By Cristian Massacesi, Senior Vice President and Head of Oncology Late-Stage Development
Participating in clinical trials has many benefits for patients, but requires a significant commitment of time and energy. Patients often need to be prepared for countless clinic visits, medical tests, questionnaires, and more. Simply getting to and from required appointments takes time and can sometimes involve traveling long distances. On top of this, many patients are dealing with physical and emotional challenges related to their illness. This is particularly true for patients in cancer clinical trials, many of whom are navigating long and difficult treatment journeys and may be unable to summon extra time or energy to participate in a trial.
With the outbreak of Covid-19 and the onset of global lockdowns, conducting and participating in clinical trials brought further challenges and added significant logistical complexity. The safety of patients remained the number one priority of everyone involved. One year into the pandemic, we are now getting a better sense of how trial designs have evolved, and long-term benefits from these changes are emerging. It is clearer than ever that innovative digital healthcare solutions can bring about a better clinical trial experience for patients and investigators alike. We have witnessed an acceleration of this digital revolution as a response to the pandemic, which has not only allowed us to continue developing much-needed new treatments for patients with cancer, but also ushered in a new era of patient-centric clinical trials that will become the new standard.
Digitization of trial design from the start
Well before Covid-19, we at AstraZeneca were already transforming our clinical trials to simplify participation and enable patients to complete more checks at home using digital tools. We began by evaluating potential barriers to trial participation to introduce digital solutions into every possible part of our study designs. This initially focused on what elements could be done remotely. With virtual visits, non-invasive data collection and technology that monitors patients in their homes instead of a hospital setting, we were already reducing the number of clinic visits needed. After scrutinizing more than 90 trial protocols, we concluded that up to 70 percent of patient data could be collected remotely, and so began steps to make that possible. We also challenged our assumptions: what data are absolutely essential to collect at a hospital, and what data could be collected from the patient’s home? How can technology help provide data when patients’ travels are limited or restrictive?
Acceleration and adaptation during Covid-19
Our pioneering ways certainly proved to be a significant benefit when the pandemic hit. Implementing the new digital advances during a time when our resources were being stretched in many different directions was extremely challenging, but we were at least one step ahead of the need for new trial designs to keep patients safe. We knew that cancer would not stop even as the world locked down, and we owed it to patients to find every possible way to continue with trials and their treatments. Our group of passionate scientists formed an “Oncology SWAT” team to accelerate new processes that would allow safe participation for patients and continuous monitoring of their health and well-being.
We increased the use of local and telehealth data collection, electronic consent, automated home delivery of medications, and user-friendly apps that monitor vitals and automatically report any issues like adverse events or disease progression to the clinic. Within weeks, patients in our clinical trials were able to complete many required activities from home — tracking their health in real time, reporting their own stats through electronic devices, holding remote meetings with their doctors, picking up investigational medicines from their mailbox, and more. In Brazil for example, we worked with our trial collaborators to introduce at-home testing to check patients for cancers with EGFR mutations, which has now been replicated in other countries. In Russia, retrospective lung cancer screening allowed Covid-19 scans to be analyzed using artificial intelligence to determine if signs of lung cancer were present, without requiring another clinic visit.
Driving digital solutions beyond “at home” options
AstraZeneca’s digital solutions go beyond remote capabilities. They are helping us analyze large swathes of existing data to refine patient selection and enhance the way we identify and recruit patients. We closely track recruitment and any emerging trends within patient sub-groups to react quickly if changes need to be made. Enhancements to patient-level remote monitoring can also help identify in advance any patients who are at risk of being lost to follow-up, so we can contact their trial site and adjust their personal care as needed. We also are using technology that helps those local sites with operations, including coordination of drug shipments that can be sent to the sites and then easily couriered directly to patients.
Last year, AstraZeneca launched two clinical trials adopting innovative technology to detect cancer signals before relapse, with the ambition of transforming the way we treat lung cancer. We will measure the levels of circulating tumor DNA in the blood to detect minimal residual disease — to identify patients most at risk of relapse after surgery, and potentially intervene earlier with treatment. We’ve also implemented remote monitoring protocols in these trials to more efficiently review clinical trial data, ensuring the collection of high-quality data to more closely monitor patient safety and any adverse events in real time.
These are just some of the ways we’re reducing the time commitment for patients and investigators, and improving the trial experience — with the objective to run our trials more efficiently and get potential new medicines to patients more quickly.
Continuing the momentum to improve trials and reduce burden
The digital healthcare transformation is creating new opportunities to change the face of late-stage (Phase 3 and beyond) oncology clinical trials — no question. Technology-led solutions to historical issues are being discovered for every stage of a clinical trial’s lifecycle — from study design and selection, through site activation, to recruitment, monitoring, and reporting. These advances were critical during the last year for AstraZeneca as we faced significant operational challenges brought on by the pandemic, and they are here to stay. Having these digital solutions at the ready, and the ability to rapidly ramp-up many of them, meant we were able to continue the vast majority (~80 percent) of our late-stage cancer trials with minimal delays or disruptions. We continue to push this digital evolution to the next level to make clinical trials increasingly patient-centric, while reducing burden for investigators too. This pivotal moment for improving cancer care and clinical trials for patients is just the beginning.
Read more about how we’re harnessing data and technology at AstraZeneca to lead a revolution in oncology and redefine patient care. And find out more about AstraZeneca’s commitment to the global cancer community through the New Normal, Same Cancer initiative to raise awareness about the impact of Covid-19 on cancer treatment and screening, to ensure continuity of care for patients around the world.