The European Medinicnes Agency (EMA) evaluates regulatory impact of PROTECT
The EMA has reviewed the key outputs of PROTECT to evaluate how they have been or will be implemented into regulatory practice. This review concludes that PROTECT has achieved the objectives and deliverables of the Call Topic to which the PROTECT consortium applied. In addition, outcomes linked to signal detection and evaluation are being implemented into routine pharmacovigilance and regulatory practice and start to have a positive impact on public health and resources. In the course of this evaluation, a survey tool to measure the public health impact and feasibility of research projects has been developed and piloted. The report is available here.
PROTECT WP2 new publications added
Two new publications from WP2 are now available throught the PROTECT website, namely:
Afonso A. et al: "A methodological comparison of two European primary care databases and replication in a US claims database: inhaled long-acting beta-2-agonists and the risk of acute myocardial infarction" (WP2 WG1) and Schmield S. et al: "Response to Wise et al. (Tiotropium safety in real life populations)" (WP2 WG3).
PROTECT WP2 on PDS Special issue
The Pharmacoepidemiology and Drug Safety journal has published a Special Issue on the IMI-PROTECT WP2. The European Medicines Agency has announced it on its website with links to the main publications and a summary of the main results. You can find all the information here.
ADR Database - Update now available
The PROTECT ADR database has been updated up to 31 December 2013. The database lists all adverse drug reactions (ADRs) listed in section 4.8 of the Summary of Product Characteristics (SPC) of medicinal products authorised in the EU according to the centralised procedure.
PROTECT at ICPE 2015
PROTECT was part of the 2015's International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in Boston with a specific Symposium titled: "PROTECT: The Challenges and Successes". Participants to the Symposium were informed about the most important results of WP2, WP3, WP4 and WP5 and how they may impact pharmacovigilance practice from industry and regulatory perspectives. The difficulties met to recruit directly pregnant women, and the solutions adopted by WP4, were discussed. A framework for evaluating the potential impact of regulatory science projects and the results of a test on PROTECT outputs were presented. Slides presentations and a poster are available here.
PROTECT WP4 Report
The Final report of WP4, New methods for data collection from consumers is now available on the PROTECT website. In the report, the PROTECT Pregnancy Study team shows that collecting data directly from consumers, such as pregnant women, for pharmacovigilance is feasible and valuable, but not without difficulties.
The report can be accessed through this link.
PROTECT Symposium - materials available in the PROTECT website
Following the PROTECT Symposium organised on the 18-19-20 February 2015 at the Europena Medicines Agency in London, videos and presentations from the event are now available in a dedicated section of the PROTECT website.
Adverse Drug Reactions Reference Dataset
The ADRs Reference Dataset used by Work package 3 (WG1 and WG8) is now available in our "Results" section at the specific link to Methods for Signal Detection Reports and Databases .
PROTECT Symposium 18-20 February 2015
The IMI PROTECT project will terminate on 28 February 2015 and on this occasion, the European Mediciens Agency will organise a Final Symposium titled “Monitoring benefits and risks of medicines: PROTECT results and recommendations” on the 19th and 20th February 2015. The symposium will be preceded by parallel training sessions on 18 February to explain some technical topics more in-depth.
If you wish to attend the Symposium, you can express your interest until the 28th of November 2014 by filling the registration form which is accessible through the link included in the on line invitation.
Given the limited number of places, we invite you to register at your earliest convenience.
The Symposium will be recorded and the videos and slide presentations will be made available on the EMA website.
For more information, please contact: ProtectSymposium@ema.europa.eu
PROTECT at ICPE 2014 - updates
PROTECT will present 13 posters, 8 oral presentations and 2 Symposiums at the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), which will be held in Taipei (Taiwan, 24th - 27th October 2014).
New Publications for the PROTECT project
PROTECT has published two new articles respectively within the work programme on the Framework for pharmacoepidemiology studies (WP2) and the work programme on Benefit-Risk integration and representation (WP5).
You can find them in our Results section.
PROTECT 4th Periodic Project Report.
The fourth PROTECT project periodic report covering the period 1 September 2012 to 31 August 2013 and endorsed by the Innovative Medicines Initiative last December 2013, is now available. Please find the report here: PROTECT 4th Periodic Report_Sep 2012-Aug 2013.
PROTECT at ICPE 2014
PROTECT has submitted 26 abstracts to the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), which will be held in Taipei (Taiwan) from 24th to 27th October 2014.
- “Scientific Validation in an Era of Rapid Decision Cycles: Differing Views on the Implementation of Results from Regulatory Science”
- “Impact of methodological choices on findings from pharmacoepidemiological studies: final results of the IMI-PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project”.
