PhaseV has partnered with contract research organization (CRO) Quanticate to improve the speed and quality of clinical development programs to help biotech’s and sponsors perform more advanced and efficient clinical trials by using adaptive trial designs.

The new partnership harnesses Hertfordshire, UK-based Quanticate’s flexible solutions for data management, biostatistics and statistical programming, along with the Boston-based PhaseV’s proprietary software and ML platform for adaptive trial designs.

CEO of Quanticate, David Underwood, said: “There is currently a great need in the pharmaceutical industry to leverage flexible, dynamic, and adaptive trial designs based on simulations, bayesian-statistics, machine learning and accumulation of data throughout a trial while continuing to maintain the highest scientific integrity. PhaseV’s platform allows trial teams to seamlessly evaluate and execute all types of designs. We are pleased to enhance our services and foster drug development innovation through this collaboration.”

The decision process is split into three stages: consultation, review and implementation. First, a specialist consultation with Quanticate’s internal statisticians or PhaseV’s experts will take place to establish whether a study may benefit from adaptive designs using the PhaseV platform.

PhaseV and Quanticate will then work together to create a prospective design to ensure the solution fits the unique requirements of a sponsor’s study, review together with the sponsor, and make adjustments to ensure it fits the trial protocol. Once all parties agree to the design, the trial is initiated.

CEO of PhaseV, Dr. Raviv Pryluk said: “Adaptive trials have the potential, if adopted at scale, to increase the throughput of clinical development by an order of magnitude. However, for that to happen, sponsors need to overcome some major challenges including operational and data implications of a given trial.”

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The gold standard of trial design is the randomised controlled trial (RCT), however, in some indications, this is not a feasible trial design.

Adaptive trials are used in nearly every therapeutic area to promote more efficient and precise clinical trials. However, there are fields in which the adoption of adaptive design is much wider than others, and rapidly growing, such as oncology, cell and gene therapy, neuroscience, immunology, and rare diseases.

Adaptive designs allow sponsors to leverage data from a trial to make adaptations and adjustments and allocate patients and treatment based on observed response. As a result, efficacy can be increased, fewer patients are required, research and development costs can be reduced and candidates can get to market quicker.

There are challenges to adaptive trial designs however including operational burden, complexity, and lack of familiarity.