Looking at all Phase III industry-sponsored trials completing enrollment between 2013 and 2017 with a sample size of 3,723, there is an average Phase III enrollment of 622 subjects per trial (ClinicalTrials.gov). It is not uncommon for studies across a wide range of TAs to have thousands of subjects and increasingly we are seeing mega-trials with tens of thousands of subjects. 124 studies in this cohort alone had enrollments above 2,000 and 28 studies had enrollments in excess of 10,000.
The need to recruit and retain these numbers of patients is not new to the industry, but there are new opportunities to achieve recruitment goals while also minimizing dropout. These tools allow for better focus on patient experience, and ultimately better trials.
Voice of the Patient
While Quality by Design (QbD) is increasingly being used as an effective tool in protocol development, and epidemiology and claims data inform feasibility and inclusion / exclusion criteria, very few sponsors engage potential subjects during protocol development, for example, sharing non-technical versions of the protocol outline for feedback and input. The fact that “protocol complexity/burden” is often defined as the burden on the site or PI is evidence enough that the industry has failed to engage the potential clinical trial population. Patient burden is key factor to recruitment and retention.
Patient Journey Maps are another useful tool that can be borrowed from the healthcare environment and applied to clinical trials to design protocols and operational processes that have the best chance of maximizing data collection from the subject population.
While the site-less trial may be more visionary than reality at this time, the use of electronic Clinical Outcomes Assessment (eCOA), wearables, and other site-remote approaches hold great promise to minimize the burden of frequent site visits by the patient while maximizing data collection.
Today’s two-way smart technologies also allow confidential site communication be shared directly between the site and the subject – and it’s more than just reminders, as individual subject data and lab results are also part of the exchange. To reap the benefits of engaging the subject as a true partner in clinical research, sponsors and sites will need to change the way they think about subjects – from passive patients to which procedures are inflicted upon, to active stakeholders.
While the dropout rate of clinical trials has historically hovered around 30%, the effects of non-compliance are, by their nature, impossible to quantify. In addition, the issue of non-compliance adds a potentially significant confounding factor.
One solution is to complement the power of digital. By 2020 most estimates of global smart phone penetration are above 50%. And in the Developed World containing the traditional Pharma Major Markets, smart phone usage is currently above 70% of the total population. Even in the so-called BRICK zone (Brazil, Russia, India, China, Korea), smart phone penetration is currently around 48%. All of this leads to the opportunity to engage subjects for enhanced compliance, not only as alarm clocks and scheduling reminders but through communication, social media strategies, and even directly observed therapy.
The phrase Customer Centricity continues to be a term that confounds, and is defined very differently depending on who you are speaking with. We’d love to hear what Customer Centricity means to you and how your organization adapting. We hope you’ll take a moment to leave a comment below.
Jeff Handen | Senior Consultant | TayganPoint Consulting Group | firstname.lastname@example.org | LinkedIn