PROTECT WP2/WG3 has published the updated version of the Drug Consumption Databases.
The authors have reviewed, compiled, and updated the knowledge about European sources of data on drug utilisation in the out- and inpatient healthcare setting. Information is available for Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Slovenia, Spain, Sweden, The Netherlands, and The United Kingdom. Information was last updated December 2013.
Two documents are available. A master document organised as a scientific article, with a detailed and accurate account of the information already available, methods to retrieve this information, and a discussion. And, a country profile document with a summary of the relevant information from the masters document: country’s health system, reimbursement characteristics, and a list of websites of interest, summarised by country.
These documents are a shared resource for researchers, regulatory agencies, and pharmaceutical companies.
PROTECT WP 3.7 has published two studies on the masking effect of measures of disproportionality analyses.
The authors of these studies have developed and validated a mathematical algorithm aimed at identifying the presence, direction and magnitude of a masking effect associated with the use of quantitative methods based on disproportionality analysis (ROR, PRR and RRR). This algorithm has been used on two spontaneous reporting databases (EudraVigilance and Pfizer databases). The study suggests that important masking associated with a single (highest) masking product might be rare, is induced by products for which the reaction is known or has been extensively or over reported. The masking mainly affects events rarely reported in the database. These two studies have been published in Pharmacoepidemiology and Drug Safety. They can be found here
PROTECT publishes the final recommendations Report from WP5 on the IMI-PROTECT Benefit Risk.
PROTECT publishes presentations and posters from the 29th ICPE Meeting.
Presentations and posters from the 29th ICPE Meeting held in Montreal on the 25-28 August 2013 are now on line on THE PROTECT website.
PROTECT publishes reviews of benefit - risk methods and results of real-life case studies
PROTECT has published reviews of available methodologies for the assessment, integration and visualisation of the benefit-risk of medicines, as well as recommendations on methods of graphical expression for use by patients, healthcare providers, the pharmaceutical industry and regulators. Results of real-life case studies comparing methods with different levels of complexity are also posted. These case studies were conducted in two waves and concern the following medicines: efalizumab, natalizumab, rimonabant, rosiglitazone, telithromycin and warfarin.
The reports are available here.
PROTECT at 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (25-28 Aug 2013, Montreal)
Twenty-nine (29) abstracts have been accepted for ICPE 2013. This include the Symposium “De Groot M et al, Improving consistency in findings from pharmacoepidemiological studies: the IMI-PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project”.
The following abstracts have been accepted for oral or poster presentations:
Framework for pharmacoepidemiology studies
Work Package 2
- Abbing-Karahagopian V, Antidepressant prescribing in five European countries: application of common definitions to assess exposure prevalence - poster
- Afonso A et al, Comparison of six electronic healthcare databases in Europe using standardized protocols: a descriptive study on the incidence of cancer - poster
- Ali M.S. et al., Quantitative Verification of Instrumental Variables Assumption Using Balance Measures - poster
- Ali M.S. et al, Assessment of balance in propensity score analysis in the medical literature: a systematic review - poster
- Ballarin et al, Epidemiologic Measures of Drug use: Antiepileptic drugs, benzodiazepines, and antidepressants in four European countries - poster
- Brauer R et al, Prevalence of antibiotic use: A methodological comparison across various European health care data sources - poster
- De Groot M et al, Antiepileptic drug use in seven electronic health record databases in Europe: A methodological comparison - poster
- De Groot M et al, Comparison of seven electronic healthcare databases in EU countries using a standardized methodology; a descriptive study on the exposure to calcium-channel blockers (CCBs) - poster
- Ferrer et al, Antiepileptic drugs and suicide: a systematic review - poster
- Groenwold RHH et al, Impact of censoring on estimates of adverse drug effects: a simulation study - poster
- Huerta C et al, Prevalence of use of benzodiazepines and related drugs in seven European databases: A cross-national descriptive study from the PROTECT-EU Project - poster
- Rañopa M et al, Conflicting Results among Observational Studies Investigating Statin Use and Cancer risk: a Systematic Review - poster
- Rañopa M et al,, The Identification of Incident Cancers in UK Primary Care Databases: A Systematic Review - poster
- Requena G et al, Trends in incidence rates (IR) of hip/femur fractures in 5 European countries: a comparison using electronic health care records (e-HCR) - poster
- Rottenkolber M et al, Prevalence of inhaled long-acting beta-2-adrenoceptor–a comparison of seven European databases - poster
