Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.

Evaluation of the effectiveness of drug risk-minimisation measures is mandatory for both risk evaluation and mitigation strategies (REMS) in the United States and risk management plans in the European Union (EU-RMPs). Such evaluations aim to assess the impact of risk-minimisation measures on the knowledge, attitudes or behaviours of healthcare professionals or patients, the incidence of safety concerns, and their impact on the overall benefit-risk balance. Although many effectiveness evaluation models and methods are available, regulatory guidance and policy are still evolving.

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis.

A therapeutic area review of oncology products and players.

This article reviews the dynamics of the oncology market and treatment trends and provides strategic guidance to those concerned with new product discovery and development. Cancer is the therapeutic area of highest potential, with an annual market value expected to be in excess of US 40 billion dollars in 2020. The global incidence of cancer cases is forecast to more than double over the next 20 years.