| I'm a bit puzzled why one would hold a press conference for a trial that hasn't happened yet - especially as this seems to be a phase 1 trial to test safety in humans. The development of medical interventions typically goes through a number of stages. The earliest stage is called the pre-clinical phase, where a candidate intervention is tested outside of humans, either in vitro or in animals. The images of the mouse and ferret teeth suggest this has been done. Phase 1 is when the intervention is first tested in humans, typically in small groups of usually dozens of participants. The aim here is not to evaluate efficacy - phase 1 studies are often too small for that - but to assess tolerability and safety, and to find the optimal dosing with respect to side effects. If an intervention appears safe in certain doses, it can then be evaluated for initial efficacy and continued safety in a phase 2 trial, which is larger (usually hundreds of participants). Think of it as a kind of pilot trial to see if the intervention has the desired beneficial effects without serious negative side effects, and to identify the dose with the best benefit/risk ratio. About half of the studies get past this stage. Those that do can enter phase 3, which is the full efficacy and safety assessment of the intervention. Again, about half of the phase 3 trials eventually make it to market. Of course, the intervention first needs to go to the health authorities for regulatory approval before it can be offered on the market. For an interesting study on costs during these phases, see e.g. https://pubmed.ncbi.nlm.nih.gov/32125404/ I'm obviously very excited about medical progress but if we had a press conference for every planned phase 1 trial we wouldn't be doing much else ;-) |
This is something Japan loves to do. We joked during covid that they kept making announcements that they were planning to have a meetings to prepare announcements.