Transparency Policies in the EU from Clinical Trials to Pharmacovigilance Margarida Menezes Ferreira Ilona Reischl 22 anos de serviço público com valores e ética Margarida Menezes Ferreira
Content Transparency During the clinical trial stage At Marketing Authorization After licensure - Pharmacovigilance
Transparency during the Clinical Trial stage Progressive increase of transparency EU register since 2010 Selected information from (EudraCT) application file EU register since 2014 Application information and Clinical trial summary reports EU portal and database starting from 2018 Application information Recruitment status Dossier Clinical trial summary report
Example https://www.clinicaltrialsregister.eu EU Clinical Trials Register 4
Result related information Publication of results As of 21 July 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA). Since the result-related information is fed into the publicly accessible European Union Clinical Trials Register, summary results of clinical trials will become available to the public as sponsors start to comply with their legal obligations. 5
Results upload in EU Register replaces submission to the NCA (4.3 CT-1) replaces submission to the Ethics committee (4.2.1 CT-1) (for published information) Publication criteria: Result-related information on non-paediatric Phase-I clinical trials is not made public! Only non-paediatric Phase I trials still have to report to the Ethics committee. 6
Full-Data-Set Contents https://eudract.ema.europa.eu/document.html Result related documentation & Training on EudraCT results Trial information - Study identification - Identifiers - Sponsor details - Paediatric regulatory details - Result analysis stage - General Information about the trial - Population of trial subjects with actual number of subjects included in the trial - Recruitment - Pre-assignment Period - Post-Assignment Periods - Age - Gender - Study Specific Subject disposition Baseline Characteristics - Endpoint definitions -- End Point #1 --- Statistical Analyses -- End Point #2, --- Statistical Analyses End Points Adverse Events - Adverse events information - Adverse event reporting group - Serious Adverse Events - Non-serious adverse event More Information - Global Substantial Amendments - Global Interruptions and re-starts - Limitations & Caveats 7
Procedural aspects The posted result-related information is made public through the EU Clinical Trials Register (only result-related information on nonpaediatric Phase-I clinical trials is not made public.) The result-related information is made public within 15 working days from the posting of a valid data set. In addition to being readable in situ on the web, the data will also be made available in a printable format and in a downloadable format. The web interface is going to provide tools to facilitate the searching, reading and browsing of the public information on clinical trials and their results. 8
Transparency at Marketing Authorization Final policy on publication of clinical data Oct. 2014 European Medicines Agency policy on publication of clinical data for medicinal products for human use Q&A on the European Medicines Agency policy on publication of clinical data for medicinal products for human use.. applies to clinical reports contained in all initial MAAs and variations for extension of indication/line extension. Reports to be published 60 days after a decision (first reports foreseen mid-september 2016) www.ema.europa.eu Home Human regulatory Clinical data publication
Transparency at Marketing Authorization General information Procedural aspects related to submission of clinical reports (CR) for the purpose of publication Anonymisation of CRs for the purpose of publication Applying these general considerations EMA recommendations how best to achieve anonymisation Redaction of personal data of investigators, sponsor staff and applicant/mah staff Identification/ redaction of commercially confidential information Annexes
Obinituzimab - QbD
After Licensure - Pharmacovigilance
Databases with public aspects EU Clinical Trials Register: database containing registrations of clinical trials EudraGMDP: overview of the status of pharmaceutical manufacturers EudraPharm: database of authorised medicinal products EudraVigilance: a system monitoring the postauthorisation safety of medicines through safety reports
THANK YOU! This presentation has been a joint development by Portugal and Austria Foto: MMF Thank you for your attention! Foto: IGR