Cheaper, faster, development of more effective new treatments
*Corresponding author: Huib M Vriesendorp, MD, PhD, POBox 2855, Silverthorne, CO, USA and Phase2Therapy, the Hague, the Netherlands, www.Phase2Therapy.com, 1.970 262 1522
Hal A Droogleever Fortuyn, MD, PhD, Arnhem, the Netherlands, Dimor Elbers, PhD, Lonza Benelux, Breda, the Netherlands, Nabil Kahter, MSc, Saint Louis University, St Louis, MO, USA.
A historical review of the ‘strategic’ development or accidental discovery of new therapeutic interventions demonstrates that ‘evidence’ is needed to confirm progress. As early as 1940 Carl Popper provided a prescription for the ‘Logic of Discovery’. A study will only provide new scientific information if it has a ‘falsifiable’ null-hypothesis.
If the null-hypothesis is proven to be ‘false’, another falsifiable hypothesis needs to be formulated and tested. The first time a null hypothesis is confirmed is not enough to accept the null-hypothesis. Each positive confirmation of the null hypothesis increases the chance the investigators move in the right direction.
The use of double blind randomized trials as recommended by FDA and EMA have no falsifiable null hypothesis. If the study collects enough patients one arm will always be better than the other arm at a probability of <0.05, but a repeat study -almost never done- could show the other arm of the study is the best one with same low p-value.
Radiolabeled Immunoglobulin Therapy (RIT) in patients with poor prognosis solid tumors, allows for the introduction of a falsifiable ‘null-hypothesis’ and the determination of radiation dose effect curves for normal tissues surrounding the tumor as well as tumor dose effect curves, without exposing the patient to unpredictable risks and increasing the chance for a beneficial tumor response.