For the clinical research industry, technological tools improve trial continuity, and generate data that helps power more robust monitoring of safety and quality. They can also be a natural fit for patients. IQVIA also sees study participants liking the direct shipment of medicines, telehealth interactions and at-home visits.
In the COVID era and beyond, designing more trials with these kinds of technology-enabled strategies is going to help more people by lowering barriers to participation, and making trials accessible to traditionally underrepresented populations, and speeding the development of new medicines. Harnessing technology and data becomes a fundamentally patient-centered approach. And improving patients’ lives is what clinical research is all about.
Over the past two years, IQVIA has worked with Tufts University’s Center for the Study of Drug Development to develop a metric known as the “the patient friction coefficient.” This metric can help assess which burdens are impacting recruitment and retention, enabling trial designers to make shifts that ease those frictions.
The sudden increase in use of technological tools also reveals challenges, such as gaps in the regulatory landscape around remote monitoring of site and patient data. But these challenges give the industry more motivation to drive much-needed evolution. Rachael Fones, Director of Government & Public Affairs at IQVIA, is thinking about the implications of tech enablement, not only for the next crisis, but also the new normal. “We’d be remiss if we aren’t planning to these efficiencies and contingencies into future programs. We all have to be ready to pivot again to ensure patient safety and data integrity are maintained.”
For IQVIA, new trials are seeing more use of remote monitoring. This shows that sponsors, sites and regulators are adopting new methodologies but are also employing new technology to de-risk trials in the future. “The pure level of protocol amendments, regulatory submissions and changes to SOPs to maintain trial continuity and compliance – it was herculean,” says Fones. “It would be a shame if the whole enterprise’s focus on doing better for the patient and innovating in bringing research to them is something that gets lost by not re-imagining how we conduct clinical research.”
Read more about how regulatory action was a critical catalyst to patient-centric changes to trials in the COVID-19 environment in this Blog post that asks: COVID-19 has forever changed clinical research. Will it also forever change regulations?
This is Part 3 of a 3 part series.
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