This video lecture discusses the impact of COVID-19 on clinical trials, potential pathways and modifications needed to run a successful trial and how new technologies can assist in moving forward.
Clinical Trials During COVID-19
$49.00
- Session: year 2020
- Course Type: Video Lessons
- Language: English
- Level: Intermediate
- Time: 0 - 1 Hour
Topics
| Section | Time |
|---|---|
| INTRODUCTION | |
| Course introduction | 00:00:08 |
| Additional resources | 00:00:05 |
| Research Continuity During COVID-19 | 00:00:49 |
| Speakers | 00:00:41 |
| Impact On Clinical Trials | 00:00:25 |
| Major Disruption | 00:00:50 |
| EMA: Who They Are | 00:00:48 |
| EMA Regulatory Guidance | 00:01:18 |
| MHRA: Who They Are | 00:00:58 |
| MHRA Regulatory Guidance | 00:02:46 |
| FDA: Who They Are | 00:00:51 |
| FDA Regulatory Guidance | 00:01:52 |
| Regulatory guidance summarized – pt. 1 | 00:00:43 |
| Regulatory guidance summarized – pt. 2 | 00:00:35 |
| Trial Assessment | 00:00:39 |
| Tiered Approach | 00:00:31 |
| If continued enrollment or engagement is required | 00:01:00 |
| If the trial will be halted | 00:00:31 |
| In Any Scenario | 00:00:20 |
| Thinking in and outside the box – pt. 1 | 00:00:51 |
| Thinking in and outside the box – pt. 2 | 00:00:39 |
| Assessing tools and suppliers | 00:01:06 |
| How Meditrial Fits In | 00:01:20 |
| What meditrial is doing in the COVID-19 fight – pt. 1 | 00:00:59 |
| What meditrial is doing in the COVID-19 fight – pt. 2 | 00:01:18 |
Description
What I will learn?
In this course, we discuss the struggles of conducting a clinical trial during the COVID-19 pandemic, getting know the key guidance released by Competent Authorities.
Skills I will gain
- You will find out how to do a risk assessment of your trial, considering the participants safety
- You will gain insight on the regulatory guidance created by EMA, MHRA and FDA especially for trials during this pandemic
- You will learn how to use technology to your advantage (remote monitoring, enrollment, informed consent)
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