Oct. 10, 2007
| Adaptive trials require fast decision-making by study sponsors and research teams, and Michael Rosenberg built a clinical research organization 18 years ago to help. The “tactical component” of adaptive trials — continuously tracking enrollment and better matching monitors to need — isn’t a new idea, says the founder and CEO of Health Decisions (Chapel Hill, N.C., and Oxford, U.K.). But, like sample size reassessment and dose finding on the strategic side, it remains the approach less taken because of hopes placed on Web-based electronic data capture (EDC).
|Michael Rosenberg|| |
Fast, clean data and performance metrics are the key criteria for doing adaptive trials of any type, says Rosenberg. That also describes the two major disadvantages of EDC. “Someone needs to enter data by hand, and that inevitably leads to delays. The interval between when data is generated and when it’s entered can take a couple of days and, more often than not, a couple of weeks,” he says. Moreover, Rosenberg continues, “They miss the most important management component of a study, which has the most profound implications for study timelines and budgets.” Years ago, Health Decisions shaved 1.6 years off a five-year timeline and $32 million off a $100 million budget for a six-nation Alzheimer’s study using performance metrics to guide managerial decisions.
That was even before better data input devices, such as Health Decisions’ optical SmartPen, came along, says Rosenberg. The SmartPen records strokes as case report forms are filled out and then docks in a computer station, transmitting data from the device to a central, Web-based database within seconds.
The combination of strategic and tactical components of the adaptive approach is “no less important than the introduction of the assembly line was for the auto industry,” says Rosenberg. All trials today should incorporate some elements of adaptive trials, he says, “especially on the tactical side. If you don’t consider these elements, you’re leaving something on the table.”
The inefficiencies of conventional study management techniques are mind-boggling, says Rosenberg. It generally takes a week to access key study progress metrics like site enrollment statistics. “We keep track of what’s going on every single minute at every single site and make this [information] available in real time to all study personnel, 24/7,” says Rosenberg.
The upfront, per-patient cost of the adaptive approach is no more expensive than traditional methods, says Rosenberg. The savings are on the back end. The hard part is the number of unknowns, such as the duration of a trial. “Sponsors sometimes get overly optimistic about how long it will take to recruit patients,” says Rosenberg. “The risk is great so the payoff is great, too. To minimize risk, we make decision-making the best it can be.”
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