The idea of using interim data from in progress trials to modify – or adapt - protocols has become well established over the past 10 years with sponsors, contract research organisations (CRO) and regulators recognising the potential efficiency benefits.
But while sponsors may say they want adaptive approaches, data from a recent Tufts study suggests that although there has been a slight up-tick in demand for flexible designs that allow for the early termination of unpromising trials, overall adoption rates are still low.
Mark Shapiro, executive director of clinical development at CRO Clinipace, told Outsourcing-pharma.com that risk averse “smaller biotech and pharma companies are waiting to see what the larger companies are doing.”
This was echoed by Clinipace executive vice president Barb Geiger, who said all of the top CROs can conduct trials with some type of adaptive approach, and the expertise of the larger CROs is beginning to outpace sponsor demand.
Despite this Geiger still believes that the adaptive trial design market will grow in time as sponsors “will be reaching in new directions for advice from their partners.”
Post-Blockbuster Adaptations
Vlad Dragalin, senior VP at adaptive trials specialist Aptiv Solutions was similarly positive. He told Outsourcing-pharma.com that now the blockbuster drug era is over sponsors will want to target more specific populations, which means adopting a flexible approach.
Luis Gutierrez Jr, Aptiv’s COO, agreed, adding that the US Food and Drug Administration (FDA) is encouraging sponsors to take on more adaptive approaches, although he said the agency should finalize guidance on the topic.
Gutierrez Jr also cited trends within the services sector to support the predicted growth in demand. He explained that a year ago only two CROs were discussing adaptive trials, but now there are seven or eight jumping on the “me-too bandwagon,” including almost half of the largest ones.
Other Approaches
One of the largest CROs – Quintiles - is using what some might call an adaptive approach with its new Infosario tool. Cara Willoughby, senior director at Quintiles, told Outsourcing-pharma.com they are rolling it out with Eli Lilly and another unidentified partner.
The tool can tease out trial designs by cross-referencing ICH and FDA guidelines, as well analyzing the impact of exclusion and inclusion criteria for patients enrolled in a trial or increasing a company’s quantitative risk analysis.
Regardless of whether sponsors will take on this disruptive technology or others, CROs seem confident that sponsors will need their experience moving forward.