- Properly implementing advanced statistical methods can deliver shorter, smaller, more effective clinical trials for medical devices
Cambridge Consultants, a leading technology product design and development firm, has announced it is to offer a new consultancy service for medical device clinical trials, saving clients both time and money through a more effective method of analysing trial data. The news follows the announcement of the US Food and Drug Administration’s (FDA) finalised guidance, allowing the use of Bayesian statistical analysis in such trials. The new service is expected to benefit medical device companies looking to quickly comply with the new guidelines, but who do not have the in-house experience of designing and analysing a Bayesian trial.
Already offering companies a wide range of support services in adopting Bayesian methods, Cambridge Consultants new consultancy service is predicted to deliver significant benefits to patients, doctors, trial sponsors and regulators. The new support 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. Cambridge Consultants’ expertise is based on its long history of developing innovative medical devices and getting them to market quickly, as well as its own use of Bayesian statistical methods in its research and testing.
The FDA issued its guidance on the use of Bayesian statistics in clinical trials in February 2010, enabling companies to take full advantage of the statistical method. This method makes it possible for companies 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, ultimately delivering cost savings to the sponsors of the trial. Moreover, both patients and doctors can also benefit from the use of the statistical analysis. For doctors, shorter and more efficient trials mean that they can design trials to look at multiple potential treatment combinations simultaneously and refine the treatments to treat each patient optimally. As a result, the trial participants are more likely to receive effective treatment; shorter trials also mean that new treatments will reach patients, and the wider market, faster.
“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.”
Notes for editors:
Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology critical issues for clients worldwide. For 50 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of over 300 engineers, designers, scientists and consultants, in offices in Cambridge (UK) and Boston (USA), Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, transport, energy, cleantech and wireless communications.
Throughout 2010, Cambridge Consultants celebrates its 50th year in business. Created by three Cambridge graduates in 1960, the company has grown into a leading technology business, renowned worldwide for its ability to solve technical problems and provide innovative, practical solutions to commercial issues. In 2009, the company was awarded the prestigious Queen’s Award for Enterprise in International Trade. For more information visit: www.CambridgeConsultants.com
Cambridge Consultants is part of Altran, the European leader in innovation and high technology consulting. The Group’s 17,500 consultants, operating worldwide, cover the entire range of engineering specialities, including electronics, information technology, quality and organisation. Altran offers its clients ongoing support throughout the innovation cycle, from technology watch, applied basic research and management consulting to industrial systems engineering and information systems. The Group provides services to most industries, including the automotive, aeronautics, space, life sciences and telecommunications sectors. Founded in 1982, Altran operates in 20 priority countries. In 2008, it generated a turnover of €1,650 million. For more information visit: www.altran.com