The topic of remote monitoring of clinical trials has gotten enormous attention since February of this year, as travel to clinical sites became difficult and, in some cases, impossible. Whether at conferences (virtual, of course) or on-line, ClinOps leaders are urgently researching their options and how to navigate the path to a remote monitoring model.
We’ve done our fair share of research into remote monitoring and we want to help you with yours. Here are five resources we found useful. Each item includes a summary of what it contains and how it fits into the overall topic.
1. A (Very) Brief Primer on Monitoring
“Clinical Trial Monitoring,” Clinical Health Trials, February 2, 2010, Editorial Team
This short article defines and summarizes the monitoring function; We have included it here mostly because it has some useful links to standard monitoring tools in the form of templates for things like SOPs, guidelines, checklists, and documents for monitoring.
Study Note: Use this as an introduction for team members on the monitoring function or if you are looking for some free templates.
The Takeaway: The monitoring function and role are part of clinical trial oversight, and they include specific processes.
2. A Foundation Document: The Baseline Regulatory Perspective
“Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring,” U.S. Department of Health and Human Services, August 2013
This FDA document provides the initial, formal guidance on risk-based monitoring, which clearly signaled that the FDA did not require 100% source data verification for all trials. It signaled a more pragmatic perspective from the FDA on what is required, including quality and monitoring activities. Importantly and specifically, it also introduces and discusses centralized and on-site monitoring and what needs to be done in terms of the monitoring process and monitoring plan when making decisions about using different approaches.
Additional guidance documents provide Covid-specific updates to the regulatory guidance on remote monitoring:
- FDA guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (last updated April 2, 2020)
- EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (March 27, 2020)
- EMA guidance on Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (March 25, 2020)
- MHRA guidance on Managing Clinical Trials During Coronavirus (COVID-19) (Last updated March 24, 2020
- UK NHS Guidance about COVID-19 for sponsors, sites, and researchers (Last updated on April 6, 2020)
Study Note: If you can only spend five minutes, read starting on page 7, the section on “Example of Alternative Monitoring techniques.”
The Takeaway: The FDA has supported alternative monitoring models, including remote monitoring, for a long time, as long as they are planned and documented correctly and include a risk assessment.
3. Quick Read on Remote Monitoring Benefits
“COVID-19 Creates Urgent Need for Remote Monitoring in Clinical Trials”, Clinical Researcher—May 2020 (Volume 34, Issue 5), Jason Methia, MS
This short article describes four key ways that remote monitoring improves study performance: Better data quality, increased speed, lower costs, and increased efficiency. It is not a data-filled nor rigorous article, but it can help build the case for a shift to remote monitoring.
Study Note: If you just need some points for an internal case for remote monitoring, borrow the charts and section headers and reference the source, a respected journal.
The Takeaway: Remote monitoring is not a compromise; it is a better process for executing the monitoring function versus an entirely on-site model.
4. A Starter Guide for Remote Monitoring
“Remote Clinical Trial Monitoring in the time of COVID-19: Working Safer and Smarter”, Conference Presentation, July 29, 2020, Shirin R. Hasan
Beware, this is a vendor presentation! Nonetheless, this conference presentation by Shirin Hasan acts as a good transition from thinking about remote monitoring to getting started. Keep it handy for the slides that layout the differences between monitoring approaches, the benefits, and the challenges. And pay attention to the recommendations on how to transition successfully.
Study Note: Unless you need a primer on monitoring, skip to the slides in the middle of the presentation, especially those in the “Switching to Remote Monitoring” section and the “Best Practices” section.
The Takeaway: There is a proven path for making the switch to remote monitoring, and there are clear best practices. Among the most important are documenting the planned approach in detail, training the participants carefully, and having a contingency plan to fall back on.
5. A Q&A about Remote Monitoring and Covid
“Adjusting To Clinical Trial Remote Monitoring During COVID-19: Working Smarter & Safer”, Clinical Leader, April 10, 2020, Todd Johnson and Hannah Yee
This is the article to read if you are moving into the planning phase of a move to remote monitoring. The authors (two consultants) lay out a step-by-step model for the transition, from initial analysis through training and implementation within a study. It is easy to read and worth the time.
Study Note: Scan the questions that act as the section headers. Watch for questions that align with your own, and skip the parts that do not apply to you.
The Takeaway: There is a clear set of steps to work through to transition to remote monitoring, and Covid is a clear driver. It is not particularly complicated, but you need to work through a set of decisions and document your plan.
Additional Information Sources from Agatha
Agatha has been actively researching the evolution, adoption, and remote monitoring technologies since early 2020 and published several blogs and white papers on the topics. As a technology vendor, we are particularly focused on the development and successful adoption of technology tools for remote monitoring. Here are some of the materials you may find useful; You can find them all on the Agatha Website Resources Page.
Remote Monitoring & Quality Management: A Technology Guide. In this technology guide, we look at the role of remote monitoring in clinical trials, the activities performed, and the key capabilities you need in a technology solution. Click here to read this whitepaper.
Five Keys to Success: Remote Monitoring & Quality Management. From our work with a number of sponsors, CRO, and site organizations, we documented five key things you need to do at the site level to ensure success when transitioning to remote monitoring and Clinical Trial Management.
The State of Remote Monitoring: Survey Results. In the summer of 2020, Agatha surveyed sponsors, CROs, and clinical sites to understand where they stand today in their use of remote processes technologies and their plans going forward. In this report, we cover our survey results and provide insights and guidance into the state of remote monitoring and quality processes in clinical trials.
Or You Can Try Agatha. Agatha offers a free pilot of our Remote Monitoring Application to any organization. Click here if you want to take advantage of our “Try Agatha” offer. You will get hands-on experience with Agatha Remote ISF enabling you to evaluate how it can be incorporated into your business.
Looking for More Resources?
If you’re like us, you can never have enough information on remote monitoring for clinical trials. Good news! We have more. You can download our full resource list with ten great resources (that’s five more than what you’ve read here). Get your remote monitoring research guide and get ready to start reading! And if you want to talk remote monitoring with our team, you can contact us anytime.