Complying with EU regulations on adverse event data in new medicine trials
In clinical trials for new medicines, the interaction between manufacturers and patients is critical in soliciting and recording potential safety data that contributes to helping patients benefit from information about, and ultimately access to, new treatments. The involvement of potentially many parties in a patient support programme (PSP) makes communication inherently complex. A PSP that considers the requirements of all stakeholders should incorporate pharmaceutical suppliers, regulators, front line staff, and third-party contractors.
PSPs have typically not been designed as organised data-collection systems, and the majority of adverse event (AE) reports are often non-serious and expected. However, manufacturers should consider the potential impact of managing high volumes of safety data received from PSPs.
In “Seven Elements of Managing Safety Data in Patient Support Programmes” Navigant Life Sciences professionals outline the regulations on communication with patients subject to EU privacy directives, and pharmacovigilance obligations for AE reporting — amid increased regulatory scrutiny of PSPs.