clinical-trials-臨床試驗方案-閱讀頁
2025-08-09 17:46本頁面
【正文】 research to ensure that potential benefits outweigh risks ? Develop and issue written procedures ? Review research for risk/benefit analysis amp。 Human Subject Code ? Attention to protecting participants began after WWII w/ the Nuremberg Trials (1947) ? Out of those trials, key points were codified NY/VI AETC Historical Minute: 10 Key Points ? Voluntary informed consent ? Experiment must be for the good of society, amp。 mental suffering amp。 Human Subject Codes ? Since 1947, additional subject protection requirements developed amp。 DHHS Secretary Shalala announced additional study requirements related to: informed consent training req. adverse events conflict of interest civil moary penalties improved monitoring of Phase I amp。 benefits of trial ? Other treatments available ? Can withdraw from trial whenever desire ? Compensation for unexpected injuries NY/VI AETC Vulnerable Populations Groups thought not to have autonomy to give informed consent: ? children ? mentally impaired, individuals with dementia ? Prisoners OR Who may be unduly influenced to participate: ? students ? subordinates ? pregnant women (actually, the fetuses) ? patients (caregiver vs. researcher) NY/VI AETC Vulnerable Populations To safe guard these groups, special requirements such as: ? Only parent can consent for minor ? Consents must be in subject’s native lang. ? Prisoners: only some types of research allowed NY/VI AETC Inclusion in Clinical Trials ? NIH Revitalization Act of 1993: Guidelines that require inclusion of women amp。 minorities are to be included in all human subject research o They are to be included in Phase III trials to allow sufficient power to note differences o Cost cannot be a barrier o Outreach activities must take place to include amp。 Thailand: HIV+ pregnant women given either placebo or shorter course of AZT NY/VI AETC Participation in Clinical Trials Why Some Participate: ? Give back to society ? Exhausted all other txs ? Health care services ? Payment amp。 risks ? Is there an incentive? ? How protected from harm? ? What is required: study visit amp。 provision of health care ? For instance: o Protocol 076: ? HIV perinatal transmission o 1st trial of AZT o Various cancer treatments o Development of other HIV related medications like PIs NY/VI AETC The Impact of Studies Other clinical trials have not been as successful for a variety of reasons: ? Medications did not work as in laboratory ? Loss to FollowUp of too many patients ? Harmful substance ? Uhical amp。 recent Gene Replacement Study) NY/VI AETC Conclusions amp。 protocol ? Must ensure wellbeing of participant ? Clinical trials are susceptible to human error either on part of investigator or patient ? Research is soft science
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