New Clinical Trials Service Based on the Bayesian Method

Cambridge Consultants, a technology product design and development company, has announced it is to offer a new consultancy service for medical device clinical trials that will save clients time and money through a more effective method of analysing trial data. This news follows the announcement of the US Food and Drug Administration’s (FDA) finalised guidance, which allows the use of Bayesian statistical analysis in these trials. The guidance makes it possible to combine data collected in previous studies with data collected in a current trial. By combining this data, researchers can justify running shorter or smaller clinical trials that ultimately deliver cost savings to the sponsors of the trial.

The new consultancy service is expected to benefit medical device companies that are seeking to quickly comply with the new guidelines, but do not have the in-house experience of designing and analysing a Bayesian trial. The service includes clinical trial planning and design, analysis of historical data, trial simulation, software development and verification. Support on negotiating with the FDA is also part of the new service, with advice offered on trial planning, developing submissions and creating responses to regulatory questions.

The FDA issued its guidance on the use of Bayesian statistics in clinical trials in February 2010. It enabled companies to take full advantage of the statistical method. “The finalised guidance from the FDA has the potential to open the door to a wide ranging streamlining and improvement in clinical trials for medical devices,” commented Paula Gomes of Cambridge Consultants’ Global Medical Technology Practice. “With the wealth of experience Cambridge Consultants has in employing Bayesian methods we can help companies extract the maximum benefit from the technique and deliver smaller, shorter and more cost-effective clinical trials.”

Tags: Bayesian statistical analysis, Cambridge Consultants, Food and Drug Administration guidance