Patient Centric Sampling Implementation in Paxloid Clinical Development

Patient centric sampling is an important element of decentralized clinical trials (DCT), a novel approach taken by pharma industry to clinical trials conduct. The purpose of DCT is to reduce burden on patients, make study more accessible to the participants, increase diversity and equity of the trial, and improve patient’s enrollment and retention rate. Patient centric sampling can be accomplished by collecting samples either at patient home or a diagnostics laboratory in the local patient community. At patient home sample collection could be done by visiting health professional, trained caregiver of as a self-collection, based upon the type of sample and sampling technique, and trial logistics. The self-collection is a rapidly developing and enabled by new technologies and devices. In amid of COVID-19 pandemic it became a necessity to limit patients visits to hospitals and minimize their and clinical personal risk of infection. This presentation is focusing on the implementation of the Tasso M-20 device in clinical development of PAXLOVID, an oral antiviral drug for the treatment of mild-to-moderate COVID-19 in adult patients with positive results of direct SARS-CoV-2 viral testing. The at-home sampling using home health visits or self-collection complemented venous blood sampling on Day 1 when the patients were in clinic to receive the first dose of the investigational product and drug supply for 5 days of treatment.
The bridging strategies were implemented between matrix type, site of collection, sample volume, etc. The results demonstrated comparability of the drug concentrations and PK data obtained in plasma and Tasso dried blood. The analytical technique, samples logistics, stability data generated to support sample and data integrity, the implementation challenges from clinical development and operations perspectives, and remaining challenges are discussed in the presentation.