Phesi and Sensyne to collaborate on synthetic control arms for clinical trials

This partnership occurs in the context of the Covid-19 pandemic, which has dramatically affected the global clinical trials landscape. There have been concerns about trial enrolment and retention, both because of physical lockdown restrictions and concerns about patient health. In addition, many sites are no longer available for clinical trials as they, and their staff, have been requisitioned for both Covid-19 treatment and trials.

“While Covid-19 has hit the clinical trials infrastructure hard, it has also helped to highlight longstanding problems in the industry that urgently need to be addressed,” notes Li. Data and analytics are one solution to the challenges facing clinical research programmes.

Li adds: “By working together, Phesi and Sensyne can provide the data and analytics needed to help improve trial design and execution. Ultimately, remaining productive and innovative during this current [pandemic] period will be heavily reliant on an ability to make sense of, and be led by, data.”

Although the collaboration with Sensyne will support Phesi’s long-term aim to help life sciences companies broadly embrace data-driven approaches in their clinical work, the partnership will particularly focus on the appropriate use of synthetic control arms, instead of standard placebo groups, in clinical trials.

A synthetic control arm relies on data from other clinical trials and the real world in place of placebo arms, which have been criticised as ethically questionable, particularly for patients with severe diseases. Li points to “trials in late-stage cancers or progressive genetic disorders where a patient’s health would deteriorate were they to receive a placebo rather than the investigational treatment” as an example of the ethical implications of placebo arms.

In addition, “a synthetic control arm reduces the burden on sites and sponsors; fewer patients have to be recruited and all of those that are will be in the active arm of the trial,” states Li. Recruitment of patients is a major bottleneck in successful clinical trials; research suggests that more than 80% of clinical trials fail to complete enrolment on time.

“This partnership with Sensyne bolsters the amount of data available to clients to help identify opportunities where a synthetic placebo or comparator arm is feasible,” explains Li. The ultimate goal is “avoiding exposing patients to a placebo or comparator altogether”.

Li concludes that the use of synthetic control arms would be “a significant transformation in how new medicines are developed”.