Prof Sir Jonathan Van Tam - promoting new thread (Oakleaf credit)20 Jan 2022 16:38
Dear Oakleaf - thanks for raising my awareness of this online webinar - I'm now registered - yes very very interesting timing I agree with you. Here is my submitted question below and the same thrust of many messages I sent to UK Government & Kate Bingham Leader of the UK Vaccines Taskforce when Covid all kicked off:
Question submitted to JVT:
Regarding the COVID pandemic, with the benefit of hindsight, does the speaker agree that there is a highly important role for large cohort “Real World Evidence (RWE) studies”, that are rapidly expedited, and volunteer driven, within regulatory ‘lite’ clinical frameworks, to inform evidence of broad efficacy and safety benefits for drug assets in post-phase II (such as Soton Biotech, Synairgen’s SNG001 that exhibited a very clean safety profile and has existing clinical uses in other delivery forms)? This would remove the blockage of elongated and overly onerous regulated clinical trials processes for standard pharma assets, assuming presence of keen volunteers that legally agree to any treatment risk. If not, where would he draw the line of % death rate threshold of any new emerging infection variants, before he would recommend RWE methods as the way forwards to more rapidly introduce effective medicines and perhaps save countless lives globally?