NorthWest Biotherapeutics Inc (NWBO)

[User-840664]

"a dedicated well-designed 2nd trial would have been the real answer instead of a round of intrinsically flawed data constructions. Post hoc analyses are hypothesis generating and nothing else.

To conclude, stringently designed and executed prospective randomized clinical trials remain the gold standard for evaluation of efficacy of novel treatments. Control of known, but also unknown, confounders are crucial in clinical trials, and the present analyses of the DCVax-L trial offer neither. Further methodological research and definition of standards that ensure adequate scientific rigor is needed to define the possible role of externally controlled clinical trial data for retrospective analyses or within prospective clinical trials. This concerns both healthcare and regulatory decision making in (neuro-)oncology.

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10076936/