Sponsors and CROs are familiar with the definition of feasibility as the process of evaluating whether, and how, a clinical trial can be conducted successfully. This approach to feasibility typically looks backwards rather than forwards, drawing on historical data from internal
and external sources.

However, sponsors should not expect the set of conditions present at the start of the trial to remain unchanged. In this article, we discuss why feasibility must be redefined as continuous feasibility, an ongoing assessment of a trial’s ability to be successfully executed at operational,
regulatory, site and patient levels.

Redefining Feasibility as a Continuous and Evolving Process

In the changing oncology landscape, enrollment challenges can arise unexpectedly. A phase 3 study in multiple myeloma was initially enrolling smoothly across Europe. However, midway through the enrollment period, the participation curve flattened unexpectedly.

The reason behind this sudden change was the approval of daratumumab, a new monoclonal antibody with NHF reimbursement that was quickly adopted as the new standard of care (SoC) for this indication. Facing a 30% drop in interest among potential trial participants, the once-promising study was now at severe risk of missing its enrollment targets.

Fortunately, the research team had been proactively monitoring the approval status of emerging therapies. With a well-prepared contingency plan, they were able to quickly adapt by opening enrollment in countries and sites that had not yet adopted daratumumab as their standard treatment option.

From shifting standards of care and disparities in global drug access to the operational demands of emerging treatment modalities, such as multispecific antibodies, radiopharmaceuticals, cell therapies and antibody-drug conjugates (ADCs), today’s oncology research landscape is evolving. Our approach to feasibility must evolve as well, monitoring market competition and evolving SoCs closely and continuously,