We work together with the pharmaceutical industry to develop agents
to improve the lives of diabetic patients. It is in our joint
interest to identify promising areas for drug development and to streamline
the processes leading to approval and marketing of new agents.
As the lead investigators in numerous studies which have brought new drugs
into common use, we have acquired a unique experience in the
processes and pitfalls of drug development.
We understand the critical importance of cleanly designed protocols
which capture necessary critical information, without overwhelming
the system in extraneous details. We have seen protocols fail due
to mistakes in data collection. We have learned the essentials
of realistic patient selection criteria. We realize the errors which
occur when practical clinical details are overlooked. We have seen
the delays in patient enrollment which occur when criteria are too restrictive.
We understand the central role of data collection. We have seen
paper based systems give way to remote data entry and then return to paper
when computer systems became unmanageable. We have worked with
good systems and with bad systems.
We have seen the overwhelming importance of generating investigator
commitment. Investigators who believe in a study will overcome
any problems which arise and will become enthusiastic spokesmen for development
and later marketing of a new agent. We know that the goal of
drug development is more than simply obtaining approval. The key
to success is to ask the right questions during drug development so as
to determine the appropriate use of an agent once marketed.
We want to share our experience. Members of our group are
willing to consult in the early stages of drug development to help sponsors
streamline the process of evaluation and approval. Together,
we can provide input across the spectrum of the development, clinical trial
performance, approval, and marketing process.