clinical-trials-臨床試驗(yàn)方案(參考版)
2025-07-28 17:46本頁(yè)面
【正文】 Take Home Message ? Clinical trials often yield important results that affect health and well being ? Must follow guidelines amp。 poorly conducted study (Ex: Tuskegee Study amp。 what occurs? ? What happens after study is over? ? How results will be disseminated? NY/VI AETC The Impact of Studies ? Some clinical trials have been critical to patient health amp。 incentives ? Support ? Others?? Why Some Do Not? ? Mistrust of studies ? Do not want to be “guinea pig” ? Do not meet criteria ? Cannot give up time for study visits ? Barriers: lang., distance NY/VI AETC Taking Part in Research Studies: Questions to Ask ? What is study about? ? What are the goals? ? Study sponsor? ? Participant input into protocols? ? Inclusion criteria? ? Benefits amp。 follow these groups NY/VI AETC Inclusion in Clinical Trials ? Historically women were excluded if of reproductive age (ages 1845) ? Fear of harm to potential unborn child ? In essence, excluded MAJORITY of women ? New guidelines eliminates this stipulation NY/VI AETC Issues in Clinical Trials: Use of Placebo Trials On international realm, 1999 “Declaration of Helsinki” revised to address use of placebos: ? Placebos not ethical in virtually all studies that involve diseases with PROVEN tx ? Remain ethical in trials where no proven tx ? Revisions due to controversy over use of placebos in attempting to find easy/cheap way to reduce HIV perinatal transmission ? 1998 study in Ivory Coast, Uganda, amp。 minorities in clinical studies ? New guidelines stipulate that: o Women amp。 II trials NY/VI AETC Informed Consent: A Part of Human Subject Protection Objectives of Informed Consent To Ensure: ? Voluntariness ? Comprehension ? Information To Demonstrate That: ? Person freely gave consent to participate ? Consent given by a petent person ? Person has been given all information ? Person knows this is research – not treatment NY/VI AETC Components of Informed Consent ? Must Include the Following Information: ? Why research being done? ? What researchers want to acplish ? What will be done and for how long ? Risks amp。 implemented ? Latest additions: Year 2022 President Clinton amp。 injury should be avoided ? No expectation that death/disabling injury will occur from the experiment ? Risk vs. benefit ? Protect subjects against injury, disability, or death ? Only scientifically qualified persons to be involved ? Subject can terminate her/his involvement NY/VI AETC Historical Minute: Origin of IRBs amp。 results not obtainable by other means ? Experiment should be based upon prior animal studies ? Physical amp。 proper protection of subjects ? Issue written notice of approval/disapproval to the Investigator ? Review and respond to proposed protoco
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