Decentralized trial tools and technologies are here to stay: A regulatory perspective
Decentralized clinical trial (DCT) strategies and tools such as telehealth visits, centralized monitoring, and remote source data verification (SDV) gained traction overnight during the Coronavirus Disease (COVID-19) pandemic, while already common practices such as direct-to-patient (DTP) drug delivery and home nursing became even more widespread.
Regulators rapidly adjusted the rules on protocol deviations in unprecedented ways to ensure the continuation of clinical research. For example, when the World Health Organization (WHO) declared COVID-19 a global pandemic in March 2020, both the FDA and EMA issued guidance on conducting clinical trials (CTs) that allowed the substitution of remote approaches for on-site activities. In all, dozens of health authorities (HAs) around the world published pandemic rules.
As some countries slowly start to bring the pandemic under control, many companies are wondering whether clinical research will revert to the old ways? The short answer is no.
Related Insights
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Article
Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct
Sep 14, 2021
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Article
How a joined-up development strategy pays off for early-stage biotechs
May 19, 2021
Video
Part 2: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Related Insights
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Article
Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct
Sep 14, 2021
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Article
How a joined-up development strategy pays off for early-stage biotechs
May 19, 2021
Video
Part 2: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023