Common use of Project objectives and key deliverables Clause in Contracts

Project objectives and key deliverables. The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. The main goal of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. This will be achieved by developing a set of innovative tools and methods that will enhance the early detection and assessment of adverse drug reactions from different data sources, and enable the integration and presentation of data on benefits and risks. These methods will be tested in real-life situations in order to provide all stakeholders with accurate and useful information supporting risk management and continuous benefit-risk assessment. The main goal of PROTECT will be achieved by developing innovative tools and methodological standards aiming at: • Developing a comprehensive set of signal detection recommendations applicable to different databases based on extensive retrospective and prospective testing of existing and new methods for SD, creation of a structured database of known adverse drug reactions, and testing SD in electronic health records and clinical trials. • Better explaining discrepancies between PE studies of adverse drug events (AE), by developing a framework for PE to test and compare analytical methods to control for confounding and study 5 drug/AE pairs in several EU databases to identify and further explore sources of variability (i.e. hip fracture and antidepressants/benzodiazepines, acute liver injury and antibiotics, myocardial infarction and anti-asthmatic drugs, suicide and antiepileptics and cancer and calcium channel blockers). This includes exploring the best use of drug utilisation data in PE studies. • Exploring the feasibility and acceptability of early data collection on medication, lifestyle and risk factors directly from consumers via the internet and interactive voice response system in a study with 5,600 pregnant women from 4 countries, including data linkage to other sources where possible. • Developing methods for collating and integrating benefits and risks of medicines from various data sources as well as novel modelling approaches to allow continuous modelling of the benefit-risk along the lifecycle of products and its graphical representation for use by patients, healthcare prescribers, regulatory agencies, and drug manufacturers. • Testing and validating various methods developed in PROTECT using a large variety of different sources in the EU (including disease registries) in order to identify and help resolve operational difficulties linked to multi-site investigations. • Disseminating the methodologies developed in PROTECT. This will be enhanced by making use of existing and also developing new training and educational activities.

Project objectives and key deliverables. The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. The main goal of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. This will be achieved by developing a set of innovative tools and methods that will enhance the early detection and assessment of adverse drug reactions from different data sources, and enable the integration and presentation of data on benefits and risks. These methods will be tested in real-life situations in order to provide all stakeholders with accurate and useful information supporting risk management and continuous benefit-risk assessment. The main goal of PROTECT will be achieved by developing innovative tools and methodological standards aiming at: •  Developing a comprehensive set of signal detection recommendations applicable to different databases based on extensive retrospective and prospective testing of existing and new methods for SD, creation of a structured database of known adverse drug reactions, and testing SD in electronic health records and clinical trials. •  Better explaining discrepancies between PE studies of adverse drug events (AE), by developing a framework for PE to test and compare analytical methods to control for confounding and study 5 drug/AE pairs in several EU databases to identify and further explore sources of variability (i.e. hip fracture and antidepressants/benzodiazepines, acute liver injury and antibiotics, myocardial infarction and anti-asthmatic drugs, suicide and antiepileptics and cancer and calcium channel blockers). This includes exploring the best use of drug utilisation data in PE studies. •  Exploring the feasibility and acceptability of early data collection on medication, lifestyle and risk factors directly from consumers via the internet and interactive voice response system in a study with 5,600 pregnant women from 4 countries, including data linkage to other sources where possible. •  Developing methods for collating and integrating benefits and risks of medicines from various data sources as well as novel modelling approaches to allow continuous modelling of the benefit-risk along the lifecycle of products and its graphical representation for use by patients, healthcare prescribers, regulatory agencies, and drug manufacturers. •  Testing and validating various methods developed in PROTECT using a large variety of different sources in the EU (including disease registries) in order to identify and help resolve operational difficulties linked to multi-site investigations. •  Disseminating the methodologies developed in PROTECT. This will be enhanced by making use of existing and also developing new training and educational activities.