Written by Lorraine Ellis, CEO and Founder of Research Dynamics, a Rochester, NY based contract research organization (CRO).
Although clinical research according to GCP requirements has been conducted for decades, there is still much variability in the conduct of research at sites and in the quality of monitoring by the Sponsors. How do we build and measure quality into our clinical trials? Let’s review some of the reasons for the poor quality and then discuss ways to build-in quality.
Site Quality Variability
As you know, sites vary from green sites to experienced sites and from a single Principal Investigator to Multi-Investigator sites. The quality also varies with the various parameters so, although there are trends, there appears to be no direct correlation between site size and quality. Although there is evidence that more experienced sites have better study quality, these sites can also receive poor results from a Sponsor audit or receive a FDA 483 from an FDA audit.
What are some of the key reasons for poor quality at Investigator sites?
- Inadequate staff training in GCP and protocol
- Poor or lack of PI supervision or quality control of task completion during the study
- Insufficient protocol understanding or protocol clarity
- Poor quality control over collection and recording of study data
Sponsor Monitoring Quality
Monitors have one of the toughest jobs in maintaining quality in clinical trials. Even the simplest of clinical trials have many areas of compliance to assess: protocol, GCP, data collection, study procedures, product accountability, etc. If there are areas of non-compliance at a site, the monitor must find it, report it and determine how to get the site back into compliance. Most monitors are effective at finding and reporting non-compliance. However, according to recent FDA warning letters, monitors and Sponsors are not as effective at designing and implementing Corrective Action Plans (CAP) to remedy the non-compliance and get the site back into compliance. In fact in some cases, according to some warning letters, some monitors are not able to find the non-compliance to report it which results in poor monitoring quality. Since it is a Sponsor responsibility to ensure a site is in compliance, the skill of getting a site back into compliance and improving site quality is critical.
What are some of the key reasons for poor monitoring quality?
- Lack of monitor training in GCP, protocol and monitoring techniques
- Poor oversight of monitors’ activities and reports
- Insufficient time for the monitors to conduct the visit
- Poor monitoring skills and expertise.
- Inadequate understanding of protocol requirements
So given these effects on the quality of clinical research from site and monitor activities, how do we prevent or mitigate them to assure clinical research quality?
There are 5 activities that will improve clinical trial quality (and compliance) in both site and monitor performance:
- Standard processes and procedures
- Effective training
- Clear roles and responsibilities
- Effective PI or management oversight and accountability
- Adequate study specific training (eg. protocol training)
Quality clinical trials occur when there is standardization (eg. SOPs, roles, etc.) and a verification (audit or oversight) to ensure that the standards are known (training) and being met. Standards provide consistent results and when the results are based on quality parameters, quality is the result.
To get started, you may want to have an audit of your site or monitoring activities to find the critical areas where you need to initiate actions to start building quality into your clinical trials. Then use the 5 activities listed above to improve your quality.
You’ll save time and costs too! It is more cost-effective to do it right the first time, then to do re-work and spend time fixing the error.
For more information, visit the Research Dynamics website.