It was a familiar scenario: A rare disease area of oncology. A new drug candidate. A desire to assess efficacy as safely and quickly as possible, so that if successful, a new therapy could get approved and change lives. But this desire could have been tempered by reality: the trial was going to be challenging and slow…
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 speeding the development of new medicines.
Diverse technology solutions, like patient telehealth visits, accessing electronic medical records (EMRs) or remote source data verification, can generate vast amounts of data. As the clinical research industry evolves towards its next “new normal” with a higher baseline level of remote monitoring, IQVIA is considering the implications of increasing data access. Are we ready?
We all had a flurry of unprecedented activity. 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.
A key pillar in the COVID-19 battle is the rapid development of a safe and effective vaccine. As vaccine R&D shifted into gear and then accelerated throughout 2020, with a rapidly growing number of candidates, platforms and manufacturers, it appeared that a bottleneck in this race could actually be the ability to enroll participants.
In the 10 weeks following the US’ declaration of a pandemic crisis, hospital ER visits declined for conditions like heart attacks and strokes. Simultaneously, based on clinical trials in the Medidata ecosystem, new subject enrollment declined 30%. But also in that time period, ER visits related to uncontrolled high blood sugar saw less of a decline. Patients continued to seek care. Why?
“There’s a global sense of urgency,” says Jamie Macdonald, CEO of Parexel, of the collaboration between stakeholders to accelerate development. One key focus for Macdonald is the lengthy process of trials, and compressing that “dead space” to shorten timelines, improve efficiency and quality.
“The pandemic has changed everything about the pace of our innovation and our focus,” says Peyton Howell, EVP and Chief Commercial & Strategy Officer at Parexel. There used to be lots of caution around using real-world data and evidence, but this year has illustrated the need for new paradigms.
For Dr. Sy Pretorius, Parexel’s Chief Medical & Scientific Officer, COVID-19 has been a catalyst. The pandemic has accelerated innovations that make it easier for patients to participate and for sponsors to conduct research. Parexel has seen increases in decentralized trials and remote monitoring, where study designs were adapted amidst the pandemic.
On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.