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L7 Therapeutic trials 2 :rabbit: (Follow up :leaves: (Losses to F/U must…
L7
Therapeutic trials 2
:rabbit:
Follow up
:leaves:
= Conducted a
Predetermined intervals
needed to detect the Occurence of trial endpoints
(การวัดค่า ณ เวลาๆหนึ่ง)
Freq & Duration to F/U will depends on:
Type of endpoint
eg. Response to Rx, Deve. Of new ds, Progression of ds, behavior change, Sustainability of change
The level of risk
(The higher the risk, the more frequent the F/U)
Losses to F/U
must be minimized because
Losses are often
selective & introduce bias
(Eg. High risk persons drop out of trial)
Losses to F/U Should be comparable in the Intervention & control arms to avoid biased companions
Losses to F/U will :arrow_down: person-time of Observation -> :arrow_down:study power
If คนหายไป
> 20%
of estimated sample size ->
that research is DOOM (USELESS AF)
Blinding
Do to Minimize participant or observe bias
Analyses
Intent-to-treat
:star::star:
เวลา discuss will speak of this
Analyze
ALL persons randomized
(even if some don’t receive intervention or drop out b4 completion of Rx)
Least bias & Most conservative
As treated
(“Per protocol”)
Analyze
only those who actually complete the Rx
Potentially biased by Selection of the most complaint & often lowest risk population
Statistical methods
:no_entry:
Stopping rules
Trials should hv
predefined stopping rules
to avoid
Prevention undue risk to participants
(eg, Rx causes Adverse effects)
Depriving the control group of an effective intervention
(eg. FDA announce that Rx is effective)
Continuing an ineffective intervention (futility or conditional power analysis)
eg. ยาไม่ได้ผล จน FDA บอกให้หยุดเถอะ
Trial Monitoring
Ethical principles (Belmont report)
Autonomy & respect for persons
Beneficence
(maximize benefits, minimize harm)
Justice
(Equal chance to enjoy benefits)
Yay
Trial registration
(end เถอะ)