Planning, stats modeling needed for adaptive trials

Planning and statistical modeling are keys to success in adaptive trials. Compared with traditional clinical trials, some adaptive trials may require as much as six months' additional pre-trial planning, according to Nature.

But clinical trial statisticians, responsible for modeling the trials, are still hard to find. "You have to have the trial planned up front, to eliminate data bias," says Susan Bornstein, EVP at eClinical Solutions, in an interview. The statistical expertise comes from the drug-sponsor side, while Bornstein's team, comprising a division of Eliassen Group formed four years ago, provides clean data in a standardized and viewable format to aid in trial decision-making and reporting. 

"We hear a lot of questions about adaptive trials," she says. The solutions provider has the capability to set up and run such trials. "But we haven't gotten a statistical analysis plan yet. I don't think there's much happening now."

That may be changing. Nature reports a survey that identified 13 adaptive trials in 2007, compared with only three such trials or fewer each year between 2003 and 2006.

- here's the article