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Good%20Research,%20Bad%20Choices?

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Must be 'clinical equipoise' What might be differences between standard and new treatment? ... Two treatments are in equipoise: incommensurable (known) differences ... – PowerPoint PPT presentation

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Title: Good%20Research,%20Bad%20Choices?


1
Good Research, Bad Choices?
  • Mary Coombs

2
What Makes Something Research Rather Than
Treatment?
3
What Makes Something Research Rather Than
Treatment?
  • Primary Goal is to Answer a Research Question

4
What Makes Something Research Rather Than
Treatment?
  • Subject welfare isnt primary goal
  • risks to subjects must be reasonable in relation
    to anticipated benefits, if any, to subjects and
    the importance of the knowledge that may
    reasonably be expected to result

5
What Makes Something Research Rather Than
Treatment?
  • Decisions are based on protocol in first instance
  • Not on contextual best interests of this person

6
What Makes Something Research Rather Than
Treatment?
  • Usually requires testing and procedures beyond
    those needed for treatment

7
What Makes Something Research Rather Than
Treatment?
  • Usually/ ideally is RCT
  • Neither subject nor researcher know if is getting
    treatment A or treatment B

8
Proposed The main purpose of a clinical trial
is to benefit future patients rather than the
patients in the trial
  • Do you think this is true?

9
Proposed The main purpose of a clinical trial
is to benefit future patients rather than the
patients in the trial
  • What did doctors at a (Boston-based) academic
    institution think?

10
Proposed The main purpose of a clinical trial
is to benefit future patients rather than the
patients in the trial
  • What did doctors at a (Boston-based) academic
    institution think?
  • Yes 45.9
  • Unsure 29.5
  • No 24.6

11
This misunderstanding is common enough to have a
name
  • Therapeutic Misconception

12
Law and Ethics of Treatment
  • (a very summary summary!!)

13
Law and Ethics of Treatment
  • Option A Standard Treatment
  • Informed Consent needed

14
Law and Ethics of Treatment
  • Option B
  • Reasonable Experimental Treatment
  • More Detailed Informed Consent needed

15
Law and Ethics of Treatment
  • Option C
  • Unreasonable Experimental Treatment
  • Not permitted
  • Consent Irrelevant

16
Law and Ethics of Treatment
  • There is Potential Tort Liability if
  • 1) there is a bad outcome and
  • 2) there was
  • a. Unreasonable Experimental Treatment or
  • b. Insufficient Informed Consent or
  • c. Execution of Treatment fell below standard
    of care

17
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18
How Can Research Study be a Bad Choice? Phase
One Trial
  • Consider
  • Risk to subject
  • Benefit to subject
  • Benefit to knowledge/future patients

19
How Can it be a Bad Choice? Phase One Trial
  • Risk to subject
  • Significant more toxic dose than previously
    given to humans

20
How Can it be a Bad Choice? Phase One Trial
  • Benefit to subject?
  • Minor in fact
  • Protocol not designed to test efficacy

21
How Can it be a Bad Choice? Phase One Trial
  • Benefit to knowledge/future patients?
  • Subjects say are doing to find a cure for
    themselves
  • Are either altruistic or misunderstand the free
    rider option

22
Downsides of being a Subject Other Clinical
Trials
  • Apart from Randomization
  • Rigidity of protocol
  • Risks/Inconveniences of Additional Testing
  • Not told of interim results

23
Upsides of being a Subject Other Clinical Trials
  • Apart from Randomization
  • Access to better quality care than P might
    otherwise obtain
  • Academic medical center trials
  • Effect of limits on health insurance

24
Upsides of being a Subject Other Clinical Trials
  • Apart from Randomization
  • Possible Access to Drug/Treatment not otherwise
    available
  • If new drug
  • If (some) doctors wont provide off-label
  • If new technique not available outside trial
    setting

25
Upsides/Downsides of being a SubjectRandomizatio
n
  • Must be clinical equipoise
  • What might be differences between standard and
    new treatment?

