Observational research and labeling comprehension study experience

Disease Area Sample  Product Type of Research Study Methodology
Allergy Patients and Parent Caregivers Injectable Drug/
Device combination
Observational study pre-market assessment of
usability and attitudes towards a new drug delivery
device
One-on-one interviews
Asthma Patients and Parent Caregivers Inhaled Drug/
Device combination
Observational study and pre-market assessment on
probable use patterns and attitudes towards new inhaler technology
Web-based Survey
Dermatology Patients Injectable Aesthetic Observational study and pre-testing of a patient
package insert for readability and comprehension
One-on-one interviews
Diabetes Patients Injectable Drug/
Device combination
Observational periapproval study on product
usability and comprehension of patient package
insert
One-on-one interviews
Epilepsy Patients and Parent Caregivers Rectally administered Drug/Device combination Observational periapproval study on product usability and comprehension of patient package insert One-on-one interviews
Epilepsy Pharmacists Rectally administered Drug/Device combination Observational periapproval study on dose preparation and understanding of instructional materials One-on-one interviews
Epilepsy Patients and Parent Caregivers Rectally administered Drug/Device combination Phase IV Patient Registry to measure pharmacy dispensing performance and patient understanding Survey
Gastro-esophageal Reflux (GERD) Patients Orally administered Drug capsule Pre-Market Product Evaluation for new oral GERD medication including swallow test One-on-one interviews
Oncology Patients Injectable Drug/Device combination Observational study and pre-testing of instrucrtions for use for readability and comprehension One-on-one interviews
Oncology Patients Injectable Drug/Device combination Observational study and pre-testing of a Medication Guide for readability and comprehension One-on-one interviews
Pain Patients Inhaled medication Observational periapproval study on product usability and comprehension of instructions for use One-on-one interviews