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Could anyone explain the pros and cons of the following:
Uncertainty
principle (absence of proof): Further
inclusion and exclusion criteria are not specified precisely but are guided by
the uncertainty principle (or absence of proof for that particular patient).
If, for whatever reason, the clinician is convinced that a patient fulfilling
the above criteria should be treated, that patient should be given open label drug
and not randomized. If the clinician is convinced that a patient should not be
treated (for whatever reason), the patient should not be included in the trial.
Only those patients who fulfill the eligibility criteria AND for whom the
clinician is still substantially uncertain about the balance of risks and
benefits of active drug should be randomized.
Can this kind of enrollment liberalism cause
a failure of true randomization?
Does it introduce spectrum and other biases?
Thank you any and all for any insight you
can give this underfed journalist.
Jeanne Lenzer
Freelance writer
191 Otens Rd.
Ellenville, NY 12428
USA
Office phone: 845-647-3670
Office fax: 845-647-3670
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