- Rottenkolber M et al, Association between bronchodilator treatment and myocardial infarction in COPD patients: a structured assessment of systematic reviews and meta-analyses - poster
- Sabate et al, Assessing quality in systematic reviews of adverse effects - poster
- Sanni M et al, Balance Measures for Determining Optimal Caliper Width in Propensity Score Matching: a simulation study - poster
- Uddin M J et al, Application of Instrumental Variables Analysis in Pharmacoepidemiology: an Example of Beta2-Agonist Use and Myocardial Infarction - slide presentation
Methods for Signal Detection
Work Package 3
- Edwards IR et al, Risk identification in Healthcare Records: comparison to epidemiological studies - poster
- Slattery J et al, A comparative evaluation of disproportionality measures in EudraVigilance – striking variability with time on market
- Tregunno P et al, Hit-miss model detects duplicates missed by rule-based screening of individual case safety reports - poster
Benefit- Risk integration and representation
Work Package 5
- van den Ham H.A. et al, Balancing individual benefits and risks of warfarin in patients with atrial fibrillation - poster
Work Package 6
- Astrup A et al, Impact of censoring at or truncating risk time of hospitalizations on the effect measure of the association between antiepileptic drugs (AED) and suicide attempt - poster
- Gasse Ch et al, Impact of previous suicide attempts and family history of psychiatric disease on the size of the association between antiepileptic drugs and suicide related events - poster
- Grimaldi - Bensouda L et, Risk of suicide attempts associated with antiepileptic drugs: a case-control study looking at the effect of differing design options - poster
- Tcherny - Lessenot et al, Replication study on the risk of liver injury associated with the use of antibiotics using a US database with linkage with hospital data- poster and presentation
- Udo R et al, Validation of hospital discharge diagnoses and liver related laboratory measurements to identify patients with idiopathic acute liver injury- poster
PROTECT at ISPE Mid Year meeting in Munich
The following presentations were presented at Mid-Year ISPE meeting in Munich on 11-12 April 2013:
- S Blackburn, Why is PROTECT so important to EMA and drug safety in Europe;
- D Ashby, Future directions of benefit-risk assessment in Europe;
- Ibanez L, Access to reliable Drug Consumption data;
- Schlienger R, de Groot M, Comparative analyses of Drug Adverse Event Associations in Various European Databases;
- Groenwold R, Propensity scores and instrumental variables;
The presentations are now available on PROTECT website in the General Presentations section.
Results of PROTECT WP5 presented at Drug Information Association (DIA) conferences
Results of PROTECT WP5 (Benefit-risk assessment integration and representation) will be presented at Euro DIA (4-6 March) by Dr Christine Hallgreen, at China DIA (13-15 May) by Dr. Juhaeri Juhaeri and at US DIA (25 June) by Dr. Diana Hughes.
The presentations will include results of a systematic review of BR assessment methodologies from the literature and their classification to distinguish their roles and to aid methods selection; the review on visualisation techniques to represent the results from BR analyses; and the illustration of recommended methodologies with case-studies on medicines where benefit-risk is finely balanced, including treatments for relapsing-remitting multiple sclerosis, psoriasis, obesity, respiratory tract infections, diabetes and prevention of thromboembolic stroke.
PROTECT at ICPE 2013
PROTECT has submitted 31 abstracts for scientific communications at the 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in Montreal (25-28 August 2013). These abstracts originate from WP2, WP3 and WP6 and include a proposal for a full symposium titled “Improving consistency in findings from pharmacoepidemiological studies: the IMI-PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium) project”.
Collider-stratification and confounding bias due to conditioning or stratifying on time-dependent propensity scores (PS) were explored using a clinical example on the effect of inhaled short- and long-acting beta2-agonist use on coronary heart disease. The study was conducted in a cohort of patients in an electronic general practice database in The Netherlands. Results were similar for different PS methods,
but higher than those of Marginal Structural Models (MSMs). When treatment and confounders vary during follow-up, conditioning or stratification on time-dependent PS could induce substantial collider stratification or confounding bias; hence, other methods such as MSMs are recommended.
See more PROTECT Publications
ADR Database - Update now available
The PROTECT ADR database has been updated up to 30 June 2012. The database lists all adverse drug reactions (ADRs) listed in section 4.8 of the Summary of Product Characteristics (SPC) of medicinal products authorised in the EU according to the centralised procedure.
Drug Consumption Databases in Europe: Update now available
The PROTECT inventory is a comprehensive and structured source of information on drug consumption in Europe. It comprises two documents. The master document contains a detailed report of the information already available, methods to retrieve this information, and a discussion. The country profile document summarizes the main results by country.
