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Compliance In Focus
Posted by Kelly Schindelholz on Tue, Aug 4, 2020

Are These 9 Clinical Monitoring Obstacles Derailing Your Study?

Clinical monitoring is challenging enough when everything goes as planned.

clinical-monitoring-challenges

Monitors are expected to review large volumes of study data and ensure your trial complies with all applicable FDA and ISO regulations, Institutional Review Board requirements and study protocol.

They are responsible for identifying compliance issues or inconsistencies before they lead to bigger problems that can cause delays or compromise data integrity.

When a monitor leaves or lacks proper training, it can impact your entire clinical trial. Here are nine common clinical monitoring obstacles you might encounter.

9 Common Clinical Monitoring Obstacles

1. High Turnover

High turnover is common among clinical research monitors. A recent BDO report cited by CenterWatch found that nearly 30% of monitors at contract research organizations (CROs) left their jobs in 2018.

The report cited stagnant salaries, a lack of upward mobility and extensive travel as the biggest factors influencing clinical monitoring turnover.

2. Monitoring Inconsistencies

Many monitors work in other areas of science or healthcare before becoming interested in clinical research and receive on-the-job training As a result, they may lack core competencies or basic knowledge of FDA regulations. There are a few formal clinical monitoring training programs, but they aren’t required. The Code of Federal Regulations (specifically 21 CFR 812.43) states that sponsors should select monitors who are qualified by training and experience, but it doesn’t elaborate on what that means.

This can lead to inconsistencies among monitors with different backgrounds and different levels of training.

3. Noncompliance

Monitors who don’t have a fundamental understanding of FDA regulations or study protocol can make missteps that lead to a lack of compliance within your study. Our review of the most recent round of FDA warning letters found one of the two most commonly cited violations involved a failure to follow the investigational plan. That includes making sure study subjects met all inclusion and exclusion criteria before enrollment.

As more sites adopt virtual activities to keep their clinical trials moving forward, ensuring the sites follow the protocol, including the informed consent process and electronic informed consent, eligibility, procedure and follow-up requirements, and facilitating monitoring visits will be even more critical. 

4. An Insufficient Clinical Monitoring Plan

Without a clear plan to follow, monitors don’t always know what to look for as they review study data. They may focus on the wrong things instead of what is most important.

This is why it’s so important to consider the frequency and extent of monitoring your study needs before you get started. If your study is testing a low-risk device for healthy individuals, you may not need the same level of monitoring as a Class III device being tested on a more vulnerable population. A risk-based monitoring plan gives your monitors clarity while making the best use of your resources.

Risk Based Monitoring Checklist

5. A Lack of Critical Thinking

Should patients who test positive for COVID-19 be excluded from your clinical trial? What if you discover a patient who initially met the enrollment criteria no longer does as the study continues?

Sometimes the answer isn’t always obvious.

That’s why it’s so important for monitors to be able to think critically, in addition to having a foundational knowledge of the regulations.

Our FAIR Shake™ method is designed to guide everyone involved in your study through these decisions, based on four criteria:

  • Federal regulations
  • Agreements with the sponsor
  • Investigational plan
  • Requirements of the Institutional Review Board (IRB)

Monitors who complete this training have told us it gave them more confidence to choose the right course of action when faced with uncertainty.

6. Out-of-Control Budgets

To help their internal staff manage their workloads, sponsors often enlist clinical monitoring support from a CRO. While this can be extremely beneficial, it’s important to account for the associated costs in your trial budget. Make sure you consider any hidden costs as you budget for a CRO. For instance, some CROs charge by the hour while others charge a monthly retainer or work on a per-project basis. You may also need to account for travel costs and costs associated with modifying the study protocol midway through the study.

7. Lack of Communication

In any clinical study, good communication is critical. Monitors must be able to communicate well with all parties, including the sponsor, principal investigator, research coordinators and any vendors involved.

It’s easy for things to get lost in translation or in someone’s cluttered inbox—which is why it’s important for everyone to use a consistent process for communicating updates.

8. Poor Data Quality

The ultimate goal for every clinical study is product approval—and that can only happen if your study data is correct, compliant and complete. As the old saying goes, if it wasn’t documented, it wasn’t done. Monitors should follow standard guidelines for reporting and reviewing data, such as the ALCOA-C checklist.

9. Monitors Who Are Overworked And Overwhelmed

Balancing travel, multiple studies and sites can be challenging. 

At the beginning of a study, it can be hard to predict when the busiest times will be.  Sometimes it can all happen at the same time.  It’s also true that at times, monitors can take on much more than what’s included in their job descriptions. This combination of travel, tight deadlines, and workload can often leave monitors feeling overwhelmed. When they become bogged down with multiple site visits, reports, and site management, they could be more likely to make mistakes.  When this happens, it can help to have an extra pair of hands to assist with on-site activities/making visits, site management, and general communication. 

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Don’t Get Frustrated; Get Help With Clinical Monitoring

If these monitoring obstacles sound all too familiar, it’s time to think about calling in some reinforcements. Our founder, Sandra Maddock, recognized the importance of consistent, quality monitoring when she founded IMARC Research two decades ago, and monitoring has been our core service offering since then.

Our monitors come from a variety of backgrounds and have a wide range of therapeutic expertise, including cardiology, orthopedics, wound care, women’s health and other areas. They all receive extensive training in clinical research regulations and how to apply them, along with real-world experience.

We can support your team with clinical monitoring services at any stage of your trial, from site initiation visits to on-site and remote monitoring, as well as study closeout.

The next time you encounter one of these challenges, don’t get discouraged. Take a deep breath and give us a call!

 

Topics: Clinical Monitoring

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