Early Phase Clinical Trial Development

Thanks for the response, Christopher O'Toole. In my experience, I've seen sponsors incorporate patient feedback starting in Phase II/III, as Phase I focuses solely on safety and PK/PD.? I published an article on how emerging biopharma companies are leveraging patient-centricity [1], and based on the information from this article, sponsors incorporate patient feedback to make studies more convenient for patients. However, I've seen the definition of patient centricity span to other areas and from different parties (i.e., FDA, Sponsors, and Vendors) ranging from developing clinically meaningful outcomes, and designing very focused protocols to making studies more convenient, and involving patients through the clinical trial journey through materials and engagement and digital technology [2]. I covered the evolution of patient centricity in my second article. I hope this sheds more light on the topic. [1] https://www.appliedclinicaltrialsonline.com/patient-centricity-improving-study-outcomes-small-pharma [2]?https://www.appliedclinicaltrialsonline.com/evolution-patient-centricity

Interesting article and thanks for sharing. I've not had much involvement in early phase trials but assumed that sponsors were always responsible for resolving issues that arose from phase I trials. If not them, who? Also interested in any thoughts on when patient involvement is sought into trial design. Not protocol development per se, but general input. Is phase I too early? As I speak to companies and hear panels it seems there are many now requesting patients' comments and insights much earlier in the drug development process. Thanks

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