Recently, our chief scientific officer, Ron Marks, and our vice president of clinical development, Mark Shapiro, wrote an article on adaptive trial design for International Clinical Trials. They discussed the expansion of adaptive trial designs, as well as their potential benefits and industry concerns.
As clinical trials are increasingly becoming more expensive, organizations are seeking innovative solutions, often in the form of adaptive trials, to accelerate development and reduce failures. The purpose of an adaptive design is to objectively use study data to make valid changes that allow for shorter development times and less costly path to achieve the trial’s objective(s).
Adaptive designs also help address uncertainties in clinical trials, allowing investigators to review accumulating data and possibly make modifications. However, fast, reliable electronic data collection is mandatory for these designs, requiring advanced technology.
According to the 2010 FDA draft guidance, adaptive approaches may lead to a study that more efficiently provides the same information, increases the likelihood of success in achieving the study objective, or yields an improved understanding of the treatment’s effect. In addition, the flexibility of an adaptive design can lead to trials with fewer patients—making enrollment easier to achieve—and fewer patients treated at ineffective doses. In other words, adaptive designs minimize participants’ exposure to potentially harmful and ineffective treatments.
So while the overall adoption rate remains low at this point in time, many industry leaders believe the adaptive trial design market will increase significantly over the next few years as sponsors seek new directions for clinical development and regulatory agencies finalize guidance on the topic.
To read the full byline, click here.