Cancer Trials Move Forward, Despite COVID Challenges

Despite the many challenges that biopharma is dealing with in the face of COVID-19, significant clinical development continues to move forward. G1 Therapeutics, a clinical-stage biopharmaceutical company, is on track to launch a new oncology therapy, trilaciclib, next year to improve outcomes for people treated with chemotherapy. G1 Chief Operating Officer Terry Murdock discusses how the company is navigating the evolving COVID-19 environment.

Moe Alsumidaie: What clinical trial challenges did you experience with the pivotal Trilaciclib study? 

Terry Murdock

Terry Murdock: No significant challenges outside of what you would typically find in the course of conducting those trials. In one case, we enrolled several months early, so we were very fortunate not to have some of the usual hiccups you see in trials.

Outsourcing was and still is a critical component of our operating model. This is where it is critically essential that selection of outsourcing partners is a bottom-up versus top-down decision, and you have 100% assurance that teams are compatible, build-out shared goals, and be sure that those responsibilities are clearly defined. There must also be excellent communication between all parties.

While our team was small, all were very experienced in conducting clinical trials, each with 10-15 years of experience, and they were comfortable working in an outsourced model for core clinical trial services. During the course of conducting the clinical studies, we were able to build out our internal team in parallel with that. By the time I joined the organization in August 2017, we had gone from three people dedicated to clinical operations up to nine, so we had tripled the size of our team in two years. 

As a clinical-stage biopharmaceutical company, we are not burdened by having to navigate extensive infrastructure and rigid processes, and that helps us adapt quickly and make rapid decisions and change directions rapidly. Those factors all played a crucial role in helping us overcome any challenges. We also scaled up manufacturing of trilaciclib to meet the demands of the clinical study  which has positioned us well that upon approval there will be no delay in making it available to patients.

MA: You have other therapies in the pipeline and clinical studies planned or underway. How is COVID impacting cancer trials? 

TM: Indeed, a global pandemic is disruptive to cancer clinical trials. We saw the challenges from quarantines, site closures, re-deployment of medical staff to care for COVID-19 patients, and travel limitations. I think the fact that patients with cancer having an impaired immune system raised many concerns regarding safety and getting patients to investigative sites.

It was good to see the FDA, EMA, and MHRA responded quickly and issued guidance, reminding us all that patient safety was paramount as we navigated the challenges. With patient safety as the driver, we worked closely with our outsourcing partners and have navigated these challenges well, enabling us to keep our studies open to enrollment. This was greatly facilitated by the fact our study sites are in different regions of the world, and peak COVID infections were at different times for each region so we could adapt accordingly. We also had the knowledge of our outsourcing partners and the fact they had individuals and local staff on the ground in those regions that were giving us real-time updates on the challenges for each region. That allowed us to adopt measures almost specific to sites and specific to regions. 

What we found is that there is no one-size-fits-all solution that we could put in play and fix everything. We had to handle each geographic region separately, and solutions were customized depending on the particular challenges of those investigative sites. It requires continued attention to make sure we stay on track, keep patients safe, and that we are creative in working with investigative sites to find solutions to these challenges.

MA: How do you anticipate monitoring these studies, and how do you incorporate decentralized trials when designing these new studies?

TM: I have been doing this for 25 plus years, historically, clinical research was focused around an investigator site, and you had to get the patient to that site to allow them to participate and to have all the services available to them that they needed. Now you see the focus shift to, how do you get all these services to a patient who is at home? A lot of these solutions such as telemedicine, eConsents, the ability to ship investigational agents directly to the patients, incorporating wearables or connected devices, home health visits, remote monitoring, risk-based monitoring-they have all been around for a while, but the uptake was slow. We were stuck in our old ways of doing traditional clinical research. COVID has accelerated the adoption of these solutions. This has helped us find ways to keep patients on clinical trials and keep the research sites engaged.

MA: Tell me about some of the risk assessments that you are creating in this new environment, and what strategies do you plan to implement to mitigate these COVID related study risks?

TM: The strategic outsourcing partner we chose for core clinical services is on the cutting edge of delivering what we call patient-centric research, and they have much experience doing so and have been pushing the envelope for many years. COVID brought this to light and brought these solutions to the table as a way to move forward. 

We also need to listen to the patients; listen to the challenges they have and make sure we are incorporating that into the design of our trials. All the things we have discussed-remote monitoring and other solutions-you have to take into consideration, but cancer trials are probably some of the most sophisticated studies that you can do.

You must assess the design of the trial, consider the safety profile of the investigational agent, and in the end, complete a risk assessment and customize a hybrid approach to deliver the trials.

There is no one virtual solution you can implement. You must customize it related to the geographic regions you are working in and come up with a hybrid that is going to work well for that study. 

MA: How do you think the pandemic will change the clinical development landscape moving forward?

TM: The pandemic has challenged every business in ways that we have never seen before, but I do think one positive outcome of this is it is going to transform clinical research. There is an opportunity to address the burden placed on oncology resources from the inefficiencies that have existed for years in clinical research. Ever since I started doing this work, we have talked about these challenges. The changes we are now forced to make are making a difference. You can see now there is an interest and a desire from all parties involved to make these changes. I think it is going to have a huge, positive impact for patients to access clinical trials and new cutting-edge therapies from clinical trials.

I have the privilege of being the chief COVID officer at G1 Therapeutics, and these are challenges we face every day, but everybody has come to the table and really defined what's important to the sites, what's important to the patients and are coming up with creative solutions. The regulatory authorities have been great working with and guiding sponsors. You can see there is an invested, keen interest in making all these changes endure because they are going to benefit clinical research long term, and I think it makes it more efficient for everyone.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.