A COVID-resilient environment and clinical trials was the topic of discussion at a virtual forum hosted by NCBIO November 19.
The concept of virtual or decentralized trials has been around for a while, but COVID-19 forced companies and the FDA to act. Biopharma, regulatory and CRO representatives shared their perspectives on decentralized trials, their challenges and limitations, and on COVID-19 as a catalyst for clinical development change.
The session was moderated by Phil Collis, Ph.D., vice president, global development at BioCryst Pharmaceuticals, and featured
- Amy Cramer, director, global product development strategic partnerships at Pfizer;
- Tina Papagiannopoulos, associate with Foley Hoag;
- Kristen Pappas, associate director at bluebird bio, and
- David Tripi, vice president, innovation and customer engagement lead at IQVIA.
Tripi started things off by sharing IQVIA’s virtual trials solutions. Telemedicine will be the way forward, he said, because patients and sites prefer it. He describes a “hybrid trial” that incorporates remote, home-based visits into a traditional site model to reduce the burden on the patient, streamline operations and reduce costs.
Papagiannolpoulous is with law firm Foley Hoag. She talked recent initiatives by the FDA to support clinical trials during a pandemic, such as guidance for maintaining clinical-trial integrity (e.g., dealing with missing data, documenting with video, remote monitoring). These new rules are only in effect for the duration of the emergency, although they could persist if they are found to promote economic recovery without adversely affecting patient safety and other FDA policies.
Pfizer’s Cramer said that it shouldn’t take a pandemic to re-engineer clinical trials, but the pandemic has provided an opportunity we’ve never had before. We should take the opportunity to create efficiencies and improve accessibility of trials. We should focus on the needs of each study and deliver what participants to succeed. Example she gave were closing the gap between clinical care and clinical research with telemedicine, allowing for location flexibility and shipping study materials to patients whenever possible.
Bluebird bio focuses on rare diseases, and Pappas said their patients couldn’t afford to have trials interrupted by the pandemic. Bluebird created a COVID guidebook that spelled out exactly what aspects of trials had to be done in a clinical setting and what could be done remotely.
In the wrap-up Q&A, the participants agreed that going back to the old ways of conducting trials would be a mistake. It will be important to collect data to show whether virtual trials increase subject enrollment and reduce dropouts, Tripi said.
Cramer added,“What patients and site want will drive the adoption of virtual trials. We're going to have to wait for the data to hopefully show that this is a positive disruption of the clinical trial model.”