The yin and yang of drug development

From by Alexas_Fotos

Drug development teams are functional or cross-functional; local, regional or global; integrated or virtual. They have different goals, challenges, and team dynamics. For all their differences, two common guiding principles drive development programs.

The first is cautious optimism. It is the hope that outcomes will be positive, with a readiness for difficulties, or even failure. Optimism keeps teams motivated. A cautious approach acts as a counterbalance against persisting in the face of contrary evidence.

The second is informed skepticism. This is neither pessimism nor strict empiricism ( blind reliance on data). It involves evaluating assumptions and results and balancing analysis with judgment without getting swayed by baseline biases.

On development teams, clinicians personify cautious optimism. Doctors, by their purpose and training, must be optimistic about their ability to help. They treat patients knowing that some of them will lose their battles no matter what. Medical practice is often about taking chances, yet knowing when to stop treating and admitting that enough has been done. This outlook carries over to development, where clinicians articulate the medical need and risk-benefit of molecules as they progress or fail. Decisions must be guided by cautious optimism as progress is arduous, two steps forward and one step back.

The informed skeptics on the team are often the statisticians. We have “null” and “alternate”, not “negative” and “positive” hypotheses. We advocate looking at the data and other evidence and assessing where we stand. Statisticians recognize that inferences flow from assumptions (intuition, historical), models/methods (imperfect, simplistic), and the observed data (incomplete, confounded). We are careful in our conclusions, only because we know the limitations of what we have.

These two instincts can precipitate conflicts in teams. When all voices are heard, these are constructive and lead to thoughtful decisions. When individuals and teams can assimilate both cautious optimism and informed skepticism, they are no longer defined just by their roles; they become trialists and drug developers.

Originally published at on August 15, 2016.