As the CEO of a CRO, I’m frequently asked about the role of risk in outsourced drug development. There’s no definite answer to this, but as we develop strong, long-term relationships with our partners, I suggest there are three ways of looking at this issue.
First, every sponsor faces the risk of launching a drug with inadequate research findings and potential adverse affects for patients. While much of this risk cannot be mitigated, we firmly believe agile design – combined with some of the most advanced informatic diagnostics – can greatly reduce the risk of unseen events. This ultimately leads to safe products with proven efficacy for patients in need.
Second, sponsors face risk associated with the financial and corporate ramifications of trial failure. When a study fails, the company has allocated capital and resources that – in hindsight – could have been more effectively used elsewhere. Mitigating that risk through quicker and better informed decision making is possible in today’s informatic-based research.
Last – but certainly not least – is the level of personal risk. In an environment of constant mergers and acquisitions, outsourcing, and head count reduction, many employees are hesitant to face the risk of personal failure. Business decisions can sometimes be driven by this very personal risk. A fully integrated CRO partner – with real risk-sharing (or as they say “skin-in-the-game”) can alleviate that risk and make it possible for decisions to be made in the best business context.
Increasingly, we see sponsors seeking innovative – and effective – ways to achieve mitigation at all three levels. It isn’t easy, but it CAN be done. As the industry continues to evolve these solutions will become commonplace. In future blogs, I will look at some of these innovations – including specific examples at each of the aforementioned levels.
Until then, it would be great to hear about your thoughts on risk – including how your company is looking at it and more importantly what they are doing about it.