Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance.
This paper from Deborah Layton and Saad A. W. Shakir describes a method for surveillance of products initiated by specialists in secondary care has just been published by the Drug Safety Research Unit (DSRU). The technique, “Specialist Cohort Event Monitoring” (SCEM), is a type of observational post-authorisation safety study ideally suited for Risk Management Plans (RMPs).
The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for ‘real-world’ post-authorization safety studies (PASS).
Predominantly non-interventional (however, a PASS may be a clinical trial), their main objective is to gather additional safety monitoring information or to assess a pattern of drug utilization.
The importance of pharmacovigilance (PV) activities and interventions, has increased dramatically with the evolution of European Union (EU) PV legislation requiring every new medicinal product to have a risk management plan.
There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS.
The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. SCEM studies are, by definition, observational studies to evaluate use of a drug in the naturalistic setting and fulfil the criteria for PASS. The underlying organizational construct of SCEM is that each study is essentially an organized system that uses observational study methods to collect uniform existing data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure.
The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring.
There are three features of SCEM that are relevant to any PASS: the firstis the need to understand how the widespread application of clinical guidelines, pharmacoeconomic policies and policies for reimbursement determine treatment choices. The second is that for a PASS that relies on contribution of patient data by experts, an appropriate strategy exists to cope with non-response and enhance response rates and at least, there is the need for a PASS to be adaptive.
A key strength of the SCEM is that through identification of cohorts of patients treated in secondary care, the design facilitates surveillance of a diverse patient population in hospital or under the care of specialists.
Read more on Drug Safety, February 2015, Volume 38, Issue 2, pp 153-163.
Free download on: http://link.springer.com/article/10.1007/s40264-014-0260-x