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I thought you were talking about inclusion/exclusion - that is before randomization. Once a patient is randomized, every effort should be made to avoid loss to follow-up or exclusion. V > ---------- > From: Jeanne Lenzer[SMTP:[log in to unmask]] > Reply To: [log in to unmask] > Sent: Friday, August 17, 2001 2:59 PM > To: [log in to unmask] > Subject: FW: uncertainty principle > > -----Original Message----- > From: Jeanne Lenzer [mailto:[log in to unmask]] > Sent: Friday, August 17, 2001 3:44 PM > To: [log in to unmask] > Subject: RE: uncertainty principle > > Hi Victor - > > Thank you very much for your explanation. It seems to me (and forgive me, > I'm merely a journalist here trying to learn) - but it seems to me that > what > you say is true - but that it may not be relevant to the study protocol > that > included that paragraph. > > The uncertainty principle, it seems to me, is what should be operative in > order to determine whether a study should be undertaken at all. Do we > know > if drug A is definitely better than placebo? If we don't know the answer > to > that, then and only then, is a study ethical. However, once we determine > that we are uncertain and a study is ethical - to allow clinicians to > remove > patients from randomization still seems to be risky to me and I wonder > about > that undermining the study's genuine randomness. > > For example, what if a clinician has a bias that the drug must work better > than placebo and therefore chooses to pull out a number of the "sicker" > patients but not the less sick patients because he or she thinks "it's > really important that my patient get the active drug"? Could that change > the spectrum of patients receiving treatment vs. non-treatment? Also, > what > if the researcher has vested interests (is receiving drug company funding) > - > could she or he then (consciously or unconsciously) pull patients out of > the > randomization process in a manner that influences the process? I guess a > lot of this depends on when the patient is pulled - before or after > randomization? But even then, prior exclusion of all "really sick" > patients > could affect the process? Or am I hopelessly lost? > > Thanks much > jeanne > > -----Original Message----- > From: [log in to unmask] [mailto:[log in to unmask]] > Sent: Friday, August 17, 2001 2:55 PM > To: [log in to unmask] > Subject: RE: uncertainty principle > > > This is not liberal, it is ethical. If there is no doubt that active > treatment is in the best interest of the patient then not offering it to > her > would be substandard care (same for clearly contraindicated medication). > Only those patient-physician duets that are certain that they do not know > whether treatment A is better than treatment B are in a reasonable > situation > to join the study. > There is no way around this. The dangers of not following this principle > is > patient desertion, off-study use of study medication, and other forms of > noise that will limit the ability of the study to show a treatment effect > resulting in a monumental waste of time and resources for all involved. > Does this answer your question? > V > > > ---------- > > From: Jeanne Lenzer[SMTP:[log in to unmask]] > > Reply To: [log in to unmask] > > Sent: Friday, August 17, 2001 1:32 PM > > To: [log in to unmask] > > Subject: uncertainty principle > > > > 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 > > Cell phone pager: 914-399-5001 > > [log in to unmask] > > > > > > >