Applied Clinical Trials
Five months have flashed past since the CBI's risk-based monitoring event, and so I was looking forward to observing how much the industry has moved on.
Five months have flashed past since the CBI's Risk-based Monitoring event, and so I was looking forward to observing how much the industry has moved on. At March's Clintech event in Boston, a dedicated RBM work stream gave me the opportunity to find out. In my last posting I cited 2014 as a year of learning and development, and it is shaping up to be exactly that. We are now seeing companies starting to define how they are going to approach the challenges and opportunities RBM presents.
Having spoken to most of the sponsor and CRO companies at the event I observed that two strong trends are emerging—those companies who are defining their philosophy / approach to RBM and those who are starting with the technology route. So this raises the age old question—should approach inform technology, or technology inform approach?
My advice is definitely to focus on approach first. The reason for this is simple. If you are going to use data to inform decision making, the model you use must support your organization's belief system. If it doesn't, the organization won't act upon the data, because its beliefs will say otherwise.
Think of the fuel gauge in your car—you are at liberty to accept that as an indicator of whether you are about to run out of fuel or not, but if you don't accept it, you better decide upon a different way of measuring the fuel level yourself. Either approach is fine, but what is not fine, is to agree that you'll go by what the fuel gauge tells you, and then ignore it when it goes into the red. It is just the same with risk indicators—agree how you want to measure risk, and then be sure to act. Once you know how you want to measure risk, and how you will act when a risk is identified, you can select the most appropriate technology to support that model.
How are you approaching the RBM journey? I’d love to hear from you and share some experiences.
Duncan Hall can be contacted at [email protected]