Two therapies are placed in head-to-head clinical trials when they are compared against each other as opposed to a standard of care. When multiple treatment options are available to patients, a head-to-head clinical trial can establish how well these treatments compare to each other.

In 2020, Cytel pioneered two “Head-to-Head Comparisons using Real World Data” studies, one in oncology one in cardiovascular disease. The conduct of these investigations can be followed through a Cytel webinar series, which includes Professor Miguel Hernan of Harvard University’s TH Chan School of Public Health.

Head-to-Head Clinical Trials

Comparisons of competing interventions are essential to determine value of medicines, both from clinical and societal perspective. Cytel are forerunners in implementing novel methods like head-to-head comparisons. Our pilot projects occurred in real time across Cytel’s webinar series where our experts talked about the data and analytical challenges faced during the projects, and how these challenges are overcome.

The first webinar in this series, introduces the concept of head-to-head comparison using real world data (RWD). With head-to-head studies rare, HTA bodies rely on NMA techniques to derive the necessary estimates and incorporate them into cost-effectiveness models. The use of RWD for head-to-head comparison purposes was often challenged due to data limitations and difficulty to draw causal conclusions. Recent developments are challenging this status quo. The increased availability of regulatory-grade RWD helps. We can now also avoid some of the biases that used to plague the use of observational data. Head-to-head comparisons using RWD through emulation of target trials successfully deal with most of these biases.

In the webinars that followed, our experts reviewed the pilots but also focused on applications of this method.

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