Have You Asked the Regulators?

To quote W Edwards Deming, “Every system is perfectly designed to give you exactly what you are getting today.” We all know our industry needs radical innovation and we are seeing it in many places – as you can see when attending DIA. I wonder why innovation seems to be so slow in our industry compared with others though.

I was talking to a systems vendor recently about changing the approach to QC for documents going in to the TMF. I was taken aback by the comment “Have you asked the regulators about it? I’m not sure what they would think.” Regulation understandably plays a big part in our industry but have we learned to fear it? If every time someone wants to try something new, the first response is “But what would the regulators think?” doesn’t that limit innovation and improvement? I’m not arguing for ignoring regulation, of course, it is there for a very important purpose. But does our attitude to it stifle innovation?

When you consider the update to ICH E6 (R2), it is not exactly radical when compared with other industries. Carrying out a formal risk assessment has been standard for Health & Safety in factories and workplaces for years. ISO – not a body known for moving swiftly – introduced its risk management standard ISO 13000 in 2009. The financial sector started developing their approach to risk management in the 1980s (although that didn’t seem to stop the 2008 financial crash!) And, of course, insurance has been based on understanding and quantifying risk for decades before that.

There has always been a level of risk management in clinical trials – but usually rather informal and based on the knowledge and experience of the individuals involved in running the trial. Implementing ICH E6 (R2) brings a more formal approach and encourages lessons learned to be used as part of risk assessment, evaluation and control for other trials.

So, if ICH E6 (R2) is not radical, why did our industry not have a formal and developed approach to risk management beforehand? Could it be this fear of the regulator? Do we have to wait until the regulators tell us it is OK to think the unthinkable (such as not having 100% SDV)?

What do you think? Is our pace of change right? Does fear of regulators limit our horizons?