The Site Burden: Issues that Matter to Sites and Patients

Wednesday, May 25, 2022, 12:45 PM - 2:00 PM

Facilitated by Trevor Cole, Senior Manager, Client Delivery - WCG Avoca and Brigid Flanagan, Subject Matter Expert - WCG Avoca Let's talk about the reality that is site burden. We are not talking about minor inconveniences. To quote one clinical oncologist's tweet: “Apparently PI training for the latest study involves drug storage, ordering, shipment etc..etc. As these are delegated tasks, I need to know how to do them myself. What a waste of time...stopping actually treating patients. Isn't it time researchers said no? “ Another oncologist tweeted in response: “..the bureaucracy of pharma trials is totally out of control. Maybe physician QoL should be an endpoint too?” Joking aside, ICH E8 R1 encourages Sponsors to seek input from key stakeholders (PIs, RCs and patients) during study design and advises that the patient perspective be used to determine endpoints that are meaningful to them. Yet QoL is seldom a primary endpoint and the QoL results are rarely published in the primary publication of trial results. Join us for a discussion on issues that matter to sites and patients. In this 1 hour and 15-minute breakout we will explore the reality of site (and patient) burden and will focus on factors that are critical to quality for study design and study conduct.