RE: Pre|CISION+ and pre|CISION ADC6 Apr 2024 12:57
Kingsley
Why does Wikipedia say , what I have pasted below about pivotal trials? Are all phase2 chemo trials are pivotal then?
Also if dox has been in use for over 50 years and there are already some indication of efficacy in phase1 and delivery system of delivering dox to the tumour via cleaving of FAP is working as it has been designed then chance of success surely is higher that a regular trial for a regular chemotherapy?
A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects.[1] A successful pivotal trial is required as evidence for drug marketing approval by the relevant approval authorities, such as the European Medicines Agency, Health Canada or United States Food and Drug Administration (FDA).[1]