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Open-Label Extension Studies and Misinformation—Reply
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In reply
We thank Dr Schneider for his comments on our report.1 We share his enthusiasm for "well-conducted and methodologically sound randomized controlled trials."2 However, we do not agree that "as physicians, we should be comfortable prescribing medication for longer periods of time than the length of the randomized trials" based on the evidence from the shorter-term randomized trials and "patients' preferences." We believe that this prescribing comfort should be informed, to the extent possible, by the best available evidence.
Open-label extension studies are frequently incorporated in the design of randomized controlled trials for various excellent reasons. These include practical concerns such as initial trial recruitment and ethical considerations. The ethical factors include the potential value of providing a putatively efficacious treatment to participants who did not initially receive the benefit of treatment. Additionally, when a study includes an extension phase, there is a clear need to make all data . . . [Full Text of this Article] AUTHOR INFORMATION
Barry Reisberg, MD;
Rachelle Doody, MD, PhD;
Frederick Schmitt, PhD;
Steven Ferris, PhD
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