For quite some time now, we know and acknowledge that the main and most important party in a clinical trial is the patient. However, even when a clinical site has been successful in enrolling the patients needed, the challenge remains in having the patient engaged and complete the study to its end.
According to Tufts CSDD Impact Report, despite that we are when it comes to enrolment, patient retention is crumbling as the trial dropout rate rose to 19.1% in late phase trials globally in 2019 from 15.3% in 2012, with the highest rates occurring in central nervous system (CNS) and oncology trials. CNS trial dropout rates grew to 25.9% in 2019 from 19.2% in 2012, and oncology trial rates grew to 19.3% from 18.2%. Vaccine trials experienced a 12.3% dropout rate in 2019. Cardiovascular and rare disease trials fared best, with rates of 7% and 6.5% respectively.
But what makes patients leave?
Patients may drop out from a clinical trial for various reasons, some being very personal, but for now, let us consider the following three.
Costs. Some clinical trials can be designed in a way that involves some costs for the patients, including the expenses associated with transportation, the loss of income resulting from missed hours or days of work, or the financial burden of study-related treatments and medications. Other trials request assessments that might not be covered by patient’s healthcare insurance coverage, resulting in an additional burden to the patients.
Long-distance travelling. Patients, especially those living in cities or who are older, often face difficulties when they have to travel a long way to reach the clinic for their patient visit or assessment. A lengthy commute doesn’t just lead to direct costs or interruptions in work hours that may not be compensated, but it also adds to the fatigue that comes with commuting.
Engagement. Often patients may feel disengaged or uninterested in the study, particularly if the tasks to do are repetitive, boring, or time-consuming. A lack of motivation can lead to early withdrawal. At the same time, patients might also not feel supported or accompanied throughout the study, which leads to fear and ultimately, disengagement and drop out.
So, what can be done?
The term patient centricity is heard everywhere nowadays, and rightly so. From designing the clinical trial protocol prioritizing the patient’s needs and experience keeping in mind challenges such as cost constraints and long-distance travelling, to also designing technology tools that truly understand the patient’s perspective, that engage the patient and tailor the experience to help the patient adhere to the treatment and comply with all protocol requirements.
Meaning, design for engagement.
Consider the example of an electronic patient-reported outcomes (ePRO) tool. A truly engaging experience within the ePRO goes beyond its functionality to create a sense of companionship and support for the patient throughout the trial journey. The patient’s achieved milestones should be celebrated and the challenges should be fuelled with encouragement to overcome them.
Even more, the patient’s opinion should be considered at all times while also informing and guiding the patient through tailored messages. Together with a transparent and constant flow of communication, the relationship between patients and healthcare professionals will grow stronger which ultimately, will enhance patient satisfaction, overall quality of care and well-being leading to fewer drop-outs, better quality data and the highest chance of reaching study timelines.