Behind closed doors: the data monitoring board in randomized clinical trials.

The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

OBJECTIVES Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduc...

Response: Behind the closed doors of mentalizing. A commentary on “Another step closer to measuring the ghosts in the nursery: preliminary validation of the Trauma Reflective Functioning Scale”

Citation: Ensink K, Fonagy P, Berthelot N, Normandin L and Bernazzani O (2015) Response: Behind the closed doors of mentalizing. A commentary on “Another step closer to measuring the ghosts in the nursery: preliminary validation of the Trauma Reflective Functioning Scale.” Front. Psychol. 6:697. doi: 10.3389/fpsyg.2015.00697 Response: Behind the closed doors of mentalizing. A commentary on “Ano...

Independent data and safety monitoring in psychiatric intervention research.

A data and safety monitoring board (DSMB) is a multidisciplinary group of scientists that monitors a randomized clinical trial. Although DSMBs have been used for clinical trials in cardiology, oncology, and infectious disease for decades, it was not until the late 1990s that the National Institute of Mental Health (NIMH) initially required a DSMB for some of its larger trials. The NIMH mandate ...

درماتولوژی مبتنی بر شواهد: گزارش درست مقایسه‌ی پیامدها در کارآزمایی‌های بالینی

According to evidence-based medicine, randomized controlled clinical trials are a group of research designs which provides the highest level of clinical evidence, particularly regarding therapeutic or preventive interventions. Considering the dramatic increase in the number of published clinical trials in medical journals, the readership need to have knowledge about the problems that may occur ...

Behind Closed Doors: Revisiting Air Command’s ‘Lack of Moral Fiber and Waverer Disposal Policy’ and its ‘Treatment’ of Neurotic Cases, 1941-1945