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RE: [IP] Good Planning and Statistics - Jim H.

email @ redacted wrote:

> Specifically, related to the DCCT I have heard that 99% of the subjects
> completed the study.   I also understand the 1% included one or more
> deaths.....   Any idea how the DCCT compares in subject completion with
> other studies of similar duration and number of participants.

It's really not useful to compare studies in this manner.  Each study has
its own set of assumptions.  Excellent participation and low loss to follow
up (known as censored data) doesn't mean much in the way of validity of the
outcomes and conclusions.

> Since the DCCT results were so conclusive (study stopped early), might
> there have been an ethical situation of continuing the study with a
> "conventional treatment group"?

Almost certainly.  The results of the DCCT were so dramatic that tight
control immediately became standard of care.  Giving less than standard of
care in a research protocol is unethical.

I think I have to interject here that a critical part is in research
protocols.  Many patients still do not exercise tight control.  This may be
a matter of physician training, or it may be poor compliance by the patient.
But this is clinical care, not research.  It would be improper for any IRB*
to approve a protocol that provided for less than standard of care.

Jim Handsfield
Member of IRB "A"
Centers for Disease Control and Prevention
email @ redacted

*IRB = Institutional Review Board
IRB's are mandated under Chapter 45 of the Code of Federal Regulations,
Section 46 (45 CFR 46).
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