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See Benjamin Dublejovic's (?Spelling) excellent article on the uncertainty principle and pharmaceutical company-sponsored research Lancet 2000 ( I believe). He also contributes to this list and I am sure would offer you more background if you need it. Dan Sontheimer -----Original Message----- From: Jeanne Lenzer [mailto:[log in to unmask]] Sent: Friday, August 17, 2001 2:33 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] DISCLAIMER: The information in this message is confidential and may be legally privileged. It is intended solely for the addressee. Access to this message by anyone else is unauthorized. If you are not the intended recipient, any disclosure, copying, or distribution of the message, or any action or omission taken by you in reliance on it, is prohibited and may be unlawful. Please immediately contact the sender if you have received this message in error. Thank you.