The time needed to complete oncology trials has risen steadily over the past decade. One of the many factors contributing to these delays is the challenge pharmaceutical companies and CROs face in retaining and keeping patients engaged throughout lengthy studies.
In this blog, we explore how, by understanding patients’ preferences and meeting their expectations, sponsors can simplify their participation and improve compliance and retention to accelerate important oncology clinical trials.
Growing Role of PRO in Oncology Clinical Studies
While the standard primary endpoint for oncology trials is focused on survival and overall response, regulatory agencies are increasingly placing weight on the importance of Patient-Reported Outcome (PRO)-based secondary endpoints that indicate clinical benefit in terms of patient symptoms, physical function, and overall quality of life.
Since there are many options available for capturing PRO data in oncology trials, sponsors should consider a number of factors before determining the optimal approach. Among them, patient preference and ease-of-use should factor heavily in their decision-making.
Patient Reporting Preferences in Oncology Trials
To identify patient preferences for the use of PROs in oncology trials, ERT surveyed 185 people with cancer, asking their preferences on methods and frequency of reporting daily symptoms. Of the respondents, nearly all of them (95%) felt comfortable reporting on their symptoms and the majority (63%) expressed a preference for doing so in an electronic daily diary (Figure 1).
Figure 1: Majority of cancer patients prefer to use electronic diaries to report daily symptom changes during clinical trials
Capturing patient-reported outcomes in an electronic format (ePRO), can facilitate compliance by notifying a patient when it’s time to complete an assessment. In addition, ePRO tools also offer the added benefits of: reminding patients to take their medication, reporting on their personal progress within the trial, and providing educational supportive content about managing their condition. These benefits, which are available only with ePRO solutions, deliver additional motivational value to engage and help patients remain compliant.
Virtual Trial Tech Delivers Additional Patient Convenience
While the spectrum of virtual trial technology has grown over the past few years, the current COVID-19 pandemic has been the catalyst for use of this technology. The initial use case has been to maintain on-going studies, but benefits to the patient have motivated sponsors to start to adopt these technologies more broadly and suggest that they will become “the new normal” for clinical study delivery.
ePRO, as described above, is one of the more advanced virtual technologies, with over 10 years of experience in collecting patient data virtually and a body of evidence demonstrating benefit to patients in terms of convenience/reporting burden, assessment compliance, and data quality.
Another virtual technology that is poised to offer benefit to patients is virtual visits. Through use of secure, compliant teleconferencing, sponsors can reduce the number and duration of in-person site visits – a substantial benefit in the oncology population. In fact, ERT’s Oncology Patient Survey found that nearly half of all oncology patients would be happy to have a virtual visit with their doctor instead of going to a clinic, overwhelmingly citing the convenience video calls provide and the reduced need to travel to investigative sites, particularly when in pain (Figure 2).
Figure 2: Oncology patients cite convenience and reduced travel time as the most compelling reasons to conduct virtual visits instead of in-clinic (Source: ERT Oncology Patient Survey)
However, the benefits of virtual trial technologies in improving patient engagement don’t stop here. Sponsors can further simplify patients’ participation in clinical trials by enabling capture of important safety information from the comfort of their homes. Blood pressure readings captured via ambulatory blood pressure monitors and ECG readings using a 6 lead ECG device can provide critical safety information without the need for a clinic visit. While it is unlikely that virtual technology will eliminate clinic visits for oncology studies, reducing both the duration and frequency of visits through the use of virtual tools can greatly improve patient retention and engagement in the study.
In addition to decreasing patient burden and improving patient retention/engagement, some of the virtual trial technology providers also provide sponsors with access to advanced trial oversight tools for monitoring of important study metrics such as compliance. Depending on the study design, these tools can be configured to provide insights at the site, country, and study level as well as to identify patient compliance issues in near real-time, which could signal a need for refresher training and/or trigger delivery of notifications based on custom criteria for alerts. The real-time visibility trial oversight solutions provide effectively equip sites with information to engage patients and keep them enrolled in the study.
Hybrid Virtual Trials are Here to Stay
Because of the challenges sponsors are facing during the COVID-19 pandemic, these virtual trial technologies are increasingly being used and are proving extremely beneficial in ensuring study continuity and keeping patients engaged in oncology trials, regardless of patients’ access to investigative sites.
By offering cancer patients the tools they prefer and meeting their expectations, sponsors can eliminate obstacles and keep patients better engaged, motivating them to remain compliant – all of which can go a long way in accelerating oncology clinical trials.
Elisa Cascade is the Executive Vice President of eCOA at ERT.