RE:RE:RE:RE:RE:Finally listened to call@Joe. How many people on this board have actual experience with the TH1902 trial? It is basically me,and maybe Rusty a small amount with his cousin
They are expanding into other countries because it is worthwhile doing. That in itself was a go/no to decision. I had the discussion with Christian about why Canada was not going to have sites initially. It has mostly to do with paperwork (which is very cumbersome in Canada) and Thera wanting to get things done as fast as possible. Involving Canada and the EU for the 1b part of the trial was always in the plans from the beginning. Nothing to do with enrollment. But now it seems it is worthwhile to continue with the original plan to expand to Canada and the EU, which won't be cheap.
Why do you assume that Christian does not meet with the lead investigators? He meets with them weekly. I spoke to many nurses about the TH1902 trial, they were actually frustrated that they could not get more patients on during the 1a portion of the trial. But they are very happy to be able to get more patients on now. I don't believe enrollment is an issue. It is just an assumption that people here are making to come up for explanations as to why a big efficacy announcement has not been made. Well this is Thera, get used to it. They will communicate when they feel like it.
Joemare wrote: When you add countries, it means there's an issue with patient accrual. So late in the game to involve Canada and the EU is somewhat due to a lack of a) competency in clinical trial mgmt and b)executive leadership.
Are they using a CRO to conduct the clinical trial? If not, why not??? If so, fire them. Use a better one. Tons out there with P.I knowledge
They need to get the prinicpal investigators, the study coordinators, nurses pumped up to recruit patients. How many times did the VP and P meet with these clinical invesigators???