Article contributed to PharmaLeaders by Edward F. Ikeguchi, M.D., the Chief Executive Officer at AiCure
Most of us have personal experiences with cancer, whether ourselves or with loved ones. We know that cancer is frightening and that treatment regimens can be stressful, exhausting and overwhelming. Patients participating in drug trials for oncology are subject to a list of complex requirements that tax them physically and emotionally. While these patients do tend to be motivated – both out of a desire to improve their own health and to help other patients with the illness – the daily grind of their treatment plan regimen can wear them down negatively affecting their health and wellness and resulting in poor medication adherence or even study drop-out. This becomes a huge problem for sponsors and sites alike, as decreased adherence and fluctuating enrollment slow studies down and risks data quality. With this in mind, we can see why the average clinical trial success rate for new oncology drugs is only 3.4% while the pipeline of new oncology drugs has grown by 63% since 2013. If we can make trial participation fit more seamlessly into the lives of patients, we can work to keep patients engaged and provide the support they need to stay enrolled and compliant.
Improve Patient Access, Engagement, and Data
Improving access to tools that allow patients to manage clinical trial responsibilities easily goes a long way in keeping patients engaged in studies. One way to do this is through the use of applications that run on the patients’ own smartphones or similar devices. Think of this as a “helper” in the patient’s pocket. Using their device, patients can use apps capable of helping them stay on track with their medications and the overall treatment plan. Highly complex oncology treatment regimens can be uploaded into an app by the care team where they are simplified for participants. Patients can receive reminders for dosing and other tasks, along with easy-to-follow instructions on how to take medications. Because cancer patients often take multiple medications, this technology can be configured to account for and, most importantly, track any background medications and how they may interact with the study drug. This helps study teams identify adverse events or unexpected changes in symptomatology and intervene when necessary.
Solutions like this also enable and facilitate remote assessments, allowing patients to remain in constant contact with clinicians and reach out with any questions or concerns that arise. This is a tremendous benefit for oncology patients, who are often immunocompromised and may need to avoid clinical visits to prevent the risk of hospital-acquired infections or, of course, COVID-19. These remote capabilities include virtual visits, targeted questionnaires and electronic patient-reported outcome (ePRO) assessments, among others.
Site Benefits of the Patient-first Approach
In an effort to safeguard statistical significance and prove a drug’s efficacy, many studies plan for a certain (sometimes high) percentage of drop-outs by over-enrolling patients. While good intentioned, this approach is highly inefficient. It adds a significant amount of work for site-based study teams, as they are tasked with managing potentially huge numbers of patients, many of whom may never perform study requirements at a high level. More importantly, these approaches ignore the real challenge and provide no insight into those patient behaviors that impact study performance. Again, these patients are experiencing a wide range of responsibilities related to their study participation along with the very real physical and emotional stressors that come with it.
Implementing technology tools that streamline patient participation also benefits study sites in many ways. The ability of site teams to effectively monitor and manage patients remotely makes a big difference in whether or not that patient remains adherent and enrolled. For example, data collected through these technologies can be shared with the site very quickly, and solutions can be configured to alert site leaders when certain events occur, such as missed doses or a side-effect report. Doses can be recorded and confirmed in the same application and uploaded immediately to the study database.
Patients and site support staff can interact and engage with each other through the same tools that are used to manage and monitor dosing. While the app is tracking dosing adherence, certain events might trigger a questionnaire to be sent to the patient, or a text from the site team, or even a video chat. The patient can then respond easily inside the app and site teams can review their answers in near real-time. This allows for problem-solving as well as data collection on symptom changes or potential side-effects at any time, not just during face-to-face clinical visits.
The world of clinical oncology research is only growing in complexity. It remains challenging, despite advances in technology and methodology over the years, to successfully bring new oncology therapies to market. To unlock new doors to advance oncology trial data, we need to more holistically understand patient behaviors. By improving patient compliance with study requirements, higher quality data can be attained. Understanding the obstacles that oncology patients must overcome, both physically and emotionally, we can tailor and implement tools that give them the support they need to remain engaged and motivated.
About the Author
Edward F. Ikeguchi, M.D. is the Chief Executive Officer at AiCure. Dr. Ikeguchi served as assistant professor of clinical urology at Columbia University, where he has experience using healthcare technology solutions as a clinical investigator in numerous trials sponsored by both the commercial industry and the National Institutes of Health. Dr. Ikeguchi holds a B.S. in chemistry from Fordham University and a M.D. from Columbia University’s College of Physicians & Surgeons, where he also completed his surgical internship, subspecialty training and fellowship.