Therapeutic Area
Project Description
Central Nervous
System
System
Developed and implemented a patient-reported outcomes questionnaire assessing work loss/work productivity, resource utilization, use of assistive devices and caregiver services, and treatment satisfaction in a Phase IIIb clinical trial of early Parkinson’s Disease patients. Patients were followed by telephone for 1 year following enrollment into the study.
Analyzed patient-reported outcomes data from a Phase IIIb clinical trial of patients with moderate to severe, non-malignant pain.
Women’s Health
Developed and validated a questionnaire to evaluate satisfaction in women using one of four types of hormonal contraceptives.
Oncology
Provided recommendations and developed strategic plans for the implementation of patient-reported outcomes measures in various clinical trials (e.g., colorectal, thyroid, pancreatic, and non-small cell lung cancer).
Conducted a time and motion study in which the staff observed resource use associated with administering treatment and managing any subsequent reactions to treatment over a 10-day period of time. Health care costs and indirect patient and caregiver costs were also estimated.
Endocrinology
Conducted two online survey studies. One was a qualitative survey of PCPs who treat type 2 diabetic patients; the other administered a survey to patients with type 2 diabetes who use insulin.
Gastroenterology
Developed a questionnaire to assess gastrointestinal symptoms in patients taking a medication that treats bone loss. Conducted a study in community practices to test the reliability and validity of this questionnaire.
Dermatology
Tested the reliability and validity of a newly-developed questionnaire for patients with toenail onychomycosis; computed the minimal clinical important difference.
Obesity
Undertook a qualitative interview study in order to more fully understand how overweight individuals describe feelings of appetite, hunger and satiety and to examine the content validity of two questionnaires related to these concepts.
Genitourinary
Assessed the psychometric properties of a PRO questionnaire in men with lower urinary tract symptoms associated with BPH. Undertook a gap analysis based on these findings to guide the conduct of additional work to be completed in accordance with draft PRO guidance.
