With the escalation of new market drug prices, a drive to better identify patients who will gain therapy benefit has increased. Clinical trial accrual has traditionally favored the enrollment of non-Hispanic whites and patients living in urban areas.⁹⁻¹² So, in June 2024 the FDA released guidance to increase clinical trial recruitment of underrepresented groups.¹³ By enhancing trial participation to include various groups, this increases the potential to identify real world responses and toxicities and decrease generalization currently applied to these high-cost therapies. As the identification of patients who benefit from therapy improves, there is the potential to optimize resources and provide greater value.  However, the current FDA stance on this guidance is not clear.¹⁴ 

Some factors that contribute to disparities in therapy participation include clinical trial accrual, health care resource availability, cancer program knowledge and comfort with novel therapy administration and side effect management along with financial burden associated with therapy cost.¹² 

To improve the range of patients treated with these novel drugs some solutions include the creation of clinical trials that include safe outpatient alternatives for step up dosing administration to decrease inpatient admissions,  a dosing schedule that allows for longer duration between treatments to decrease financial burden associated with travel, and the potential for home or self-administration to enhance convenience and decrease patient out of pocket expenditure.¹²

The inclusion of a variety of patient groups will aid in the identification of the best patient population that benefits from therapy. This understanding is vital for improving patient outcomes and managing health care costs.