Best Practices to Improve Oncology Trial Performance

The most common challenges which our sponsors are facing on a daily basis are site engagement, study design complexities, particularly those related to visit schedules and assessments, toxicity and safety management. And finally, visibility of what sites are doing or the lack thereof. I've received a lot of student feedback and have seen firsthand the difficulty in keeping sites engaged, particularly when they're running multiple simultaneous trials. This leads to a difficulty keeping sites engaged with the study documents, and we all know the issues there.

There's also the added complexity or challenge of site staff turnover, which study teams have discussed with me before. Oncology trials typically have many visits or assessments during the trial and have a very detailed assessment or procedure list for each visit. We have seen the complexities here with the large number of protocol amendments in oncology trials and through the changes to the visit procedures inclusion criteria to make the studies more desirable for both sites. And patients.

Study teams are currently being reactive as opposed to proactive, and they only find out about issues at a site after they have happened. It gives the study team extremely limited ability to pre-empt ease and ease, and it leads to something evident in every clinical trial, not just oncology, which is a lack of visibility to see what sites are doing in real time. There is a disconnect between the study team with the monitors and sites, and this has become an even larger issue, particularly in the current climate, when site status is changing on a daily and weekly basis. And also monitors are doing remote monitoring of sites.

Well, we've seen of those that are using tech or fewer protocol deviations at site with site staff having instant access to the protocol, they can reach into their pocket, have access to the study. Documents to take will instantly take will also allow study teams to have better visibility of site activity and engagement, particularly when they can see in real time how sites are interacting with their study documents.