When Trials Can’t Go Virtual: Conducting Phase 1 Clinical Trials During the COVID-19 Pandemic

The onset of the COVID-19 pandemic has accelerated the adoption of “virtual” clinical trials by the drug development industry, also requiring service providers to quickly pivot their offerings to one which emphasizes conducting trials in this manner instead of traditional models. In just a short period of time, companies have changed the way they do business, encouraging options for conducting virtual trials such as: E-consenting, remote monitoring, telemedicine and at-home visits. However, several trials carried out during Phase 1 through Phase 4 of a clinical development plan still require “hands-on” clinical trial provider contact with the study participant in either an in-patient or out-patient setting.

This webinar will primarily focus on the management of study volunteers participating in Early Clinical Development (Phase I) clinical trials. In order to gain confidence from Investigational Review Boards and study sponsors to proceed with a trial safely during the COVID-19 pandemic, a Phase 1 service provider must modify their work procedures and reconfigure the clinical pharmacology unit in a manner which protects both study participants and clinical operations personnel.

In this webinar, WCCT Global, a CRO dedicated to Early Clinical Development, will draw upon experienced gained within its Phase 1 clinical pharmacology unit in order to present a stepwise approach for conducting trials under these conditions, including:

1)     Establishing a validated COVID-19 testing platform

2)     Implementing safety measures to protect study participants and staff

3)     Strategically resuming clinical trial operations

4)     Creating a “decision tree” to address varying trial scenarios

5)     Setting a framework for COVID-19 surveillance

WCCT will also review case studies and data generated from trials that have been conducted at its clinical pharmacology unit in Cypress, CA. Specifically, the early phase CRO will highlight how trial operations have been adapted broadly, as well as how specific trial types (in-patient, out-patient, hybrid) have required unique considerations and approaches in order to achieve successful execution.

Speakers

Mel Affrime, PharmD, President & Chief Scientific Officer, WCCT Global

Mel Affrime has an extensive background in global clinical research and development. Following completion of his PharmD training at PCP&S in Philadelphia, he completed a Clinical Pharmacology Fellowship at Temple University College of Medicine.  He then co-founded the Clinical Pharmacology research unit at Hahnemann Hospital, Philadelphia, PA with David Lowenthal, MD, PhD in 1976.  He remained on the faculty at Hahnemann until 1982 when he joined Hoechst-Roussel Pharmaceuticals as Associate Director, Clinical Pharmacology. In 1985, he joined the Schering-Plough Research Institute as Director, Clinical Pharmacology.  During his 16 years at Schering he managed the early development programs for the entire Schering pipeline and was named VP, Clinical Pharmacology, Clinical Research in 1996.  Mel left Schering in 2001 to Join Novartis Pharmaceuticals as Global Head of Profiling Clinical Pharmacology. He was at Novartis until 2006 when he joined ICON Development Solutions as Sr. VP and Chief Scientific Officer. He remained at ICON until 2011 where he managed the medical staff at ICON’s 3 CPUs, the Population PK software business and the R&D department. Affrime Joined WCCT Global in August 2011 as Sr. VP, Translational Medicine and was promoted to President & CSO by the Board of Directors in October 2019.

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David Nguyen, MD, MBA, Chief Medical and Operations Officer, WCCT Global

Dr. David Nguyen is an anesthesiology-trained principal investigator. He has provided anesthesia for all major inpatient surgical specialties including neurosurgery, cardiothoracic, and obstetrics, as well as outpatient procedures and GI services. He is intimately familiar with transfusion medicine, fluid management, infusion reactions, and emergency anaphylactic airway response. He has also treated chronic pain patients, which gave him a first-hand account of both the opioid crisis as well as the frustrations and poor quality of life for a patient suffering from chronic pain. This impetus drove Dr. Nguyen to research the burgeoning medical cannabis field for patients and has since become a patient advocate for responsible medical cannabis use. He has given a number of “TED”-like talks outlining the medical benefits of cannabis, as well as panel discussions with community leaders about the endocannabinoid system and its effects on improving quality of life. He joined WCCT with the goal of pushing forward more high-quality pharmaceutical therapies for patients and leverages his diverse training and experience to ensure subject safety on all trials. Dr. Nguyen received his MBA with an emphasis on healthcare. Prior to joining WCCT, he founded his medical aesthetic practice “Dr. Dave’s Dermal Institute”, where he functioned as both medical director and primary practitioner. His clinical knowledge expanded to include dermatology and regenerative medicine. He brings the same customer-focused approach from this practice to volunteers in his clinical trials, ensuring subject satisfaction at all levels.

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