New Parexel Innovation Center to help guide sponsor's patient-centricity initiatives
A recent report by The Economist Intelligence Unit (EIU) found that patient-centric trials recruited participants in almost half the time and that drugs developed using such approaches were 19% more likely to be launched.
Still, patient-centric designs only were used in 5.2% of Phase II and III trials across the industry, per the report commissioned by Parexel.
Read more: Drug development innovations not widely adopted, despite benefits
The Patient Innovation Center will offer services including study planning and implementation as well as patient and market access.
Rosamund Round, patient-centricity and innovation lead, Parexel, said the center was developed to provide “a focal point” for the company’s patient-focused activity, noting that it will help the company continually improve its patient-centric activities.
“We are also committed to innovating in this area, as there is always more to be done to optimize the patient experience,” she told us.
The center will provide “guidance, support, and collaboration as the industry continues to put the patient at the heart of clinical research,” Round added.
While industry stakeholders agree that more needs to be done in terms of patient-centricity, Sy Pretorius, senior vice president, medical and scientific services, Parexel, commented that many still have questions about where to start. The new center aims to be one potential answer.
Industry initiatives
As Round explained, among the industry’s initiatives is to involve patients and caregivers in the study design process. “Usually, the feedback we receive is based around practical, geographical and financial barriers to participation rather than simply what is in the eligibility criteria or schedule of assessments,” she said.
Round explained, “Covering childcare, taking time off work or school, and the availability of transportation can be far more problematic for study participants than medical tests or procedures, so we need to be attuned to that in order to create study protocols that fit with patients’ lives.”
The main challenge is usually timing, she added, noting that patients should be included from the onset of trial planning to ensure feedback can be incorporated into the protocol design.
Other initiatives include the shift towards virtual or “at-home” trials. “Virtual trials really are the epitome of patient-centric trials as everything is designed with their needs in mind,” said Round.
While virtual trials work for many studies – and are particularly useful in rare diseases in which patients are spread out geographically – the design is not applicable across the board. As with any innovation, Round said the main challenge with implementation is helping customers feel comfortable taking a new approach.
Moving forward, Pretorius anticipates that the patient-centricity trend, and incorporating patient-centric approaches, will continue to grow. Citing the EIU report, he explained there is “a lot of runway for higher adoption.”
“I also anticipate that virtual trials and the use of sensors to collect data in the comfort of the patient’s own home and in a real-world setting will continue to gain traction,” he added, noting that this is a significant focus area for Parexel. Pretorius also anticipates a shift towards endpoints that are valuable to patients.
“As an industry, we need patients in order to advance new therapies,” he said. “We need patients to be interested in clinical trials, to participate in clinical trials, and to be vested in the clinical trial process.”
