May 9, 2017 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Lee Truax-Bellows, President & CEO of Norwich Clinical Research Associates Ltd. (NCRA)

Lee, what do you think it’s about time for the clinical research enterprise to start doing?

Norm, it’s about time we stop paying lip service to using a Quality Management System (QMS) approach and start practicing it. GCP guidance, both drug (E6(R2)) and device (ISO 14155:2011), address using comprehensive risk management, an important QMS component, so it’s time we get serious about a systems approach to quality.

What do you see as the benefits of QMS?

With a QMS, data quality is higher. Things are done right the first time, so the study just goes more smoothly, saving time and money. The study meets its milestones on schedule. Sponsor, CRO and site personnel, and even study participants are happier…and stick around. Quality isn’t just free…it pays.

Everyone says quality is number two, right after patient safety, so what's holding us back?

QMS requires a change in mind-set. You have to fight the temptation to go-go-go and worry about the details later. A lot of training is required, not just of sponsor and CRO personnel but also of site and vendor personnel. The shape of timelines and budgets needs to change. Expectations need to change. Metrics need to change. Everybody needs to understand that investing in quality pays.

What's been done so far?

There are a lot of training and certification programs to help clinical research professionals gain the skills and knowledge to do quality work. The Clinical Trials Transformation Initiative (CTTI) has initiated training standards and is working on other QMS concepts, e.g., quality by design (QbD). The Joint Task Force on Clinical Trial Competency is taking a systems-based approach to defining training needs. Moving from paper-based to electronic systems helps build quality into the system. Risk-based monitoring is an important element of QMS. Many leading investigative sites have discovered that quality pays, provided you can enroll the patients.

Lee, you make a strong case. Let's hope the clinical research enterprise buys it.