IMI JU has approved 3rd project report
The third PROTECT project periodic report covering the period 1 September 2011 to 31 August 2012 has been endorsed by the Innovative Medicines Initiative. A summary of the project’s progress made during this period is available on the PROTECT website.
For more information see:
PROTECT WP4 Pregnancy Studies
Are you pregnant, living in the UK, The Netherlands, Denmark or Poland ?
Do you want to improve medical understanding for future generations?
If so you may want to take part in a European wide pregnancy study, called PROTECT pregnancy study.
You can look at the information about our study and how you can join on our dedicated website.
For more information see : www.pregnancystudy4.eu
The PROTECT Conference took place on 22-24 October 2012 in Copenhagen and it was hosted by the Danish Health and Medicines Authority. The three-day meeting consisted in the PROTECT Consortium Assembly on the first day and Work Packages meetings on a second and third day.
Submitted PROTECT abstracts for ICPE 2012
- Abbing et al, Timing of Concomitant Drug Use in Pharmacoepidemiological Studies
- Ballarin et al, A proposed checklist to interpret cross-national comparison studies of drug utilization
- Ferrer et al, Inpatient drug consumption in Europe (PROTECT project)
- Grimaldi Bensouda et al, PROTECT Work Package 6 Project synthesis
- Hesse et al, Calcium Channel Blocker (CCB) Treatments and Cancer Risk. Linking Danish National Health Care databases
- Hill et al, Grouping related medical terms may not expedite detection of disproportional reporting patterns in pharmacovigilance
- Klungel et al, Explaining differences in drug-adverse event associations across and within EU databases. The PROTECT project
- Klungel et al, Transparent, Reproducible and Reusable Research in Pharmacoepidemiology
- Sanni et al, Evaluating propensity score balance measures in typical pharmacoepidemiological settings
- Sanni et al, Time-dependent Propensity Score and Collider-Stratification Bias: an example of beta2-agonist use and risk of myocardial infarction
- Sabate et al, Antibiotic consumption in 8 European countries analyses from data provided by IMS Health
- Tjeerd van Staa et al, Harm-benefit modelling
- Uddin et al, Performance of Instrumental Variable Methods in Case-Control and Cohort Studies A Simulation Study
- Van Den Ham et al, The patterns of anticoagulation control and the risk of stroke, bleeding and mortality in patients with non-valvular atrial fibrillation
- Wisniewski et al, Characterisation of databases (DBs) used for signal detection (SD): results of a survey of IMI PROTECT work package (WP) 3 participants
|26-27 April 2012||
PROTECT Joint External Advisory Board & Steering Committee Meeting
The 2012 Joint External Advisory Board & Steering Committee meeting will take place on 26-27 April at EMA. Each Work Package will have the opportunity to discuss their results, study protocols and work plan with external experts who will provide advice and recommendations.
For more infomation see: Governance Structure
26 March 2012
PROTECT Conference 2012
A PROTECT Conference will take place on 22-23 October 2012 in Copenhagen and will be hosted by the Danish Health and Medicines Authority. The two-day meeting will consist in the PROTECT Consortium Assembly on the first day and Work Packages meetings on a second day.
For more information see: Danish Health and Medicines Authority
12 March 2012
PROTECT IMI Review
The PROTECT co-leaders participated to a mid-term Expert review of the project organised by IMI in Brussels. The objectives of the meeting were to critically review the progress of the PROTECT project and make recommendations for improvements. Generally, PROTECT was congratulated for the quality of the work, the progress of the project and the enthusiasm and commitment of its participants. The project is seen as a strong and long-standing support for developments in pharmacovigilance and pharmacoepidemiology.
PROTECT at ISPE 2012
The 28th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) sponsored by the International Society for Pharmacoepidemiology (ISPE), the International Society for Pharmacovigilance (ISoP) and the European Association for Clinical Pharmacology and Therapeutics (EACPT) will be held in Barcelona in August.
This event will provide an unbiased scientific forum to the views of all parties with interests in drug development, drug delivery, drug use, drug costs, and drug effects.
Several researchers from PROTECT have already sent their abstracts for evaluation. It is therefore expected that, once more, ICPE will be an ideal forum for PROTECT to present its latest results, and many PROTECT partners will be attendanding it.
