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Replies to post #767607 on NorthWest Biotherapeutics Inc (NWBO)
05/13/25 6:13 PM
The JAMA paper says otherwise. The crossover was allowed based on it being a carrot for enrollment. Are you saying the 72 authors lied in that paper or what?
A crossover was considered necessary when our study began in 2007 to make patient enrollment and retention feasible when novel immunotherapies were not yet generally viewed as promising for cance
The crossover was also important to justify the placebo group for patients undergoing a leukapheresis—an invasive procedure necessary for blinding and for manufacturing vaccine but offering no benefit to patients in the placebo group if they could not receive their autologous vaccine.
The crossover design necessitated the use of external controls to evaluate OS. Traditional (ie, within-study) randomized control comparisons were infeasible, since most placebo group patients received DCVax-L through the crossover. When randomized clinical trials (RCTs) are not feasible, use of external controls is increasingly recognized as an effective way to enable comparative analyses of outcomes.8 There is also growing support for streamlining trials in the neuro-oncology field
