PURPOSE:

Administrative claims data are the conventional source of generating real-world-evidence (RWE) for patient journey evaluation. Significant gaps in understanding patient outcomes exist using this data. Integrating COA’s in real-world-data (RWD) is critical for health care and pharmaceutical organizations to better understand and address patients’ needs, including electronic health records, medical charts, patient/provider surveys. Claims identified samples for RWE data collection enhances study validity. Applications of these findings have meaningful real-world implications for treatments and patient care. Audience participation includes polling questions engaging the audience (e.g., how many audience members have worked with administrative claims data that includes COA's?)

DESCRIPTION:

Dr. Bennett will provide an overview (8min) defining COA’s and associated gaps within the context of RWD: a)Patient reported outcomes (PRO’s) –patient self-report surveys/interviews, b)Observer Reported Outcomes (ObsRO) –observer outcomes, caregiver/parent report c)Clinician reported outcomes (ClinRo) –provider surveys or clinical notes d)Performance outcome (PerfO) assessments on standardized tasks.

Dr. Taylor will examine how does EHR data (structured/unstructured) enhance the use of RWD (12 min). Includes the significance of data such as tests ordered, screenings/assessments, AE’s, HCU visits, and clinical notes. Discussion on pros/cons for this strategy.

Dr. Tkatch will discuss the use of self-report data collection generating RWE (12min). Assessments measuring provider/patient/caregiver experience. How are claims and surveys used concurrently to generate valuable RWD? Use of claims for patient identification and linking assessments back to claims for HCRU and clinical outcomes analysis.

Dr. Rosenblatt will explore applications of COA generated RWE (12min). How is data used to benefit the patient experience? Can RWE COA data impact the development of treatments or the expansion of current treatments? Can RWE help physicians in treatment decisions, and can it be used to inform treatment guidelines? How can RWE be utilized in regulatory applications or decision-making around drug development and approval?

Audience participation (20min)