clinical-trials-临床试验方案

1、2021/3/11 NY/VI AETC Understanding Clinical Trials Developed by Sara Back, NP Bronx-Lebanon Hospital Center 2021/3/11 NY/VI AETC Overview Purpose of Research Studies Classifications of Epidemiological Research Basic Research Terminology Features of Clinical Trials Design/Protocol Phases of a Study E

2、thics Protection of Participants Contributions of Clinical Trials Participating in a Trial Conclusion others = controls Study design - instructions Participants do not know if in experimental or control group Participants AND staff do not know group assignment Inactive pill w/ no therapeutic value 2

3、021/3/11 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 mainly effectiveness 33% 100s several 1000 1-4 yrs.Safety, dosage

4、 & effectiveness 25-30% 2021/3/11 NY/VI AETC Ethics of Clinical Trials: Protection of Participants 3 ethical principles guide clinical research: Treatment of person as autonomous Issue re: potential conflict between good of society vs. individual Treatment of all fairly & all equally share benefits

5、& risks 2021/3/11 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 relate

6、d injuries 2021/3/11 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 oAn IRB is defined as: any board, committee or other group formally designated by an

7、 institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects 2021/3/11 NY/VI AETC Human Subjects Protection Review research to ensure that potential benefits outweigh risks Develop and issue written procedures Review research fo

8、r risk/benefit analysis & proper protection of subjects Issue written notice of approval/disapproval to the Investigator Review and respond to proposed protocol changes submitted by the Investigator 2021/3/11 NY/VI AETC Human Subjects Protection Review reports of deaths, and serious and unexpected a

9、dverse events received from the Investigator Conduct periodic continuing review of the study, study risks, selection of subjects, privacy of subjects, confidentiality of data, and the consent process 2021/3/11 NY/VI AETC Historical Minute: Origin of IRBs & Human Subject Code Attention to protecting

10、participants began after WWII w/ the Nuremberg Trials (1947) Out of those trials, key points were codified 2021/3/11 NY/VI AETC Historical Minute: 10 Key Points Voluntary informed consent Experiment must be for the good of society, & results not obtainable by other means Experiment should be based u

11、pon prior animal studies Physical & mental suffering & 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

12、her/his involvement 2021/3/11 NY/VI AETC Historical Minute: Origin of IRBs & Human Subject Codes Since 1947, additional subject protection requirements developed & implemented Latest additions: Year 2000 - President Clinton & DHHS Secretary Shalala announced additional study requirements related to:

13、 informed consenttraining req. adverse events conflict of interest civil monetary penalties improved monitoring of Phase I & II trials 2021/3/11 NY/VI AETC Informed Consent: A Part of Human Subject Protection Objectives of Informed Consent To Ensure: Voluntariness Comprehension Information To Demons

14、trate That: Person freely gave consent to participate Consent given by a competent person Person has been given all information Person knows this is research not treatment 2021/3/11 NY/VI AETC Components of Informed Consent Must Include the Following Information: Why research being done? What resear

15、chers want to accomplish What will be done and for how long Risks & benefits of trial Other treatments available Can withdraw from trial whenever desire Compensation for unexpected injuries 2021/3/11 NY/VI AETC Vulnerable Populations Groups thought not to have autonomy to give informed consent: chil

16、dren mentally impaired, individuals with dementia Prisoners Who may be unduly influenced to participate: students subordinates pregnant women (actually, the fetuses) patients (care-giver vs. researcher) 2021/3/11 NY/VI AETC Vulnerable Populations To safe guard these groups, special requirements such

17、 as: Only parent can consent for minor Consents must be in subjects native lang. Prisoners: only some types of research allowed 2021/3/11 NY/VI AETC Inclusion in Clinical Trials Guidelines that require inclusion of women & minorities in clinical studies New guidelines stipulate that: oWomen & minori

18、ties are to be included in all human subject research oThey are to be included in Phase III trials to allow sufficient power to note differences oCost cannot be a barrier oOutreach activities must take place to include & follow these groups 2021/3/11 NY/VI AETC Inclusion in Clinical Trials Historica

19、lly women were excluded if of reproductive age (ages 18-45) Fear of harm to potential unborn child In essence, excluded MAJORITY of women New guidelines eliminates this stipulation 2021/3/11 NY/VI AETC Issues in Clinical Trials: Use of Placebo Trials On international realm, 1999 “Declaration of Hels

20、inki” 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 st

21、udy in Ivory Coast, Uganda, & Thailand: HIV+ pregnant women given either placebo or shorter course of AZT 2021/3/11 NY/VI AETC Participation in Clinical Trials Give back to society Exhausted all other txs Health care services Payment & incentives Support Others? Mistrust of studies Do not want to be

22、 “guinea pig” Do not meet criteria Cannot give up time for study visits Barriers: lang., distance 2021/3/11 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 & risks Is t

23、here an incentive? How protected from harm? What is required: # study visit & what occurs? What happens after study is over? How results will be disseminated? 2021/3/11 NY/VI AETC The Impact of Studies Some clinical trials have been critical to patient health & provision of health care For instance: o