PATIENT-CENTERED OUTCOMES IN LATE-STAGE ONCOLOGY INDICATIONS – ARE MANUFACTURERS FOCUSING ON THE PATIENT?

Author(s)

Bastian AW*1;Ringwelski M1, Patel A2 1GfK Bridgehead, San Francisco, CA, USA, 2GfK Bridgehead, New York, NY, USA

OBJECTIVES: Drug manufacturers often struggle with the decision to include patient-relevant outcome measures into clinical trials while also trying to satisfy the demands of regulators and payers. In oncologic indications, where the diagnosis and management of cancer can have a significant impact on survival and patient and quality of life (QoL), more focus is therefore being placed on the quality of extended survival for cancer patients. Here, we examine inclusion of patient reported outcomes (PROs) as primary or secondary QoL endpoints for the top ten oncology indications currently in Phase III development. METHODS: Pipeline drug candidates from Adis R&D Insight database were collected with clinical development details for all late-phase (Phase II/III or Phase III) drug candidates in the top ten oncology indications. Trial details were further examined via ClinicalTrials.gov. An analysis was then conducted to determine how frequently drug trials are incorporating patient-relevant outcomes into their clinical development programs. Results were categorized into five clustered PRO categories RESULTS: Over 140 drug candidates and 304 clinical trials were identified. In these trials, only 11 included PROs as a primary endpoint. As secondary endpoints PROs were much more common, appearing 184 (60.5%) occasions. A total of 54 different PRO endpoints were utilized to measure QoL. Generic Non-Cancer measures (9.5%), Specific Non-Cancer measures (9.9%), General Cancer-Specific measures (16.1%), Symptom-Specific Cancer measures (6.3%), and Unspecified/General measures (18.8%) were utilized by manufacturers. EQ-5D was the most commonly specified measure (7.6%), followed by EORTC QLQ C30 (6.3%) CONCLUSIONS: Drug manufacturers are largely including PROs into oncology trials. However, the selection of measures is inconsistent and opportunities still exist to collect further QoL data by including PROs in trials where such measures are absent. Aligning the demands of payers, physicians and patients would help to incentivize a more standardized inclusion of PROs with greater frequently in oncology development programs

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PRM27

Topic

Methodological & Statistical Research, Real World Data & Information Systems

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference, PRO & Related Methods, Reproducibility & Replicability

Disease

Oncology

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×