CRO Health Decisions offers to share risks on adaptive trials

After honing its skills running adaptive clinical trials, Durham, NC-based CRO Health Decisions is moving to a risk-sharing trial model. And it's inked a deal to manage a sizable Phase III study under this "fixed price" approach, through which it can earn a slice of product sales for each month it shaves off the trial schedule. If the CRO falls behind schedule or runs over budget, those setbacks will eat into its revenue.

The CRO reports it has set up a new division to handle the development of more of these risk sharing deals. For the CRO, it's all about responding to a central question in drug development: How do you conduct faster, more efficient clinical trials when drug development costs are getting higher and higher?

The answer, says Health Decisions CEO Michael Rosenberg, has been to do a better job with new adaptive techniques in the clinic--such as an ongoing evaluation of dosages--as well as the operational aspects of a study. For example, patient enrollment in a study frequently careens off schedule, but an adaptive approach using daily evaluations of results at sites worldwide allow you to fix anything going wrong before it pushes you off schedule. Do it right, he adds, and you can trim the amount of time needed for a study, accelerating the schedule for getting a successful product to market. Just as importantly, developers also have the chance to kill off a drug development program more quickly if the therapy is headed to an obvious failure.

"There's real value to failing faster," notes Rosenberg. Succeeding earlier with Abraxane, he also noted, pushed that blockbuster cancer drug into the market a year ahead of schedule.

Health Decisions will use the new trial model for a study it will conduct for Evofem, recruiting 2,800 patients for a Phase III study comparing Amphora contraceptive gel with a rival marketed vaginal contraceptive gel.

- here's the Health Decisions release