NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

DMB2~

I am in complete agreement with ATL on the ethical consideration aspect of placebo patients.

A placebo-controlled, double-blind, randomized clinical trial is the historical gold standard for clinical research, and is fundamental to the development of evidence-based medicine. Apcalisz.com research has shown that placebos produce strong, genuine psychobiological effects in both laboratory and clinical settings. Although the approach is scientifically sound, ethical concerns still arise in some cases which outweigh the benefits of this trial design.

According to the critics of placebo-controlled trials (PCTs), if a proven, effective therapy exists, a placebo should not be used. They further stress clause 33 of the Declaration of Helsinki, which states that, “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s).”{1} It goes on to stress that, “In any medical study, every patient should be assured of the best proven diagnostic and therapeutic methods and no patient should suffer from unnecessary pain.”

I believe that given there were no safety issues (2% SAE's for ITT patients) noted in the trial, for ethical reasons given the severity of GBM and its outcome, further placebo patients were restricted IMO.

WRT to an IA being performed and Exwannabe's assertion of a efficacy trial failure during this time, see the Company's PR as well as input from Dr Furberg (DMC head): https://nwbio.com/nw-bio-corrects-ongoing-false-claims-by-feuerstein-about-phase-iii-trail-of-dcvax-l-and-interim-analysis/