The Nature of the P Value
Stuart J Pocock, Gregg W. Stone · New England Journal of Medicine · 2016
identify potential new collaborators. 2 Nevertheless, under the terms of approval of our retrospective study by the institutional review board, we are not permitted to release patient-level data.Our retrospective study includes not only patients in different clinical trials but also patients who received "standard of care" treatment that was not determined by a specific clinical protocol.Different consents apply to the different populations included in the analysis; therefore, in order to perform our retrospective study, we applied for and received specific approval from the institutional review board under internal protocol 2281 of the Fred Hutchinson Cancer Research Center.Furthermore, Hourigan and colleagues request disclosure of patient-level data pertaining to a large number of individual patient-related factors, some of which were not collected at the time of the chart review or included in the analysis.Although we agree that some of these factors might be worth examining, to collect, analyze, and release such information would require time and another institutional review board application.In response to the other questions by Hourigan et al., bone marrow biopsies with cytogenetic analysis were performed before transplantation in all the patients with myelodysplasia.In our system, we do not have a way of determining how many patients are considered for transplantation but do not undergo transplantation.The study by Walter et al. included transplants from both related and unrelated donors, and a total of 152 patients in that study were also involved in our study.With the goal of sharing data among various institutions in the future, we are willing to submit a new institutional review board application and collaborate with Hourigan and colleagues or others.