The Growth of Phase IV Trials and the Need to Demonstrate Effectiveness Using Electronic Patient Reported Outcomes

Patient centricity is now at the forefront of drug development, from early understanding of Burden of Disease through to Comparative Effectiveness Research and the use of Real World Data to generate evidence on the patients’ perspective of outcomes and quality of life. With the rise in patient centricity, we see the growth for the need of Patient Reported Outcomes (PRO) and associated technologies allowing these outcomes to be collected and leveraged to meet the needs of multiple stakeholders including Patients, Patient Advocacy Groups, Payors and Pharma.

Pharmaceutical companies must now satisfy the value perceptions of multiple stakeholders, including payers, to attain market access for products. Regulatory approval is an essential and necessary step in market authorisation, but Market Access is no longer guaranteed.

This paper therefore seeks to address and describe the growing need to satisfy the value perception of multiple stakeholders and the importance of Late Phase trials capturing Clinical Outcome Assessments (COA) and specifically electronic Patient Reported Outcomes (ePRO) in relation to this.


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