Prologue: Challenges and Opportunities During COVID-19 Pandemic and its Impact on Clinical Trials: A Clinical Pharmacology Perspective

Monday, October 17, 2022

8:30 AM – 9:00 AM ET

Location:151 AB

Prologue Speaker(s)

Sandhya Girish, M.Pharm, PhD

Vice President, Head Clinical Pharmacology, Bioanalytical & Pharmacometrics
Gilead Sciences
Foster City , California

Handouts

The IQ CPLG conducted two surveys in 2020 and 2021 to collect IQ member companies’ experience in the following aspects:
1. The cause and extent of missing PK and PD samples and dosing information due to the pandemic;
2. The impact of missing data and missed doses on trial results and potential regulatory implication; and
3. The strategies that were implemented to minimize missed samples (e.g., Patient centric sampling, flexible sample collection windows, mobile vendors, etc.).
In addition, development of COVID-19 treatment options were under unprecedented accelerated timelines to address the immediate public health need. The IQ CPLG survey captured from a clinical pharmacology perspective, the differences in design and conduct of COVID-19 treatment development trials versus non-COVID-19 treatment (standard trials for other treatment options) development trials.
Survey results and case studies will be discussed highlighting challenges and opportunities.

Learning Objectives:

upon completion , participant will be able to appreciate the impact COVID-19 has had on the conduct of clinical trials.
Participants will be able to appreciate the available tools and technologies and approaches to minimize the impact of the pandemic on the design and conduct of clinical trials.
Participants will also have a greater appreciation of the approaches to minimize the impact of the pandemic on the design and conduct and analyses of data from clinical trials.