The distinction between clinical care and clinical research is important due to the ethical and legal implication

1. Clinical Care vs. Clinical Research
By:
Weam Banjar; BDS., MS. in clinical research., Comp.dent fellowship

2. Objectives
• What is the difference between research and standard of care?
• How do you define this difference in a study protocol
• How can you balance the roles and responsibilities between
standard of care and research

3. Standard of care
• Primary goal: To promote
the well-being of the
individual patient
• Treatment and assessment is
tailored to individuals
• Ethically, the potential
benefit of therapeutic care
prescribed to individuals must
outweigh the potential risk
Research
• Primary goal: to produce
scientific knowledge that will
improve clinical care for future
patients and for society
• An individual patient receives
treatment based on the
scientific design of research
protocol and not on
individualized care

4. • Research is done to assess if a treatment or a protocol is
efficacious and feasible for a larger population with certain
disease/ condition
• Research helps answer a question for the future health
• Standard of care focuses on individual needs in the present

5. • Line is sometimes is unclear, but it is an important distinction
• Important not to confuse research with standard of care
• Departure from standard of care is not necessary a research

6. What makes RESEARCH different from
STANDARD OF CARE
• Involve human subjects
• Test= intervention= to improve the standard of care
• Measures effect over the time
• Control group
• Must have method to measure intervention
• Focuses on unknown
• Must be done BEFORE a treatment/ protocol becomes a standard of
care
• Decision flexibility- Standard of care is based on clinical judgement,
research must stick to a pre-designed protocol

7. Clinical Care- DoctorClinical RESEARCH- Investigator
Answer questions
Test hypothesis to benefit the
general population
Acting for the best interest of the
individual patient medical
Risk for conflict of interest?!!

8. Issues to be considered in clinical
research vs. clinical care:
• Nuremberg code (1947)
• Declaration of Helsinki (1964)
• The Belmont report (1979)
• The status of clinical equipoise
Ethical dilemma of research involving human subjects

9. Importance of National Commission
(Belmont Report 1979):
• Laid groundwork for entire apparatus of institutional review of
research
• Logic of review by an outside body is predicated on the
distinction between research and therapy (as opposed to
trusting the “personal physician’s” good intentions and
professionalism)

10. Implications of informed consent:
• Informed consent a major ethical requirement for research
• Informed consent should start with a clear orientation to what
sort of setting one is in
• The patient-subject who thinks he is getting individualized
therapy when in fact he is being treated according to a research
protocol cannot give informed consent
• Blurring the distinction between research and therapy (e.g.,
similarity position) risks undermining the entire process of
informed consent

11. Therapeutic misconception
• Research subject’s belief that enrolling in research trial will (with
certainty) provide direct therapeutic benefit, despite what
appears to be an adequate informed consent process
• 40-80% of subjects showed basic misunderstandings of
research trial design
Appelbaum et al., Hast Cen Rep 17(2):20, 1987

12. Where does the misconception
originates?
• Assumption: subject’s psychological need for an effective cure
for her disease, despite honest effort at informed consent
• If investigator confuses clinical research with clinical therapy,
stage is set for subject to get erroneous impression as to basic
nature of the setting and activity

13. The status of clinical equipoise
• Similarity Position yields “RCT dilemma”
• How can randomization be justified within a therapeutic ethic?
• CE is an attempt to answer the RCT dilemma
• RCT is ethical only if the medical community is genuinely uncertain which of two
treatment arms is superior
• CE claims the virtue of preserving the basic duty of therapeutic beneficence
• No subject randomized to a treatment known to be inferior
• Therefore, CE exemplifies and logically implies the Similarity Position
• The Difference Position deals with the “RCT dilemma” by rejecting it as false

14. The status of clinical equipoise
• “The Declaration of Geneva …binds the physician with the words,
‘The health of my patient will be my first consideration.’”
• “The primary purpose of medical research…is to improve
prophylactic, diagnostic and therapeutic procedures and the
understanding of the aetiology and pathogenesis of disease.”
Declaration of Helsinki, WMA, 2000
• CE promotes the therapeutic misconception at all levels (subject,
investigator, IRB)
• CE promotes the larger misconception that both physicians and
research studies are nothing but retail pharmacies
• Focuses solely on what treatment is received, not how the setting is designed
or how treatment decisions are made