The good "research" was that FDA halted the trial, and the trial was a failure. A new trial should have been done in 2018, but the problem was that LP knew that even another trial would fail. Her major mistake was taking on GBM first, the hardest cancer to treat because of it's aggressive nature and the blood brain barrier... (which remains an obstacle for all brain diseases) I am anxious to see how this all plays out. I think it's obvious that an approval with NICE reimbursement is not coming and Advent is not what it once was.
Why has it been 2 years with no decision? Maybe this? 👇️
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.