The Ethical Issues of Clinical Trials
The Ethical Issues of Clinical Trials
Published on 7 April 2021
ON
Oana Nuta
Oana's Personal GalleryTranscript
- 00:01
- The Ethical Issues of Clinical Trials
- 00:19
- Informed consent
- 00:26
- rights risks benefits
- 00:33
- voluntary participation
- 00:34
- purpose of research
- 00:36
- risk-benefit ratio
- 00:37
- procedures
- 00:44
- coercion undue influence
- 00:47
- Informed consent
- 00:49
- Coercive Medical Research
- 00:51
- 1950s-1970s
- 00:57
- 90%
- 01:09
- 33
- 01:11
- 153
- 01:20
- -radioactive isotopes -dioxins
- 01:42
- Inadequate understanding of the nature of research
- 01:45
- research
- 01:45
- treatment
- 01:57
- early-phase
- 01:57
- transfer in cancer and HIV trials:
- 02:01
- early-phase
- 02:01
- transfer in cancer and HIV trials:
- 02:01
- 40%
- 02:07
- early-phase
- 02:13
- early-phase
- 02:13
- transfer in cancer and HIV trials:
- 02:13
- 40%
- 02:13
- early-phase
- 02:13
- transfer in cancer and HIV trials:
- 02:13
- 40%
- 02:15
- Language barriers
- 02:22
- Research involving children
- 02:26
- legal guardian consent is mandatory
- 02:29
- child assent when child is 7+ years old
- 02:45
- BENEFITS
- 02:45
- RISKS
- 02:56
- Subject payment
- 03:01
- varies depending on country & study
- 03:07
- social & behavioural research: $50
- 03:10
- phase I trial: $100/day
- 03:18
- enhances participation in clinical trials
- 03:28
- diverse subject pool
- 03:37
- Jeopardized voluntary decision-making?
- 03:39
- undue inducement bias exploitation
- 03:45
- Undue inducement
- 03:60
- 500
- 03:60
- 500
- 03:60
- 500
- 03:60
- 500
- 04:10
- little empirical evidence
- 04:16
- motivators for participation in placebo-controlled trials:
- 04:24
- personal health benefits
- 04:25
- helping other patients
- 04:26
- contributing to scientific knowledge
- 04:38
- Volunteers from lower socioeconomic status
- 04:44
- high-risk BUT large incentives trials
- 04:47
- low-income minority men
- 04:53
- enrolment bias
- 04:58
- Exploitation
- 04:58
- Subject payment
- 04:59
- Exploitation
- 05:10
- The Surfaxin Trial
- 05:12
- infant respiratory distress syndrome
- 05:14
- conducted in 2000, in Bolivia
- 05:51
- $1,000
- 06:02
- participation in phase I trials participation is affected
- 06:04
- participation in phase II and III trials is NOT as affected
- 06:17
- Vulnerable populations
- 06:28
- children pregnant women critically ill individuals elderly people prisoners disabled individuals ethnic minorities economically and educationally disadvantaged people
- 06:46
- Predisposed to exploitation & undue inducement!
- 06:54
- Research
- 06:55
- Sponsored by: developed countries
- 06:56
- Carried out in: developing countries
- 07:05
- Financial benefits
- 07:18
- U.S.A.: $300-350 million
- 07:23
- India: $25 million
- 07:26
- Vulnerable populations
- 07:31
- Zika fever
- 07:31
- Malaria
- 07:32
- AIDS
- 07:32
- Tuberculosis
- 07:33
- Respiratory viral infectioms
- 07:36
- 1975-2004:
- 07:38
- 1,556
- 07:42
- 10 /
- 07:51
- almost 1/3 of all clinical trials were conducted in developing countries
- 08:05
- Global burden of disease
- 08:07
- 10/90 gap
- 08:09
- Less than 10% of all globalglobal health care expenditures is invested in research for diseases that account for 90% of the global burden of disease
- 08:16
- Diseases from developing countries are neglected
- 08:22
- Vulnerable populations
- 08:28
- informed consent subject payment
- 08:37
- minimised standard of care
- 08:47
- Mother-child transmission of HIV infection trials
- 08:51
- from late 1990s
- 08:59
- zidovudine -
- 08:60
- short dose
- 09:06
- longer course
- 09:18
- Solving the ethical issues
- 09:26
- international guidelines
- 09:38
- Informed consent
- 09:39
- Subject payment
- 09:40
- Vulnerable populations