Best Practices for Quality, Compliant Clinical Trials
It’s simple: Quality research is nonnegotiable. Stakeholders, your bottom line, and patients are relying on you conducting a compliant, safe trial that quickly and safely brings your product to market. However, regulations, FDA guidance, and other controls are complex. How can you successfully navigate these complexities to ensure all aspects of your trial are high quality, will withstand scrutiny, and protect the patient?
“Quality Research Essentials: Don’t Be the Next Cautionary Tale,” an Elligo Elite Learning Series presentation, is an open roundtable discussion on high-quality, compliant clinical trials. Featuring industry leaders Julieann Blasingim, VP of Compliance and Development at Elligo Health Research®; Debra Fontana, Consultant at Polaris Compliance Consultants, Inc.; and Linda McCarty, Chief Legal Officer and Privacy Officer of Javara, the webinar unfolds in six parts: FDA inspection trends, advice for reducing risk and increasing certainty in research, common findings from 2022 site and sponsor inspections, how to get ahead of quality assurance and risk mitigation, practical tips for ensuring compliance, and a Q&A.
FDA Inspection Trends
Though the COVID-19 pandemic brought a dip in FDA inspections, the industry is seeing an increase that is quickly reaching pre-pandemic levels. To begin the discussion, Julieann digs into how sponsors can use this increase in inspection trends for their benefit: namely, monitoring what the FDA is looking at during these inspections to increase preparedness and quality. She gives instructions for where and how to monitor inspection goals and results and finishes with a discussion of FDA inspection classifications and how many there’s been of each type in recent years.
How to Reduce Risk and Increase Certainty in Research
In this section of the webinar, Julieann details the 3 main tenets of a good quality assurance program:
- Culture of compliance
- Research team training
- Reducing human error or process failure
She also discusses practical tips for developing and maintaining a quality assurance program, providing details on day-to-day actions and process optimizations for each of these three areas.
Common Findings From 2022 Site and Sponsor Inspections
As inspections are ramping up, what are the most common findings? Debra goes through frequent findings from site and sponsor inspections in 2022. She lists several for sites, such as failure to follow the investigational plan and inadequate subject protection, as well as several for sponsors including failure to ensure proper monitoring of the study, failure to maintain and/or retain adequate records in accordance with 21CFR312.57, and failure to submit an Investigational New Drug (IND) safety report.
Debra also compares the 2022 findings with those from the past decade. Using the comparison to discern what might be contributing to these recurring findings, such as a lack of sponsor oversight of delegated duties, functions, tasks, or trial master file misconceptions, she offers ideas how sponsors can avoid these same findings in their own research.
How to Get Ahead of Quality Assurance and Risk Mitigation
Clinical research regulations are complex, so sponsors need a multipronged approach that spans all functional areas from operations and HR to technology, legal, and marketing. Linda jumps in to provide a legal perspective on such a multipronged approach. She also gives tips for getting a head start on quality and risk mitigation before a trial begins, such as how to assess feasibility and things to look out for when conducting a comprehensive legal and regulatory review of a trial.
Practical Tips for Ensuring Compliance
The webinar then shifts into a roundtable discussion in which all the panelists offer insights for ensuring compliance. They dig into concepts such as how to get leadership bought into a culture of compliance if one is not already established, how technology might hinder quality, and the pros and cons of remote and on-site audits. The panelists also consider if or when the FDA will shift its main areas of inspection focus, and how the agency’s recent guidance documents might be offering clues to its new focus areas.
Q&A
In the final portion of the webinar, the panelists answer viewer questions on topics like quality gaps because of technology variations and improving quality on a budget.
When You Want to Reduce Risk and Increase Certainty in Your Research, You Need Elligo
For further insights into how you can ensure all aspects of your trial are high quality, will withstand scrutiny, and protect the patient, watch the recording of “Quality Research Essentials: Don’t Be the Next Cautionary Tale.” You can also contact our team to explore our quality assurance solutions.