Transparency Policies in the EU from Clinical Trials to Pharmacovigilance

Margarida Menezes Ferreira22 anos de serviço público com valores e ética

Margarida Menezes Ferreira

Ilona Reischl

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 2014Application information and Clinical trial summary reports

• EU portal and database – starting from 2018• Application information• Recruitment status• Dossier• Clinical trial summary report

EU Clinical Trials Register

4

Examplehttps://www.clinicaltrialsregister.eu

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

Result related information

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 ContentsTrial 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

Subject disposition- Recruitment - Pre-assignment Period - Post-Assignment Periods

Baseline Characteristics- Age - Gender - Study Specific

End Points- Endpoint definitions

-- End Point #1 --- Statistical Analyses

-- End Point #2, --- Statistical Analyses

…

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

https://eudract.ema.europa.eu/document.html „Result related documentation“ & „Training on EudraCT results“

Procedural aspects• The posted result-related information is made public through the

EU Clinical Trials Register (only result-related information on non-paediatric 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 post-

authorisation safety of medicines through safety reports

THANK YOU!

This presentation has been a joint development by Portugal and Austria

Thank you for your attention!

Foto: MMF

Foto: IGR