clinical-trials-臨床試驗方案-在線瀏覽
2024-09-04 17:46本頁面
【正文】 a parison CONTROL group ? Must have method to measure intervention ? Focus on unknowns: effect of medication ? Must be done before medication is part of standard of care ? Conducted early in the development of therapies NY/VI AETC Core Components of Clinical Trials ? Must review existing scientific data amp。 ethical science ? Control for any potential biases ? Most study medications, procedures, and/or other interventions NY/VI AETC The Possible World of Clinical Trial Designs ? Randomized/blinded trial ? Randomized/double blinded trial ? Nonrandomized concurrent controlled trial ? Placebo trial ? Historical controlled trial ? Crossover Trial ? Withdrawal trial NY/VI AETC Simplified ? Randomized: Schemes used to assign participant to one group o Ex: Every 3 gets higher dose ? Nonrandomized: All with Hep. C = cases。 medicine vs. surgery。 power calculations ? Plan re: potential biases ? Plan re: handling of attrition/loss to follow up NY/VI AETC Study Participant Recruitment ? Identify eligible participants ? Explain study ? Provide informed consent ? Reassess eligibility ? Assign to one group Participants should be told: ? May have side effects (adverse effects) ? Time mitment ? Benefits amp。 identify SE ? Phase II: Rx/tx given to larger group [100300] to confirm effectiveness, monitor SE, amp。 pare it to other monly used txs amp。 SE from long term use. NY/VI AETC Summary of Phases IIII Subs. Length Purpose % Drugs Successfully Tested Phase I 20 – 100 Several months Mainly Safety 70% Phase II Up to several 100 Several months 2 yrs. Short term safety。 effectiveness 2530% NY/VI AETC Ethics of Clinical Trials: Protection of Participants 3 ethical principles guide clinical research: ? Respect for Persons: Treatment of person as autonomous ? Beneficence: Issue re: potential conflict between good of society vs. individual ? Justice: Treatment of all fairly amp。 risks NY/VI AETC Ethical Norms of Clinical Trials Sound study designs take into account: ? Randomization or sharing of risks ? Proper use of placebo ? Processes to monitor safety of rx/tx ? Competent investigators ? Informed consent ? Equitable selection of participants ? Compensation for study related injuries NY/VI AETC Ethical Issues: Protection of Human Subjects ? Rely on integrity of Investigator but outside groups also have oversight ? Participants’ rights protected by Institutional Review Boards [IRBs] o An IRB is defined as: any board, mittee or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects NY/VI AETC Human Subjects’ Protection IRB responsible for such tasks: ? Review
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