Tuesday, September 21, 2010

Future of clinical trials recap

Clinical trials are complex, so any meeting about the future of trials is going to be complex. Indeed, the  Future of Clinical Trials meeting had something from many perspectives from recruitment to ethics to statistics. Of course, I viewed most of the presentations with an eye for how to apply them to adaptive trials. So, here's the themes of what I heard in the presentations:

  • Relationships are going to be the most important key to the success of any clinical trial. Pharma companies are starting to outsource in such a way that they expect a strategic partner-level participation by the vendor (such as a clinical research organization-CRO), and the CRO had best bring its A-game regarding project management, design and execution of trials.
  • I had not thought about this particular area, but business development is going to play a key role as well. We discussed several aspects, but one that sticks in my mind is structuring contracts in such a way to minimize change orders. I think this will be helpful because change orders take precious time away from the team and make the relationship more difficult to maintain.
  • Regulatory uncertainty drives us to be more efficient, but we are also uncertain about the changes that are required to make us more efficient. We can expect the difficult regulatory environment to get worse before it gets better because of the recent politicization of drug safety.
  • I think a new wave of technologies is going to make designing and running trials more efficient. Improvements are being made to study startup, clinical trial management, patient recruitment, site selection, and ethics approval of protocols. It may take a while, but any company wanting to stay competitive will need to either employ some of these technologies or use something else to make up the lag in efficiency.
This is only a small overview. I think we will be hearing a lot more about these issues in the years to come.