RE:RE:RE:RE:RE:RE:Spider Plot There are actually studies done on recruit in clinical trials you can find them online. I looked at this some years ago. Those finding suggest you have super-recruiters where the doc is super engaged with the program, in a sense becomes professionally invested and these few sites become the main recruitment sites. Then at the other end there are docs that sign on to the program but effectively don't participate. That seems to be the state of play in every trial, some centres just become the main recruiting sites, I think it's as much human nature and switched on docs as it is anything that THTX or the CRO can manage. I can't help thinking Shah is one of our super-recruiters.
This is a general industry finding. If the CRO is honest with THTX they should be understanding this and have prep'd for it. They are not doing some complex innovative trial here. This is a route well trodden by previous oncology trials. Many of these things should have been baked into their planning.
Wino115 wrote: Sums it up basically. To answer your question, I don't think THTX mgmt ever stated all were recruiting. It was just noticed by someone that the clinicaltrial.gov website updated the language for all 6 sites to recruiting. There was PR from both MIDWEST and the other TX site that also said they were looking. But I don't think anyone has actually stated LA was recruiting except for the language change on the website. Given the size of the population center, it certainly would behoove them to get moving in LA.
SPCEO1 wrote: I think we should be assuming the patient recruiting situation is behind schedule until the company states otherwise. First, has the company ever stated that all six sites are up and running efficiently? I don't recall that comment being made, but maybe I missed it. We earlier got a general "enrollment is going well comment" from Paul but we know now he is prone to overstate things (don't be too hard on him, I think it is in the job description of a biotech executive to be good at overstatement). Second, they are adding these other sites in the US, Europe and Canada now, five months into the trial? In July they indicated in a private call they might not pursue the European sites due to the extra hassle and cost involved. I had previously assumed early patient recruiting was going well enough that they had passed on the more difficult European sites as well as the other US sites. On the other hand, adding these sites may reflect the expectation they will almost certainly be adding 25 patients in multiple types of cancer due to early efficacy signs and will need more capacity to add patients. It would have been nice of the company to give us some hints about that on the call last week, if it is accurate. Third, Paul has emphasized the need for Christian to step up enrollment on two occasions I am aware of over the last few months. So, I began to think recruitment is an issue but again could be good news or bad news. Good news if they anticipate needing a lot more paitents due to multiple protocol amendments stemming from good early results and bad news if they are just struggling to find patients. Fourth the trial's timeline has been lengthened. Again, this could be due to good news or bad news on the recruitment front. But without any clarity on the subject from management it is typically best to assume the bad news is more likely. Fifth, TH has not yet reported anything from the phase 1b trial which indicates either enrollment is going well and efficacy is not being seen or enrollment is going poorly so they don't have enough patients yet to make any efficacy claims.
Safety has been raised as a potential issue too. I am less worried about that at this point since TH would be less likely to incur the costs and hassle of expanding the number of testing sites if TH had meaningful safety concerns.
The Chief Legal Counsel's unfortunately timed share sale in late July also is a piece of evidence to consider in this. And there is other pieces of evidence, both good and bad too as some have already pointed out elsewhere.
So, for me, while acknowledging their is a favorable case to explain the murky situation on enrollment, I am leaning toward a negative interpretation until the company clears the situation up. Had TH focused the third quarter press release and conference call on TH-1902 and had they again mentioned they think they might have "the key to unlocking cancer cells" and that "a few, several or maybe many", I would have been more encouraged. That they chose to only regurgitate TH-1902 announcements that had been previously made in the Q3 press release was a change in course for how TH's messaging was headed before the Q3 press release and one has to wonder why. Unless the preclinical work was really done poorly, we still have reason to believe the ultimate outcome will be good on some level for TH-1902 and the preclinical work they highlight at this conference this week will likely suggest the applicability of TH-1902 is going to be very broad. Nevertheless, in my view at least, the risk of TH-1902 falling short has risen as a result of last week's events. I still think it becomes something quite meaningful in the cancer field, but the probability of that being realized has dropped some based on their comments and their lack of certain comments.