Let’s talk adaptive trial design, particularly as it pertains to early clinical research right now. Both large and small pharmaceutical companies see the potential to shorten development timelines using adaptive trials.
The Tufts Center for the Study of Drug Development estimates that about 20% of clinical trials now employ some type of simple adaptive design. Their 2013 report on adaptive trial design notes that companies are doing it for a variety of reasons from making faster go/no-go decisions with early study terminations via futility analysis to saving significant sums in development costs. The report also states that “more sophisticated adaptive designs applied to exploratory phase clinical trials hold strong potential to impact success rates in later phase development.”
More trial designs now include patient arms to generate pharmacokinetic and pharmacodynamic data. Adaptive trial designs are continuing to push the boundaries by not only incorporating patient arms into a SAD or MAD trial design but also adding food effect arms.
When one extrapolates the trend and desires to obtain, for example, additional cardiovascular safety data in these trials (to potentially avoid the tQTC trial) one is now designing very complex trials that necessitate a higher level of scientific oversight and input than was traditionally incorporated into standard Phase I/IIa studies.
This trend is pushing contract research organizations to become more sophisticated and enhance their capabilities either through collaboration or organic growth of additional expertise. One of the differentiators as adaptive trial design implementation becomes more commonplace may be access to patients for trial participation. Organizations can benefit by designing their structures such that they can recruit both healthy volunteers and a variety of patient populations within their current site structure or partner with other CRO’s for expanded access to patients for trials. Depending on the complexities of the different populations, how their medical conditions are managed, and the logistical challenges they pose, many long term providers of early clinical research studies may collaborate more freely with patient-centric sites.
At DaVita Clinical Research we have built an early clinical research service that can perform highly complex phase I and IIa studies at hospital-based facilities, and we collaborate with an expert in Phase I trial design, Jon Ruckle, to customize solutions for our clients. We have access to patient populations as well as healthy volunteers, and have experience managing trial participants with co-morbid conditions. If you want to chat about a Phase I trial you’re planning, reach out to me directly at Kevin.Goudreau@davita.com.
-Kevin Goudreau, V.P. Commercial Development