Digital smart packaging solutions have been available to clinical researchers for many years. Adoption of these technologies have centered on a solution’s specific features and benefits to provide time-based audio and visual prompts to remind patients to take their medicine as directed by protocol. These solutions often incorporate companion smart phone applications and SMS text programs.
What is often overshadowed is the value of the individual data points that are passively captured at each medication dosing event. When these data points are viewed longitudinally over time, a deep understanding of an individual patient’s dosing behavior emerges that can be used to better understand not only how many doses a patient took but the time between doses. These highly precise and accurate drug dosing histories enable a better understanding of protocol adherence, safety, efficacy, PK/PD and a drug’s exposure-response relationship.
Key learning objectives:
- Review the benefits, and more importantly the downsides, of the non-digital techniques commonly used in clinical trials to measure patient drug exposure
- Understand how passively measured drug dosing histories can spotlight how a patient is executing a trial’s drug dosing protocol, and exactly how a patient is being exposed to study drug
- Appreciate the utility of the data for study population triage programs and for in-trial intervention programs