Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for some positions, take a close look at people who have thrived in different industries and jobs – they are usually more versatile, have transferable skills, and can potentially tackle problems creatively.”
He goes on to write: “Obviously a healthy mix of experience and novel thinking is the ideal, but on balance I would anticipate more fresh and objective solutions to flow from the smart and curious inexpert outsider than the ‘been there done that’ experts.”
Although the versatility to which Branson alludes is instrumental for successful statistical consulting, it is also obvious that an inexpert outsider would not be able to waltz into the drug development industry and make successful contributions. The expertise that is required is simply too much for a non-specialist. This raises an important question:
How should we, as an industry, walk this fine line between specialized expertise and versatile capabilities?
Consider, for example, the list of seven questions provided below.
These are typical questions which our customers often ask our statistical consultants. You will notice that the range of questions requires our consultants to draw upon multiple specialties: biostatistics, finance, regulatory awareness and so forth. Moreover, the answers often vary based on the size of our client, the financial and temporal constraints under which they are operating, and their further objectives (e.g. to sell a product to investors after Phase 2 or to carry the therapeutic into Phase 3.)
How do we develop the versatility necessary to cultivate statistical consultants who can answer all of these questions?
I have heard that adaptive trials can be very helpful. I have also heard that they are risky and difficult. How do I tell if one is right for my drug?
I try to stage investment in my company to maximize value for the founders. How do I stage clinical development to maximize the value of my asset for the second round of investment?
The drug we are working on is very expensive. What can I do to minimize drug cost in my clinical trials?
We are in a race with another company to get to an NDA. Can I get assurance that my trial will be completed on schedule?
Scheduling our DMC meetings and the quality of presentations from CROs are both nightmares, and they have a very negative effect on the quality of the decisions. What can I do about this?
We are thinking of running a trial to establish a biomarker, but there are some in my organization who say it won't help. How do I know who is right?
We need to defend our complex design in front of the FDA in three months. Our statisticians say we need computational algorithms to do the job. Where can I get that kind of help – statisticians who are adept at computer programming?
Theoretical, Technical & Practical Wisdom:
We might characterize the problem as the classical one of how to acquire practical wisdom as opposed to theoretical wisdom or technical wisdom within a particular field. While theory supposedly supplies the conceptual framework and guiding principles for application, technical expertise requires an understanding of the tools necessary for careful implementation. Practical wisdom, so the story goes, is neither theoretical nor technical. Rather, it makes use of both theory and technique, and adds the capacity to form judgments regarding what to do within a given (sometimes unfamiliar) situation.
It's that negotation between high level concepts and day-to-day applications that makes strategy exciting for a lot of consultants. Developing the capacity for such judgment formation requires, amongst other things, having the chances to exercise it – hence, the need for experience. However, as each situation is a little bit different, a little bit unlike anything that has come before, creativity and innovation are also instrumental for its success.
Moreover, this is difficult to do without ensuring that each consultant has developed multiple specialties, rather than simply one or two. Cytel's co-founder and Chief Technology Officer, Nitin Patel, once observed that we as a company needed a particular overlap of biostatisticians, management scientists and computer programmers to develop our earliest products.More than simply adding to existing capacities, this interdisciplinary work allowed imaginative solutions not provided by any one field. (To find out how this occurred, read A Horizon for the Stars.)
Another of our consultants, Senior Director of Consulting, Zoran Antonijevic, recently brought together a group of "multi-dimensional" specialists to write the first authoritative text on portfolio managemant and optimization in clinical development strategy. While the book provides a presentation of numerous innovative ways to leverage adaptive designs for finance, these innovations would not have been possible without the versatile, multi-dimensional specialist.
Unsurprisingly, the main spirit of Branson's vision remains true even within drug development. There are significant benefits to statistical consultants who have thrived in different fields, if not in different industries. Its the particular path that appears to need a bit of adaptation, perhaps innovation, for our industry.