Time frame for enrollment of B-OM due to inclusion criteria....I don't know much about oncology clinical trials specifically, but I know a little about trial design in general. I am assuming the investigators are aiming to find patients who are most likely to develop moderate-to-severe OM following their radiation and chemo treatments. To do so, they set the inclusion criteria very carefully, and often times very selectively. Unfortunately this can lead to longer recruitment times.
This is important in a placebo-controlled trial to tease out whether the drug had its intended affect. So, the inclusion criteria are set very stringently to make sure patients are highly likely to develop significant OM. If the inclusion criteria were set more relaxed, there may be a higher likelihood that patients with less severe OM are included (or worse, those who have some spontaneous remission of their OM symptoms during the treatment period). Thus, it becomes a nightmare to calculate a statistically significant delta (i.e. change) for OM score, and whether it is due to the drug or not.
Also, the investigators cannot wait until OM has developed in this trial, because B needs to be administered prior to, or very early in the radiation/chemo protocol (the MOA for B-OM is really more of a preventative effect, though it will likely also provide curative benefit too). So, we have to go after a specific tumor type, in a specific location, with a specific chemo/rad treatment protocol, all with the knowledge that these lead to a high probability of moderate-to-severe OM.
The question then becomes, how long does it take to identify such highly specific patients, not to mention recruiting them into a new investigational drug trial for something ancillary to their cancer treatment? In a best case scenario, here is my projection, If we assume the following:
1. the first 3 sites were announced in late May/early June (per press release)
2. the sites came online every 2 weeks (takes time for the CRO to do site initiation visits)
3. the next 2 sites start recruiting in mid/late Aug
4. each site can recruit 1 patient per week into the B-OM protocol (may be wishful thinking...particularly in places like South Dakota)
We may be close to the half way point in recruitment (n=34 by my calculation), and it may take another 6-8 weeks to complete recruiting. The last patient will require the 7 week treatment + 28 day follow-up. This takes us into mid/late Dec. Allow another 1-2 months for patient drop-out/hiccups, etc, and now we are looking at mid-Q1 '16 before we complete the protocol. Then allow 1-2 months for data lock, site close-out visits, and then top-line data analysis (recall this is a CRO doing all of this...CTIX does not have a clinical dev team cracking on this). If recruitment is slower (e.g. 1 patient every 2-3 weeks) then this drags out to the predicted completion data of June-'16. Again, only a projection IMO.
BTW, first time poster and I'm long (i.e. married to) CTIX
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