MCRA Forms Partnership to Maximize Clinical Trial Effciency

But two companies have joined forces to simplify that process and determine the best clinical trial strategy for clients. Musculoskeletal Clincal Regulatory Advisors LLC (MCRA) recently announced its partnership with Biomedical Statistical Consulting (BSC), a Wynnewood, Pa.-based company that designs and implements regulatory clinical trials for orthopedic devices.

“Medical device regulations and pathways are constantly evolving,’’ noted Glenn Stiegman, vice president of regulatory affairs at MCRA. “MCRA’s clients require cost effective approaches to drive their technologies from conception to market as expeditiously as possible. We have previously worked with BSC on multiple PMA/IDE (pre-market approval/investigational device exemption) clinical trials and the combination of our skill sets will create efficiencies leading to best-in-class clinical trial execution.’’

Most clinical trials utilize the traditional statistical approach, otherwise known as frequentist. The frequentist philosophy is the cornerstone of classical mathematical statistics and hypothesis testing. Based on probability, it focuses on the relative frequency of the occurence of an event. Sometimes, however, a different approach is needed to increase the chances that a clinical trial will be successful. Such an approach is known as Bayesian and it involves collecting data from past events or experiences in order to reach a conclusion about future events. The Bayesian method has grown in popularity in recent years, though it can be controversial.

Officials at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a final Guidance on the use of Bayesian statistics in clinical trials in February. The Guidance states that Bayesian methods usually are less controversial when prior information is based on empirical evidence such as data from clinical trials. However, Bayesian methods can be controversial when the prior information is based mostly on personal opinion (often derived from “experts”).

The CDRH guidance document concluded that the Bayesian approach is not a substitute for sound science. “Scientifically sound clinical trial planning and rigorous trial conduct are important regardless of whether you use a Bayesian or frequentis approach,’’ the document read. “…remain vigilant regarding randomization, concurrent controls, prospective planning, blinding, bias, precision, and all other factors that go into a successful clinical trial.’’

BSC executives agree with the guidance document.

“A biostatistician’s toolbox should include frequentist, Bayesian and adaptive [clinical] design approaches,’’ said Greg Maislin, principal biostatistician at Biomedical Statistical Consulting. “BSC has specialized in applying statistical methodology in the orthopedics industry and our partnership with MCRA will enable us to bring solutions to the problems surrounding the clinical trial and U.S. regulatory processes.’’

The combined service offerings of MCRA and BSC include the strategy, development, and execution of regulatory submissions, as well as clinical trial set-up and implementation, in addition to quality assurance, reimbursement and compliance oversight, executives with both firms said.