clinical-trials-臨床試驗方案(存儲版)
【正文】 f steps: – 1: Experiments in the laboratory – 2: Once deemed safe, go through 14 phases NY/VI AETC Phases of Clinical Trials ? Phase I: Small group [2080] for 1st time to evaluate safety, determine safe dosage range amp。 all equally share benefits amp。 implemented ? Latest additions: Year 2022 President Clinton 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。 Take Home Message ? Clinical trials often yield important results that affect health and well being ? Must follow guidelines 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。 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。 mainly effectiveness 33% Phase III 100s – several 1000 14 yrs. Safety, dosage amp。 low dose vs. high dose ? Specific inclusion/exclusion criteria ? Sample size amp。 Hypothesis Testing ? Ex: Cohort Studies, Case Control Studies ? Clinical Trials ? Ex: Investigation of Treatment/Condition ? Ex: Drug Trials NY/VI AETC The Different Study Designs ? Casecontrol ? Cohort ? Case Reports ? Case Series ? Outes Based: ? Survey Research: Quality of Life Questionnaires Decision analysis Polls Economic Analysis Surveys ? Meta Analyses ? Survival Analysis ? Randomized Clinical Trial NY/VI AETC Basic Research Terminology ? Retrospective: Refers to time of data collection ? Prospective: Refers to time of data collection ? Case Control Study: Persons w/ disease amp。 contrasts made between groups ? The observed data col
電大資料相關(guān)推薦
鄂ICP備17016276號-1