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Research ethics 2 - Lecture notes 9

pt 2
Course

Bio-Medical Ethics (PHI 325)

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Academic year: 2018/2019
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North Carolina State University

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Research ethics (2) How we do medical research now: the science of clinical trials. Most medical research involving human subjects takes form of CLINICAL TRIAL. 1. Clinical Trial: description Scientific study designed to test a medical intervention in humans (Vaughn, Aim is to determine effects, especially efficacy and safety. Effectiveness and side effects of treatment are tested administering it to a human subject. Clinical trials provide strongest and most reliable evidence of efficacy (better than animal trials or clinical observation). o They are carefully designed to eliminate bias, avoid errors. The Randomized clinical trials (RCTs) o In era of scientific medicine: RCT is standard technique for testing and changing diagnostic and therapeutic methods. o Procedures to rule out bias: test design: Neither investigators nor subjects know who is receiving drug being tested: (addresses One group of patients given drug being tested (experimental group), and the other (control group) placebos (nowadays, more often established drug that is the of To get useful information, researchers must study the relevant differences between the two groups that emerge AFTER intervention: o Without control, tell whether result is due to treatment or some other factor (including with control group, there is more reason to believe that relevant effects in experimental group due to treatment. o For treatment to be judged effective, subjects in treatment group must show significantly greater improvement than those in placebo group trial) or those receiving standard treatment trial). Randomization: assigning subjects randomly to groups. o Control and experimental groups share relevant characteristics. (Minimizes bias resulting from assigning subjects to particular groups, i., selection bias.) o Minimizes possibility that unconscious bias leads to placing preferred subjects into a particular group. 2. Clinical Trials: structure and regulations Follow procedure (regulated US Food and Drug Administration (FDA)): Preclinical: animal experiments to determine toxicity. therapeutic index, potential hazards). Clinical: tested in humans. o Phases: Phase I: Nontherapeutic:Testing involves small number of healthy human volunteers. Aim is to evaluate safety, and determine NOT to determine its effectiveness. Phase II: Testing in larger group of people who might benefit from it, to get preliminary indication of effectiveness and further test safety. Phase Testing in much larger group in different places, to confirm effectiveness, monitor compare it with standard treatments, etc. Licensing. Phase IV: After established as standard treatment, data collected to refine its use. 3. Moral principles and human research: Agreement in bioethics on general moral principles that (with the help of derivative principles) should govern human research: autonomy, beneficence, justice (Belmont Report). At heart of disputes: beneficence: Obligation not to harm seems to conflict with aim of science. Clinical trials set up in such a way that patients in control group get less than best available treatment. Such patients being treated merely as a means to the end of scientific knowledge? Debate: o Physician violates obligation to act in best interests of patient (because of randomizing feature of clinical trials (see Hellman and Hellman). o Response: If efficacy of treatment is not known, there is no breach of because there are no good grounds for assigning patient to one or other group in the trial. While in doubt about the merits of the evidence does not support one over the other, physicians are in state of equipoise: rationally balanced between the alternatives. Conceptual question about what equipoise means: Is it merely a subjective mental state of physician or disagreement about treatment efficacy in the medical and scientific community? Conceptual question about what means: Those that advocate RCTs with no reservation employ argument that only RCTs provide adequate scientific foundation for medical beliefs and opinions. Hence physicians provide best available treatment until trial has been conducted and information with required statistical degree of assurance has been established. (And so they oppose the RCT on the grounds that it is incompatible Readings: RCT: ethical problems (Hellman and Hellman, Conflict for physician acting as scientist (Hellman and Hellman): o relationship implies right to best judgment and care. interests primary. o The methods used in RCT may involve violation of this duty because they require ignorance about therapy provided to patient on grounds of advancing science and medical treatment in the future. o Conditions for acceptability of randomization: Physician have opinion about the efficacy of the treatment. Physician has no preference for new vs. standard treatment (EQUIPOISE). If physicians form a view about the new treatment before the termination of the trial, grounds for legitimacy of randomization no longer available. Principle of equipoise requires committee (to stop trial if accumulating data destroy the state of equipoise). Just because trial provides greater certainty, this mean that views held with less certainty are without value. Physicians can acquire knowledge in other ways. It is highly debatable that only randomized clinical trials can provide valid information or that all information they produce is true. Argument involves false dichotomy: either you have evidence or else only got a a worthless prejudice. But experience with own patients, information from colleagues, nonrandomized test results amounts to more than even when the evidence conclusive or definitive.

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Research ethics 2 - Lecture notes 9

Course: Bio-Medical Ethics (PHI 325)

53 Documents
Students shared 53 documents in this course

University: North Carolina State University

Was this document helpful?
Research ethics (2)
How we do medical research now: the science of clinical trials.
Most medical research involving human subjects takes form of CLINICAL TRIAL.
1. Clinical Trial: description
Scientific study designed to test a medical intervention in humans (Vaughn, 194/222).
Aim is to determine treatment’s effects, especially efficacy and safety.
Effectiveness and side effects of treatment are tested by administering it to a human subject.
Clinical trials provide strongest and most reliable evidence of treatment’s efficacy (better
than animal trials or clinical observation).
oThey are carefully designed to eliminate bias, avoid errors.
The “gold standard”: Randomized clinical trials (RCTs)
oIn era of scientific medicine: RCT is standard technique for testing and changing
diagnostic and therapeutic methods.
oProcedures to rule out bias:
“Double-blind” test design:
Neither investigators nor subjects know who is receiving drug being
tested: “blinding” (addresses “treatment bias”).
One group of patients given drug being tested (experimental
group), and the other (control group) placebos (nowadays, more
often established drug that is the “standard of care”).
To get useful information, researchers must study the relevant
differences between the two groups that emerge AFTER
intervention:
oWithout control, can’t tell whether result is due to treatment
or some other factor (including “placebo effect”); with
control group, there is more reason to believe that relevant
effects in experimental group due to treatment.
oFor treatment to be judged effective, subjects in treatment
group must show significantly greater improvement than
those in placebo group (placebo-controlled trial) or those
receiving standard treatment (active-controlled trial).
Randomization: assigning subjects randomly to groups.
oControl and experimental groups share relevant
characteristics. (Minimizes bias resulting from assigning
subjects to particular groups, i.e., selection bias.)
oMinimizes possibility that unconscious bias leads to
placing preferred subjects into a particular group.

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