WEB-RADR 1 Work Packages

Work Package 1: Governance and policy

Work Package Lead: European Medicines Agency (EMA). Other partners involved: MHRA, HALMED, LAREB, Novartis Pharma, Janssen Pharmaceutica, Sanofi-Aventis Research & Development, UCB, Amgen.

Work Package overview: Recommendations were developed by WP1 on the use of mobile devices and social media for the purpose of reporting ADRs, and the monitoring of safety medicines authorised in the EU.

The EMA’s Health Care Professionals Working Party (HCPWP), the Patients and Consumer Working Party (PCWP) and the EudraVigilance Expert Working Group (EV-EWG) were consulted to ensure stakeholder input throughout the project. Technical expertise ensured compatibility of Individual Case Safety Report (ICSR) reporting standards, and associated product dictionaries.

 

Work Package 2A: Social media

Work Package Lead: Epidemico. Other partners involved: Novartis Pharma, Janssen Pharmaceutica, AstraZeneca, UCB.

Work Package overview: WP2A assessed social media data via a visualisation platform for signal identification and confirmation. Formal analysis of emerging social media data was then undertaken to see if better predictions of marketed medicines products was possible and could inform better design of future medicines products. As these data had not previously been used for safety surveillance, careful consideration was given as to how to process within data protection requirements.

 

Work Package 2B: Analytics

Work Package Lead: Uppsala Monitoring Centre (UMC). Other partners involved: University of Liverpool, Epidemico, Novartis Pharma, Janssen Pharmaceutica, Bayer, AstraZeneca, UCB, Sanofi-Aventis Research & Development

Work Package overview: The WP2B Team developed and linked new and existing analytical tools for the analysis of social media content for pharmacovigilance purposes. The quality and relevance of data extracted from social media sources was improved, as well as the subsequent use in the detection of safety signals. Areas of focus included suspected ADR identification, record linkage of duplicate reports, and signal detection.

 

Work Package 3A: Mobile reporting platform

Work Package Lead: Epidemico. Other partners involved: SRDC, Uppsala Monitoring Centre, Novartis Pharma, Amgen, Janssen Pharmaceutica, UCB, Sanofi-Aventis Research & Development

Work Package overview: The WEB-RADR mobile application was designed and created by WP3A, engaging both the public and healthcare professionals around issues of real-time pharmacovigilance. The app was launched in the UK (Yellow Card), the Netherlands (LAREB) and Croatia (HALMED). The app was later  piloted in Burkina Faso and Zambia through collaboration with the World Health Organisation (WHO). For more information about the mobile app, please see the Mobile Apps page.

 

Work Package 3B: User based evaluation

Work Package Lead: University Medical Centre Groningen (UMCG). Other partners involved: University College London, EURORDIS, Amgen, Novartis Pharma

Work Package overview: WP3B evaluated the mobile app for reporting ADRs and accessing safety information. Studies undertaken comprised of qualitative research into motivations for reporting through an app and focus groups. Electronic surveys were also conducted to quantify the impact that each of the motivators identified has on reporters. In addition, the app prototypes developed in WP3A were evaluated for their usability. This work fed back to the project and into the iterative development of the mobile app.

 

Work Package 4: User based evaluation

Work Package Lead: University of Liverpool. Other partners involved: LAREB, Uppsala Monitoring Centre, University College London, Novartis Pharma, Janssen Pharmaceutica, Bayer, AstraZeneca, Sanofi-Aventis Research & Development, UCB, Amgen

Work Package overview: WP4 aimed to determine whether novel media applications (apps and social media) add value to existing pharmacovigilance methodologies. The position of social media within the hierarchy of evidence was explored, along with its use in signal detection and evaluation. In addition, adverse drug reaction (ADR) reports generated via the mobile app were compared to those received via established reporting schemes for completeness, quality and value for detection of safety issues. These reports app were benchmarked against those from traditional sources and their impact on signal detection evaluated.

 

Work Package 5: Project management and communication

Work Package Lead: MHRA. Other partners involved: Novartis Pharma

Work Package overview: This Team delivered the project coordination function, including dissemination and communication of information and running of administrative, financial and project processes. Yearly progress reports were submitted to the IMI to ensure quality assurance of the project.