26
Possible Differences to be tested by study
  • Effectiveness
  • Expected Mild-to-Moderate Side Effects
  • Level of Risk of Serious Side Effects
  • Convenience
  • Cost

27
Possible Outcomes after study
  • New treatment is clearly as good or better on all
    dimensions
  • Standard treatment is clearly as good or better
    on all dimensions
  • Two treatments are in equipoise incommensurable
    (known) differences

28
Clinician decisions after study
  • New treatment is clearly as good or better on all
    dimensions USE NEW
  • Standard treatment is clearly as good or better
    on all dimensions USE STANDARD

29
Clinician decisions after study
  • Two treatments are in equipoise incommensurable
    (known) differences
  • Choose what is best given specifics of this
    patient
  • Engage patient to help choose given subjective
    preferences
  • E.g. risk vs. efficacy
  • E.g. cost vs mild/moderate likely side effects

30
Clinician decisions before study(if new
treatment available outside study
  • Two treatments are in equipoise incommensurable
    (unknown) differences
  • Choose what is best given specifics of this
    patient
  • Engage patient in choice given subjective
    preferences
  • E.g. risk vs. efficacy
  • E.g. cost vs mild/moderate likely side effects

31
Is informed consent the answer to the bad
choices/good study dilemma?
  • Are people free to be altruistic?
  • Are people free to make bad choices?
  • Should we be skeptical that bad choices are
    freely made and fully informed?

32
Does Informed Consent Form Matter?
  • written documentation matters
  • Research form is more important than treatment
    form
  • Research form is easier to prepare than treatment
    form
  • Liability I always tell people I must have
    told Ms. X

33
What might a subject want to know?
  • That is a research study
  • Potential future benefits of research study
  • Intervention being studied
  • Alternative standard care? placebo?
  • Are there third alternatives available?
  • Risks of Standard Care
  • Risks of Proposed New Treatment

34
What might a subject want to know?
  • Benefits of Standard Care
  • Benefits of New Treatment
  • Risks/discomforts inherent in participation
  • Obligations of being a subject
  • What happens if leave study prematurely

35
What might a subject want to know?
  • What recompense () for participating?
  • What consequence if things go wrong? Who pays for
    what?
  • Facts about person offering to enroll me might be
    relevant to determining his/her motivations

36
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37
Are these all in the standard forms?
  • Research study/ purposes/benefits yes
  • Treatment being tested and randomized
    alternative yes
  • Availability of third alternatives?
  • Sometimes
  • Often doesnt include option of study treatment
    outside research study

38
Are these all in the standard forms?
  • Risks/discomforts inherent in study
  • Generally included
  • Tests may be referred to as routine
  • This may be understood as risk-free rather than
    common outside the research protocol

39
Are these all in the standard forms?
  • Obligations/effect of leaving prematurely?
  • Usually covered
  • Doesnt indicate that wont be told of interim
    results

40
Why might a subject want to know and a
researcher not want to reveal this??
  • Results show new treatment more efficacious
  • Confidence interval overlaps null hypothesis
  • Compare researcher interest and patient interest

41
Are these all in the standard forms?
  • Risk/benefit of standard and alternative?
  • Yes, but boiler-plate
  • COST study of laparoscopic surgery for colon
    cancer
  • Form language it is possible that the new
    technique may change the way the tumor grows back
    after surgery if it does
  • Vs. Benefits of smaller incisions and faster
    recovery

42
Are these all in the standard forms?
  • Financial Issues
  • Payment to P for time/inconvenience?
  • Y
  • Coverage of Medical Costs during trial? Y
  • Compensation for damages from trial?
  • Usually not included/not covered
  • Incentives to Researcher/Doctor to Include P in
    trial?
  • No

43
Can we do needed research if we tell the truth
and the whole truth? Can we treat subjects with
something like the ethics we use for patients?
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