Table 1:

Challenges and solutions discussed in the panel sessions for precision dosing in the real-world setting

Challenge identified	Solution offered
Current drug labeling practices discourage individualized dosing in the clinic	• Use broader labeling language to encourage the use of exposure-response data within the studied range of safe and effective doses in the clinic
There is a lack of data to inform precision dosing approaches	• Create an FDA repository of de-identified subject-level data to help develop precision dosing tools
	• Encourage the use of multiple drug doses or titration-based dosing during clinical trials
Clinical trial populations do not represent real-world patients	• Enroll understudied and more diverse populations to inform dosing in real-world settings
	• Use innovative clinical trial designs to enable the enrollment of subpopulations
There is a lack of predictive models for major drug clearance mechanisms	• Create a process for agreeing that a model is useful for predicting a clinical dose
There is a lack of real-world data to inform and confirm precision dosing	• Identify real-world data sources capable of providing adequate information regarding efficacy and safety to help predict precise doses for certain clinical patient subgroups (e.g., children, pregnant women, obese subjects)
Drug labeling lags behind advances in science and knowledge from real-world use	• Create more dynamic drug labels that can be modified and disseminated in reaction to real-world data post marketing
There is a lack of clarity on regulatory pathways for clinical decision support tools	• Create and improve FDA guidance regarding the appropriate regulatory approval pathways for clinical decision support tools and devices
The culture of the healthcare industry does not broadly support precision dosing approaches	• Increase training on quantitative modeling and simulation for clinicians and pharmacists to champion this approach to patient care
	• Increase the understanding of how precision dosing increases the value of health care encounters and improves patient outcomes
	• Incentivize precision dosing approaches at the bedside by providing increased reimbursement for these value-based approaches
	• Encourage patient activism to increase awareness of the benefits of precision dosing and barriers to access
There is a lack of efficient and user-friendly CDS tools	• Develop precision dosing tools that integrate into clinical work flows and add value over the standard of care