Related Experiment Video
Updated: Dec 19, 2025
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
The World of Clinical Trial Development Post COVID-19: Lessons Learned from a Global Pandemic
Fatima Karzai1, Ravi A Madan1, William L Dahut2
1Genitourinary Malignancies Branch, Center for Cancer Research, NCI, NIH, Bethesda, Maryland.
Abstract:
The novel coronavirus disease-2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is a global health threat (1). Patients with cancer are one of the most vulnerable populations. During this pandemic, clinical trial accrual to NCI studies has fallen dramatically. Investigators quickly turned to regulatory bodies to simplify treatment schedules, facilitate telemedicine, and decrease required data collection. Going forward, the oncology research community must use the lessons learned to focus on redesigning studies to ensure that critical scientific questions are answered safely while expanding access and increasing partnerships with community physicians. These changes will accelerate clinical progress while protecting our patients.
Insights
The COVID-19 pandemic significantly impacted cancer clinical trials, reducing patient enrollment. Lessons learned are vital for redesigning future oncology research to ensure patient safety and accelerate progress.
Area of Science:
- Oncology
- Infectious Diseases
- Clinical Research
Background:
- The COVID-19 pandemic, caused by SARS-CoV-2, poses a significant global health threat.
- Cancer patients represent a highly vulnerable population during the pandemic.
- Clinical trial accrual for National Cancer Institute (NCI) studies has drastically decreased.
Purpose of the Study:
- To highlight the impact of the COVID-19 pandemic on cancer clinical trials.
- To propose necessary adaptations in oncology research methodologies.
- To ensure patient safety and maintain scientific integrity in clinical studies.
Main Methods:
- Review of clinical trial operations during the COVID-19 pandemic.
- Analysis of challenges faced by oncology researchers.
- Identification of adaptive strategies implemented by regulatory bodies and investigators.
Main Results:
- Significant decline in clinical trial accrual observed.
- Implementation of simplified treatment schedules and increased use of telemedicine.
- Reduced data collection requirements facilitated by regulatory adjustments.
Conclusions:
- The pandemic necessitates a redesign of oncology clinical trials.
- Future studies should prioritize patient safety, expanded access, and community physician partnerships.
- Adapting research protocols will accelerate clinical progress and protect vulnerable cancer patients.
Related Concept Videos
01:11Clinical Trials: Overview
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:28Preclinical Development: Overview
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
01:26Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...