Precision dosing: A clinical and public health imperative

The objective of precision dosing is to achieve the best treatment outcome with as little toxic tradeoff as possible, but FDA’s Kimberly Maxfield, PhD, and Issam Zineh, PharmD, MPH, say there is still much road to cover to reach that goal. In order to truly maximize the benefit/risk balance of a drug for individual patients, the authors believe optimized dosing must consider subpopulations of patients—rather than one specific demographic—during the drug development process. In that same vein, researchers will need to examine different responses in patient populations or clinical settings that are underrepresented in preapproval studies. This data, in turn, can inform prescription drug labeling and/or practice guidelines. In terms of clinical practice, Maxfield and Zineh acknowledge that the current landscape “is mostly not conducive to incorporation of the precision dosing approaches and technologies.” They blame limited clinician training and a lack of clarity on incentives for payers to provide reimbursement. To overcome this challenge, the pair recommend that physicians, pharmacologists, and informaticians share their insights on precision dosing by holding workshops or symposia, participating in the design or conduct of precision-dosing studies, and/or developing a drug-disease framework that spells out when precision dosing might add value. “Continued advancement of precision dosing-enabling activities should be a priority,” the authors conclude, “and strong representation from patients and clinicians, who have been underrepresented in discussions about precision dosing to date, is essential.”