February 24, 2022
A Bright Future for Oncology Research: How Sites Are Finally Finding Their Voice
Healthcare Project ManagerGuest
Oncology trials can be challenging at the best of times. Recruiting patients can be tough because of stringent inclusion and exclusion criteria. And a delicate balancing act is needed when managing studies, because as they progress, they hyper-focus on one or two diseases.
In our Phase I clinical trial unit, we enroll around 150 patients per year across over 35 active and enrolling trials for various Phase I solid tumor dose escalation and expansion clinical trials. We need a lot of studies that theoretically “compete” with each other to have a greater chance of discovering the new treatments and therapies oncology patients so desperately need. Additionally, as we consistently have more potential patients than slots available to us, our site needs multiple studies to ensure slot availability. From a patient, site and sponsor perspective, oncology clinical trials can be especially complex because there are so many different studies to manage and for many patients it is their last chance at finding a cure.
When COVID-19 arrived on the scene, we had to completely rework how we operated. The danger was that the situation could become difficult to manage because we’d never operated remotely before. Pre-pandemic, we were stuck in a paper-heavy era. Then within a matter of two weeks, we had to come up with an entire policy for how monitors could continue to monitor, how staff could work from home and countless other workflows. It was a huge shift, particularly because there was so much at stake. We had to continue to see patients and navigate keeping them safe while creating our remote monitoring system.
Luckily, we were able to successfully adapt by implementing a lot of different telemedicine visits, which required constant collaboration with sponsors regarding where we were in the trial cycle. Every sponsor managed that a little bit differently, so many of us felt pulled in a thousand different directions. Different portals, access points and workflows were introduced with the goal of improving efficiency. Unfortunately, this wasn’t always the result. Think of it this way: if you have one study with four to five portals – that may seem manageable. But if you consider that most sites have upwards of 10 studies, you are looking at 40 to 50 portals and dozens of passwords. And every study now has six or seven new amendments. That’s essentially like opening six or seven new studies!
Precision Medicine, Diversity Initiatives and the Impact on Sites
I understand that sponsors are doing their best to help site staff and that it can be difficult to fully grasp what it's like being the “boots-on-the-ground” so to speak. But trials are only going to become more complicated in the future, so it is important that site staff have the space to share our insights on how to continue to enroll the way that we need to and ensure the patient receives high-quality care.
For example, there’s currently a huge emphasis on cellular therapies, which introduces new, healthy cells into a patient's body to replace the diseased or missing ones. This is a fantastic opportunity for patients but it's incredibly complex and requires ancillary departments to be able to do the studies. Additionally, a lot of studies are also moving in the direction of specific mutations as precision medicine continues to be a significant area of interest.
And then there are the master umbrella protocols where you have the master protocol and four or five sub-studies. This is an amazing chance for patients who can enroll onto that master protocol and get a dozen different therapy options based off that one protocol – all brought to the site with just one study.
However, from the site perspective, each of those dozens of clinical trial arms or sub-protocols require the work as if each are individual studies. Master protocols can offer significant benefits, such as increased efficiency, reduced costs, a shorter timeline and streamlined enrollment. Yet from a site perspective, they can be resource-intensive and constantly evolving.
Diversity, Equity and Inclusion (DEI) is another challenge that everyone is talking about which will revolutionize the landscape of patient recruitment. But this involves a whole host of other considerations, such as how best to work with advocacy groups, sponsors and investigators to increase enrollment among underserved populations.
The good news is that site staff are beginning to have more input when it comes to protocols from both a medical and operational perspective. Sites are receiving protocols before they are finalized, which means we can share our views. Patients are becoming increasingly educated and this is very empowering because they can have a say in how trials are developed.
Site staff will play a crucial role in communicating with sponsors regarding the importance of patient centricity. This is where we need to further leverage technology for ongoing feedback and streamlined communications. The voice of sites is evolving, and this makes me optimistic for the future of both sites and patients – it’s an exciting time to be working in clinical research!
Healthcare Project ManagerGuest
Chelsea McCabe is an oncology research project manager at Hackensack Meridian Health. Chelsea has more than 10 years of healthcare experience in various aspects of medical services, and has overseen over 30 open Phase I oncology clinical trials.