How should the DSMB deal with the situation if the data do not support the stopped trial? What should the patients be told concerning the results of the two trials when one trial continues and the other is stopped? This DSMB case study reports on such a situation for two randomized ...
A data and safety monitoring board (DSMB) reviewed safety data throughout the trial. The trial was registered with ClinicalTrials.gov, number NCT01847872, where the trial protocol is available. Role of the funding source The trial was sponsored by the Medical Research Council and funded by the...