Digital Health Applications for Pharmacogenetic Clinical Trials.
Hetanshi NaikLatha PalaniappanEuan A AshleyStuart A ScottPublished in: Genes (2020)
Digital health (DH) is the use of digital technologies and data analytics to understand health-related behaviors and enhance personalized clinical care. DH is increasingly being used in clinical trials, and an important field that could potentially benefit from incorporating DH into trial design is pharmacogenetics. Prospective pharmacogenetic trials typically compare a standard care arm to a pharmacogenetic-guided therapeutic arm. These trials often require large sample sizes, are challenging to recruit into, lack patient diversity, and can have complicated workflows to deliver therapeutic interventions to both investigators and patients. Importantly, the use of DH technologies could mitigate these challenges and improve pharmacogenetic trial design and operation. Some DH use cases include (1) automatic electronic health record-based patient screening and recruitment; (2) interactive websites for participant engagement; (3) home- and tele-health visits for patient convenience (e.g., samples for lab tests, physical exams, medication administration); (4) healthcare apps to collect patient-reported outcomes, adverse events and concomitant medications, and to deliver therapeutic information to patients; and (5) wearable devices to collect vital signs, electrocardiograms, sleep quality, and other discrete clinical variables. Given that pharmacogenetic trials are inherently challenging to conduct, future pharmacogenetic utility studies should consider implementing DH technologies and trial methodologies into their design and operation.
Keyphrases
- healthcare
- clinical trial
- patient reported outcomes
- electronic health record
- end stage renal disease
- public health
- mental health
- phase ii
- sleep quality
- phase iii
- ejection fraction
- newly diagnosed
- health information
- study protocol
- palliative care
- chronic kidney disease
- prognostic factors
- physical activity
- peritoneal dialysis
- pain management
- heart rate
- risk assessment
- health promotion
- adverse drug
- current status
- deep learning
- health insurance
- neural network