Innovative Trials
Clinical Trials Issues Related to COVID-19
Topics Included: Access to Clinical Trials, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals
SHARE TO:
Overview
The COVID-19 pandemic caused unprecedented disruptions to nearly every aspect of clinical research.
To help, CTTI led several efforts -- including conducting surveys, holding webinars, and developing resources -- with the goal of helping the clinical trials ecosystem adapt and move forward during the pandemic, including:
- Two playbooks of best practices: "Best Practices for Conducting Trials During the COVID-19 Pandemic" and "Best Practices for Designing High-Quality, Diverse COVID-19 Trials".
- Recordings of six CTTI COVID-19 webinars are available:
- Identifying Best Practices for Conducting Clinical Trials with FDA's COVID-19 Guidance
- Designing High-Quality, Streamlined COVID-19 Trials
- Solutions for Switching to Remote and Virtual Visits
- Engaging Racial and Ethnic Minority Patient Populations during the Pandemic
- Using Master Protocol Studies for Effective COVID-19 Treatments
- The State of U.S. COVID-19 Treatment Clinical Trials
- A daily searchable spreadsheet of the COVID-19-related studies posted on ClinicalTrials.gov is also available.
Resources
Innovative Trials | Recommendations
Digital Health Trials: Recommendations for Managing Data
Digital Health Trials: Recommendations for Managing Data
Regulatory Submissions + Approvals | Recommendations
Digital Health Trials: Recommendations for Interacting with Regulators
Digital Health Trials: Recommendations for Interacting with Regulators
Regulatory Submissions + Approvals
Clinical Trials Issues Related to COVID-19
The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.
Innovative Trials | Resources
Master Protocol Studies: Emerging Best Practices to Drive Multi-Stakeholder Collaboration & Mobilization
Master Protocol Studies: Emerging Best Practices to Drive Multi-Stakeholder Collaboration & Mobilization
Site Planning | Case Studies
Curebase Pioneers Completely Virtual Site to Meet Patients Where They Are
Curebase Pioneers Completely Virtual Site to Meet Patients Where They Are
Innovative Trials | Case Studies
NIH Funds Six Large Simple Trials to Rapidly Advance Answers
NIH Funds Six Large Simple Trials to Rapidly Advance Answers
Regulatory Submissions + Approvals | Resources
Flowchart: Steps For Novel Endpoint Development
Flowchart: Steps For Novel Endpoint Development
Regulatory Submissions + Approvals | Resources
Detailed Steps for Novel Endpoint Development with Suggested Approaches & Considerations
Detailed Steps for Novel Endpoint Development with Suggested Approaches & Considerations
Site Planning | Resources
Planning Trials Using Mobile Technologies: Gathering Patient & Site Input
Planning Trials Using Mobile Technologies: Gathering Patient & Site Input