RE: RE: RE: RE: RE: DCGiThe most likely explanation is that the intention was to recruit the maximum number of patients from India and the remainder from North America, simultaneously. The North American recruitment has lagged behind and the recruitment in India has been completed. There is no mechanism in India to allow a request for an exception to this limit.
There is a reason why SCT is in India in the first place; the trials are cheaper, there is less regulatory oversight and international clinical trials support licensing in the future.
There are ethics boards in Canadian and American hospitals that review each patient’s circumstances before permitting participation in a clinical trial - it takes time and effort. How do you think SCT was able to recruit 90 patents in India so quickly, compared to the number recruited here ? The recruitment in India was never a rate-limiting step in this trial but the NA recruitment is another story.
Obviously, maximizing recruitment in India was a strategic decision which has provided quick results for the first 75% of the trial, the rest will take a little more time.