@Chrkni
Good point and I was expecting this dilemma to be brought up to the discussion. Now here is my reasoning.
First of all what I presented earlier is a PDD process, or rather say an improved solution which implies patient centricity and cost effectiveness for the sponsor. If you go to pdd website there is a whole webinar on this.
In case of pci biotech, a small company with limited Human Resources it will become even more difficult to act on timely manner for site activation. For example to activate the site one has to travel to provide training (our product is not as friendly as swollowing a pill
). Therefore it will be pretty difficult to prioritize which site should have more focus thus activated on time. Take the example of Spain, sites activation in Madrid happened at different times where one would think wait for all sites in the same city to be ready paperwork wise and then take a one trip to do the training for all the sites to activate them. That did not seem to be the case.
Now coming to first patient enrolled. Usually biotech companies report first patient dosed FPD, since this is a randomized study the company used “enrolled” as FPD may give the impression that the patient has undergone fimachem treatment not placed in control arm.
If you read in pdd, the company used the term enrolled and also used the term identified. Therfore I am under the impression that patients were identified / enrolled first by the sites before site activation and what the company means by first patient enrolled is actually first patient who completed first part of the treatment (after all prior tests and screening). And to complete the first part in the case of Fimachem it is actually +4 days
My point is and I could be wrong of course is that there should not be anything preventing pdd to apply this new lean process to the Release study, on the contrary I can only see benefits for both the patient and the study sponsor, this will prevent the company to spend resources on “dormant” sites which also should be a learning from both phase 1 and extension study.
I’m saying this assuming that this pdd process is now a common practice inside pdd and not a special service with extra cost