
RESULTS
Among 1,900 subjects, 246 (12.9%) individuals completed the survey. We excluded the six subjects who did not answer more than 10 questions, and analyzed the remaining 240 respondents. They agreed that there are tendencies to exclude the aged from clinical trials (69.2%), and that under-representation would cause difficulties for doctors and geriatric patients. Most people (84.6%) thought that treating older adults with the results from trials which exclude aged participants is inappropriate. Because respondents had difficulties explaining the trial process and obtaining informed consent, they thought establishing a geriatric clinical trial team would be highly effective. Experts also believed that financial inducements and legal regulations are required to increase elderly enrollment.
CONCLUSION
Because the elderly have a unique physiology, the participation of older adults in clinical research is indispensable for verifying efficacy and determining potential adverse reactions. Consequently, clinical research professionals should be concerned about the participation of older subjects, and the authorities must begin to care about age discrimination in research fields. |
| Key Words:
Aged, Clinical trial, Ethics Committees, Drug approval |
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