Post-marketing surveillance studies are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures. In this article we look at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s).
There is growing evidence that the increased frequency and severity of adverse drug events has contributed to the negative impact on patient’s health status. Also, it should be noted that observational studies can further characterise the effectiveness and safety of medicines in real-world clinical settings.
What Are Post-Marketing Surveillance Studies?
Post-marketing surveillance studies are also referred to as ‘post-authorisation safety studies’ (PASS) or ‘phase IV trials’, are an example of this type of research.
- In contrast to the controlled settings of pre-marketing trials, these studies are not rigorously controlled, and can provide valuable information on the use of drugs in the general population as well as in special patient populations (elderly patients, pregnant or breast-feeding women, children, patients with multiple comorbidities, etc.).
- A PASS or a phase IV trial might be proposed as a part of a marketing authorization or specific obligation.
- In addition, post-marketing surveillance studies may be planned as a requirement in the Risk Management Plan (RMP) as an additional pharmacovigilance activity to evaluate the effectiveness of risk management measures.
Post-Marketing Surveillance Study Guidelines
The development of PASS (post-authorisation safety studies) protocols is guided by the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices, Module VIII—Post-Authorization Safety Studies (Guideline on Good Pharmacovigilance Practices (GVP) Module VIII – Post-authorisation safety studies (Rev 2).
Post-authorisation safety studies are often multi-country studies, designed according to strong scientific principles, and should provide long‐term follow‐up data and the quantification of specific risks. Statistical methods, including sample size considerations (e.g., risk level that can be detected) are of the greatest importance.
It is important to understand the link between PMS studies and RMPs since the primary purpose of the RMP is safety surveillance. Given the specific definition of PASS in the context of RMP, the adequacy of pharmacoepidemiological methodology needs to be assessed on a case‐by‐case basis.
PASS provides critical information for regulators, public health agencies and manufacturers. Collaborative approaches and synergistic efforts between manufacturers and key stakeholders are needed to facilitate access to data and to drive optimal study design and implementation.
We Can Help
If you require assistance in undertaking a Post-marketing surveillance study, we can assist you. Our Medical & Clinical team has extensive experience in the sector. Contact us on 00353 52 61 76 706 or complete the form on our Contact Us page and we will get back to you.
References:
- European Medicines Agency . Guideline on good pharmacovigilance practices (GVP) – Module VIII: Post‐authorisation safety studies (Rev 2). Doc. Ref. EMA/813938/2011 Rev 2;
- Hoekman J, Klamer TT, Mantel‐Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow‐up of post‐marketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol 2016; 82: 213–26.
- Public Policy Committee International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP) Pharmacoepidemiol Drug Saf 2016; 25 (1):2-10.
- Carroll R, et al. : Dataset 1 in: An Analysis of Characteristics of Post-Authorisation Studies Registered on the ENCePP EU PAS Register. F1000Research. 2017;6:1447.
