US FDA says Bayesian analysis could cut device trial costs

By Staff Reporter

- Last updated on GMT

Related tags: Scientific method

The US Food and Drug Administration (FDA) has issued guidance on the use of Bayesian analysis in clinical trials of medical devices and says the technique can cut costs and boost efficiency.

Commonly used frequency-based statistical methods only allow data from previous studies to be factored into new trials at the design stage, rather than the analysis stage where information is considered an adjunct to, not part of, new results.

In contrast, the Bayesian approach being advocated by the FDA view data from both old and new studies as a continuous stream of information, enabling available information to be considered during results analysis.

The FDA believes that: “When good prior information on clinical use of a device exists, the Bayesian approach may enable this information to be incorporated into the statistical analysis of a trial. In some circumstances, the prior information for a device may be a justification for a smaller-sized or shorter-duration pivotal trial​.”

According to the agency Bayesian analysis is particularly suited to medical devices because, unlike pharmaceuticals, their effects are usually physical and therefore limited to specific areas rather than systemic.

It added that: “As a result, device effects are typically local, not systemic. Local effects can sometimes be predictable from prior information on the previous generations of a device when modifications to the device are minor.

The FDA went on to says that Bayesian methods can also be used to include information from medical device trials conducted overseas, which would be more problematic with drugs.

In a statement accompanying the launch, FDA commissioner Margaret Hamburg said the new guidelines are consistent with the agency’s “commitment to streamline clinical trials, when possible, in order to get safe and effective products to the market faster​.”

While the FDA's support for Bayesian analysis is patient focused, the new guidance focus on cost reduction means will surely be welcomed by medical device developers and the increasing number of contract research organisations (CROs) offering biostatistics services.

The guidance document can be found here​.

Related news

Show more

Related products

show more

The APAC Advantages

The APAC Advantages

Catalent Pharma Solutions | 18-Jan-2022 | Insight Guide

Over recent years, the Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies.

CellCarta - Mapping Precision Medicine

CellCarta - Mapping Precision Medicine

CellCarta | 17-Jan-2022 | Product Presentation

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

Planning Your Preclinical Assessment

Planning Your Preclinical Assessment

Altasciences | 17-Jan-2022 | Technical / White Paper

There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful...

How a Clinical MDR Helps with Data Quality

How a Clinical MDR Helps with Data Quality

Formedix | 17-Jan-2022 | Technical / White Paper

This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to...

Related suppliers

Follow us

Products

View more

Webinars