Dear all,
I'm looking to the possibility for patients recruited in a Phase II study to perform subcutaneous "self-administration" of a test monoclonal antibody (all active and placebo arms) with Prefilled Syringes (PFS). Theoretically, this could be a way for increasing patients' compliance and to improve recruitment rate due to the more comfortable environment, I mean by self-administration patients can avoid to reach clinical facility for receiving the dose.
This study should be planned as a classical multicentric Phase 2, multiple dose, double blind, placebo controlled, study.
Is this feasible?
Have you some experience about it?
Have you had any experience to manage a Phase 2 study in this way in the past?
Are there intrinsic risks to invalidate the study by not compliance and/or of generation of unmanageable deviations, unexplained exposure, efficacy and safety data, etc.?
Honestly, my main concerns are both GCP compliance by itself, mainly related to the inclusion of a procedure only partially controlled or not directly controlled by study responsible personnel (i.e. investigators), and of self-administration by itself, since patients are requested to administers subcutaneously by themself with possible issues about.
Many thanks for your support, any consideration is greatly appreciated!
Best
Stefano
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Stefano Porzio
CMC and Development Director
Enthera Srl
Milano
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Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my
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