Q & A with Don Berry
What motivated you to create Berry Consultants?
But my principal motivation for Berry Consultants (other than to work with Scott!) was to ensure that the early CDRH Bayesian experience was high in quality. I saw proposals for "Bayesian" medical device trials that were devoid of science. Their acceptance would have reflected very badly on the Bayesian approach and would have set it back decades. I worked to quash such non-science. Scott and I helped CDRH set high scientific standards in encouraging the Bayesian perspective--including by designing archetypical trials.
Could you briefly describe the history of Berry Consultants and its relations with the Industry?
Our history has one aspect that may not come through enough: CDRH. A primary impetus for Berry Consultants was CDRH's "Bayesian initiative," which began in 1997 in response to Congress's least burdensome mandate (In 1997 CDRH commissioned me to write a white paper outlining how the Bayesian approach could and should be used in medical device development to address this mandate.) The early growth of Berry Consultants paralleled the increasing acceptability of the Bayesian approach by medical device companies as well as regulators. Indeed, Berry Consultants was involved in most of the early Bayesian PMAs and IDEs. (At the public discussion of their draft Bayesian Guidance in July 2006, Larry Kessler introduced me as having had the most influence on CDRH's Bayesian initiative of anyone outside the FDA.)
How has the Industry attitute towards Bayesian Methodology evolved over recent years?
Over the last five years or so the benefits of taking a Bayesian perspective in pharmaceutical development have become clear to industry, especially its suitability for building adaptive clinical trial designs. A stumbling block was the dearth of quality Bayesian biostatisticians. Berry Consultants was ideally situated to fill the need, both in teaching and consulting. For example, in 2005 and 2006 I averaged about one presentation per week on using the Bayesian approach in drug development. During this period we continued to design trials for medical device companies and we designed adaptive Bayesian trials for most of the major pharmaceutical companies and for many small biotech companies as well. With success building on success, Berry Consultants was able to hire and train top young statisticians who could continue the tradition and improve upon it.