clinical-trials-臨床試驗(yàn)方案-文庫(kù)吧
2025-07-10 17:46 本頁(yè)面
【正文】 period. NY/VI AETC Historical Minute First “Clinical Trials” ? Clinical Trials have a long history – even if not acknowledged as Clinical trials ? Formal record of clinical trials dates back to the time of the “Trialists”: ? Dr. Van Helmont’s proposal for a therapeutic trial of bloodletting for fevers [1628] ? Dr. Lind’s, a ship surgeon, trial of oranges amp。 limes for scurvy [1747] NY/VI AETC Historical Minute First “Clinical Trials” Historical Highlights of Drug Trials ? 1909: Paul Ehrlich Arsphenamine ? 1929: Alexander Fleming Penicillin ? 1935: Gerhard Domagk Sulfonamide ? 1944: Schatz/Bugie/Waksman – Streptomycin ? By 1950, the British Medical Res. Council developed a systematic methodology for studying amp。 evaluating therapeutic interventions NY/VI AETC Core Components of Clinical Trials ? Involve human subjects ? Move forward in time ? Most have 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。 build on that knowledge ? Test a certain hypothesis ? Study protocol must be built on sound 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。 others = controls ? Protocol: Study design instructions ? Blinded: Participants do not know if in experimental or control group ? Double Blinded: Participants AND staff do not know group assignment ? Placebo: Inactive pill w/ no therapeutic value NY/VI AETC Components of Clinical Trial Protocols ? Investigating two or more conditions so have two(+) groups ? Ex: drug vs. placebo。 medicine vs. surgery。 low dose vs. high dose ? Specific inclusion/exclusion criteria ? Sample size amp。 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。 risks ? May withdraw at any time ? Enrollment 100% voluntar
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