Stock DZ
08.07.2018 kl 15:09
829

Hi

Another thing the ABC study above tells us is the patients enrollment rate. The study recruited 124 patients in the course of 18 months with a patients median age of 65.1 years (between 05 April 2011 and 28 Sept 2012). with a total number of 15 clinical sites in the UK (only UK sites)

this gives an average of approx. 7 patients per month.

Now let refer to what Arctic analysis thinks about the recruitment rate:

" There is large variety in inclusion numbers for a (pivotal) trial within CCA, depending on i.e.
statistical powering related to the expected outcome. According to listed trials on clinicaltrials.gov,
the numbers range from some 40 to up to 400. We believe PCIB will be able to differentiate itself with regards to efficacy data and we therefore estimate 100-150 patients to be included in the two arm pivotal study, through engagement of some 30-50 sites. Due to the number of sites, the unmet need in CCA and the more accessible design of pivotal trials in general, we expect recruitment could be done rather quickly, some 9 to 15 months. We assume the time of follow-up to be similar to the
phase I expansion trial, in which patients, if eligible, are treated with Amphinex twice (second treatment some 4-5 months after the first). This would mean a minimum follow-up of 6 months per patient (after first treatment), with read-outs as late as at 18 months after study start"

Now if we consider worst and best case scenarios:

Worst case scenario:
*30 sites and 150 patients. now with double the # of site from the ABC-3 study we can assume an enrollment rate of 14 patients a month. Therefore the whole recruitment for the study can take approx 11 months

Best case sceranio:
*50 sites and 100 patients. now the # of site is 3.33 x. we can then assume an enrollment rate of approx 23 patients a months. resulting in only 6,5 months to complete the patient registration phase.

I believe Arctic analysis is conservative when it says the recruitment can take between 9-15 Months because based on the facts above from the ABC 3 study we can assume that this range is 6,5-11 months. so I think the enrollment phase can be finished super super fast. Here we have excluded any potential sites in geographical areas with high incidence rate such us Japan for example which will obviously speed up the process.




Redigert 08.07.2018 kl 15:10 Arkivert