Very nice presentation, well done. Very nicely explained. Thank you for Sharing.
It is true that attitude is very critical to innovation implementation.
Feasibility Assessment forms are meant to streamline processes and understand basic site features, resources and protocol related experience. Pre-Study Visits should complete the evaluation and are the ones used to make a final decision that must be based on real information about the site as received by the CRA responsible for this evaluation.
Attitude, as prior good experience with the site or excellence in performance with prior protocols is not always easily conveyed because it is subjected and the site may be new to the CRA. Likewise the implementation of new technologies or innovative ways to conduct research may not be easily revealed. This is why having a conversation about previous difficulties and specific concerns that sites may have about implementing the study is a good way to detect their approach and attitude to the identification of risk and planning resolution.
As you do more presentations more to other topics it may be interesting to see a) the new challenges that studies with big virtual/ or direct-to-patient components pose
b) the barriers to fully decentralized implementation around the globe (Regulations, medical responsibility, data protection, logistics, connectivity open access, remote SDV access, and remote ISF) How much of this is reality and how much is on a wish list but we are not yet there?
Just some ideas !!
I suggest you submit a proposal to present at ACRP2022!! Check:
Have a great day!
Very comprehensive discussion and diverse topic covered on DCT and remote monitoring. May be the next thing we should look at are the legalities and nuances of performing such remote trials and possible challenges that might arise on the regulatory side. Overall the opinions have come from personal experience with trials dealing with and is a very interesting topic to broaden
I would want to hear more from the regulatory side. Thanks