Pursuing Protocol Designs That Maximize The Value Of Hybrid Clinical Trials

By Graham Wylie, Executive Chairman, Medical Research Network

In the pharmaceutical industry, clinical trials are designed to address a hierarchy of drivers – from efficacy to safety, comparability to compliance, there are a slew of considerations that are vital to conducting a successful study. There are also factors that, while not necessary for regulatory approval, are nevertheless important to ensuring a trial itself is efficient, fast, and tailored to its patient population.

Hybrid clinical trials, which have existed in some form for decades, have seen renewed interest in recent years, owing to increasing trial complexity, the need for greater accessibility across patient populations, and the need for more flexibility to respond to emergent situations like the COVID-19 pandemic. While the pandemic served to spur unprecedented investment in hybrid clinical trial models in order to facilitate and accelerate vaccine trials, geopolitical and macroeconomic factors post-pandemic, coupled with a widespread slump affecting emergent hybrid clinical trial tech companies following a peak in innovation, have slowed the rapid adoption of these technologies. Today, industry players have entered a “normalization” phase, a slow and sustained recovery marked by another increase in adoption and greater technology integration across the space.

The future of hybrid clinical trials hinges on facilitating speed, cost-effectiveness, and data accuracy while ensuring regulatory compliance. The best protocol designs are patient centric – by prioritizing patient experience during trial design, sponsors can maximize the value of hybrid clinical trial solutions, balancing technology elements with in-home care, site visits, logistics, and other key variables to arrive at the right trial design.