“We all had a flurry of unprecedented activity,” explains Nicole Connelly, Senior Director of R&DS Strategy and Innovation at IQVIA, about the company’s efforts to grapple with the COVID pandemic. “We were assessing risks to patients and data, and putting in place mitigation strategies to preserve continuity of the studies.” Those strategies involved thousands of amendments to protocols, adapting to sudden changes that impacted patients and sites around the world. COVID forced IQVIA to ask how the company engages around data in general, how to engage with sites in a different manner, and what happens when staff can’t be on site.
Technology solutions are playing a central role in the tectonic shifts during this time of crisis, and enabling IQVIA to envision holistic, virtual access for trials of the future. The ability to deliver medicines directly to patients or implement protocols that use virtual patient visits, helps patients continue to access leading-edge care. But it also improves trial continuity and data integrity – improving flexibility and resilience.
Those same technologies enable remote source data monitoring techniques due to the advancements in access to data sources. During the COVID-19 pandemic, having options to do remote source monitoring and interacting with the site personnel, data and documents has been vital for trial continuity and continuing study progress. No matter if a monitor is on-site or off-site, there is continuous access to the data via technologies such as Electronic Medical Records (EMR) and electronic consent forms. When Risk-Based Monitoring (RBM) is in place, there is an easier transition to remote solutions, as RBM-by-design relies less on on-site data verification and incorporates remote visits as part of the model, thus facilitating access to the site and data in a continuous manner.
While sponsors, CROs and regulators permitted trials to be adapted amidst disruptions like COVID, several hurdles still exist for this to be accepted permanently. IQVIA sees the COVID era as illustrating an urgent need for the industry and regulators to make that shift and implement remote technologies as the new “business as usual.”
Remote technologies also have great potential to reduce the cost of trials and to allow for a much more flexible way to interact with sites and review data over the life of a clinical trial. IQVIA looked at an example of the potential savings of reducing the amount of time on site. If the industry could eliminate ten onsite visits per trial each year, the clinical research enterprise would save over $250 million on travel alone. “Remote data monitoring impacts every trial and every site,” says Eran Gordon, Senior Vice President of Operational Transformation & Performance at IQVIA. “That’s where we can have a huge impact.”
If we imagine a post-COVID world with a blend of onsite and remote visits as well as direct to patient and at-clinic visits, we enable much more flexibility for trial participants and investigators. This has huge potential to reduce the cost of clinical trials by lowering the overall costs of clinical monitoring expenditures. More importantly, direct-to-patient solutions have the benefit of increasing patient participation and the quality and diversity of clinical trial patients, as well as driving enrolment in trials. All these advancements help bring new medicines to patient communities faster, improving health outcomes.
Direct patient access, decentralized trials, and studies with a combination of remote and on-site monitoring are part of IQVIA’s vision for clinical research in a post-COVID era. 2020 shows us that the new normal is not only possible, but necessary.
This is Part 1 of a 3 part series. Next: Part 2 – Preparing to be on site less
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