|
Re: Irene From Tampa
It would seem that there is need to augment the clinical trial practice with some new process for refractory patients that no longer respond in accordance with sponsor and FDA agreed test evaluation criteria and for whom no alternative, potentially efficacious treatment is at hand, which in so many instances is the case.
And yes, that new process should definitely include option to continue receiving original drug(s) used by ongoing clinical assessment.
Not only is it possible, even probable that patients assigned to and treated in this new setting will reap more benefit from this service than being outright excluded from it, but they also continue to provide science with further data about drug’s performance when re-administered after some period of discontinuation.
|