Submitted PROTECT abstracts for ISPE 2012
- Abbing et al, Timing Concomitant Drug Use, Feb 2012
- Ballarin et al, DU validity, Feb 2012
- Ferre et al, Hospital DU, Feb 2012
- Grimaldi Bensouda et al, PROTECT Work Package 6 Project synthesis, Feb 2012
- Hesse et al, CCB treatment and Cancer risk. Linking Danish National Health Care databases, Feb 2012
- Hill et al, Grouping related medical terms may not expedite detection of disproportional reporting patterns in pharmacovigilance, Feb 2012
- Juhaeri et al, Benefit Risk Analysis - Present and Future, Feb 2012
- Sanni et al, PS Balance Measures, Feb 2012
- Sanni et al, Time-Dependant PS and Collider Stratification Bias, Feb 2012
- Sabate et al, Antibiotic consumption in 8 European countries analyses from data provided by IMS Health, Feb 2012
- Uddin et al, Performance of Instrumental Variable Methods in Case-Control and Cohort Studies A Simulation Study, Feb 2012
- Wisniewski et al, Characterisation of databases used for signal detection, Feb 2012
6 September 2011
PROTECT - NEW journal publications
PROTECT Work Package 2 (Framework for pharmacoepidemiology studies) publishes first results on balancing confounders using propensity score methods and selection of confounding variables for adjustment.
For more information see: PROTECT Publications
|6 September 2011||
PROTECT at ICPE - abstracts now available online
Several PROTECT researchers presented their results at the 27th International Conference on Pharmacoepidemiology & Therapeutic Risk Management which took place in August in Chicago. The abstracts have been published in Pharmacoepidemiology & Drug Safety.
For more information see:
|23 May 2011||
IMI Stakeholders Forum 2011
For more information see: IMI Stakeholders Forum 2011
|23 May 2011||
IMI JU has approved 1st Project
For more information see: Summary of First Periodic Report
|12 May 2011||
PROTECT External Advisory Board Meeting
The third joint meeting of the PROTECT External Advisory
Board and the Steering Committee took place in February 2011. The External
Advisory Board reviewed the progress made so far by the individual work packages
and provided recommendations for the implementation of the research agenda. It
was concluded that the achievements of the project to date were remarkable and
the consortium has met the challenge of the project’s considerable scope. The
Board also praised the fact that already a number of publications and
presentations have emerged or are under preparation. The next joint meeting is
scheduled to take place during the first half of 2012.
|16 March 2011||
Summary of Periodic Report No. 1
The summary of the first Periodic Report is now available online. The report addresses the achievements of the 1st project year, starting on 1 September 2009 and ending on 31 August 2010. The report is a joint effort of the PROTECT Consortium and reflects the progress and main results achieved by the project so far.
For more information see: Summary of First Periodic Report
|18 January 2011||
New PROTECT Partners
Two new partners have recently joined the PROTECT Consortium. Poznan University of Medical Sciences, a leading Polish medical centre, will mainly contribute to Work Package 4. The second new partner is Takeda Global Research and Development (Europe) Ltd, a research-based global company headquartered in Japan. Takeda will be represented in Work Packages 3 and 5.
|15 October 2010||
PROTECT Consortium Assembly
The 2010 Consortium Assembly took place on 14 October 2010 at the premises of the European Medicines Agency in London. The Assembly reviewed the progress and costs of the project during the first year. An operational and managerial framework as well as the budget for the forthcoming project year were adopted. The final report will be sent to the IMI-JU project office within the next days.
|31 August 2010||
End of Project Year 1
31 August 2010 marks the end of the first out of five project years for PROTECT. The progress report is currently under preparation, a summary of which will be made publicly available once it has been approved by the Innovative Medicines Initiative (IMI).
|14-15 June 2010||
IMI Stakeholder Forum
The Innovative Medicines Initiative welcomed industry representatives, regulators, policy makers, scientific experts, patient representatives and science leaders at its first Stakeholder Forum in Brussels. The event featured presentations and discussions about the ongoing IMI projects, the IMI research agenda, the 3rd Call (2010) research topics and the IMI intellectual property policy.
For more information Click here
|30 March 2010||
PROTECT has signed IMI Grant AgreementAll PROTECT Consortium Partners have successfully acceded to the Grant Agreement which was signed in February between the IMI Joint Undertaking, the European Medicines Agency (PROTECT Project Coordinator) and the Danish Medicines Agency (Managing Entity of PROTECT).
|18 May 2009||The Innovative Medicines Initiative (IMI) has announced the names of 15 new research projects, aimed at bringing innovative medicines more quickly to the market, that have been selected to receive €246 million from the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).|
|15 May 2009||The first PROTECT Consortium Assembly took place
at the offices of the European Medicines Agency (EMEA) in London on 15 May 2009,
in preparation for the official start of the project on 1 September 2009.
For photos Click here
|29 April 2009||EMEA-coordinated PROTECT project has been
accepted for funding by the Innovative Medicines Initiative Joint Undertaking
For the press release Click here