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Compliance In Focus
Posted by Stephani Hulec on Mon, Sep 21, 2020

The Latest On Remote Monitoring of Clinical Trials

Recent developments in remote clinical trial monitoring indicate it might soon become part of the standard process for researchers.

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Some of these developments have been visible to industry observers for the past decade. Others have been brought about by the global coronavirus pandemic.

Here’s an update on the state of remote monitoring of clinical trials.

The Rise Of Remote Monitoring

Federal regulators in the United States and international regulatory authorities have been encouraging remote monitoring of clinical trials since 2011, when the FDA published Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.

This guidance document aimed to help sponsors of clinical investigations develop risk-based monitoring strategies and plans for investigational studies of medical products, including drugs and medical devices.

The overarching goal of risk-based monitoring was to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. It prompted clinical trial sponsors to tailor their monitoring plans to the specific needs of their studies. This included using remote monitoring.

Two international organizations that regulate clinical trials have also accepted and encouraged the use of remote monitoring within their guidelines. These organizations are the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Organization for Standardization (ISO).

The State of Remote Monitoring Today

Remote monitoring of clinical trials has become increasingly popular in recent years for several reasons.

First, the number of clinical trials being conducted each year is growing, and clinical trials are becoming more complex.

Then there has been the introduction of new technologies (such as Adobe Sign and Citrix ShareFile), that enable remote monitoring while having the capability to meet the compliance standards of 21 CFR Part 11, the regulation that governs the scope and application of electronic records and electronic signatures and e-consent.

Finally, new software applications, developed specifically to facilitate clinical research, are offering safe, secure, remote access to electronic medical records. These software tools include electronic Trial Master Files (eTMFs) and Institutional Review Board (IRB) portals.

The global coronavirus pandemic, of course, forced sponsors and CROs to consider additional methods to complete monitoring activities because of the widespread lockdowns that prohibited on-site visits.

The Long-Term Benefits Of Remote Monitoring

Although remote monitoring of clinical trials has seen an increase because of the pandemic, industry analysts expect remote monitoring to continue long after investigators have returned to the office. There are several potential benefits to incorporating remote monitoring into study plans long-term, such as reduced cost, increased frequency of monitoring and more real-time review of patient data.

 

The FDA’s Latest Guidance On Remote Clinical Activities

In March, the FDA issued its FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. These updated guidelines for remote monitoring activities address the reality of conducting clinical trials during a time when researchers must weigh the benefits of in-person visits against the risk of potential exposure to COVID-19.

The FDA guidance for conducting clinical trials during COVID-19 restrictions supports remote monitoring for oversight of clinical sites. Risk-based decisions must be made on what data are critical to monitor, while ensuring subject safety, data quality and data integrity.

We covered the key points of the guidance and answered the most common concerns and questions. Here are the highlights:

  1. The first priority is the safety of trial participants.
  2. Consider options for remote patient assessments and alternative delivery of investigational product, when appropriate.
  3. Certain performance outcome assessments (PerfO) and interview-based clinician reported outcome (ClinRO) assessments may be feasible remotely.
  4. Sponsors should:
    • Consider if the remote technology is appropriate for the type of clinical data capture
    • Consider the need to compare in-person and remote assessments if only some outcome assessments will be captured remotely
    • Adequately prepare investigators
    • Develop procedures for participant technical support
    • Consider ways to ensure monitoring activities can be continued remotely, when feasible
 Contact FDA Review Divisions for specific questions about clinical trials when related to efficacy endpoints, changes in statistical analysis plans, or other key aspects of the trial. 

Monitoring Services Consult - V2

Key Considerations for Initiating Clinical Trials

Sponsors, in consultation with clinical investigators, Institutional Review Boards or Institutional Ethics Committees (and Data Monitoring Committees, if needed), should assess:

  • Whether COVID-19-related limitations on protocol implementation pose new safety risks to participants, and whether those risks can be mitigated by amending study processes/procedures (by enabling remote patient assessments, for example)
  • If investigators and sub-investigators are available to oversee a trial and monitor safety risks

Key Considerations For Continuing Clinical Trials

  • Consider using technologies to facilitate remote data collection and monitoring

Consider modifying protocols to eliminate apparent immediate hazards to participants before gaining IRB/FDA approval (reporting required afterward)

How IMARC Helps You With Remote Monitoring

You want to keep your trial on track, but physical distancing and travel restrictions make that difficult. Fortunately, IMARC has experience providing remote services, including:

  • Remote clinical research monitoring
  • Electronic Trial Master File audits
  • Remote training to keep your team sharp
  • Remote review of SOPs

As a global medical device CRO, IMARC believes monitoring means having eyes everywhere. We can assist with remote monitoring and data entry using secure, encrypted file-sharing technology. Our experienced monitors have a strong working knowledge of clinical research regulations and best practices. Learn more about our remote monitoring services.

Topics: Clinical Monitoring

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