• Ref. Ares(2019)3933941 - 20/06l2019

HMA:Ill
EUROPEAN COMMISSION

DIRECTORATE GENERAL FOR HEALTHAND FOOD SACETY

Joint Letter by the European Commission, EMA and HMAJune 2019

LETTER TO STAKEHOLDERS REGARDING THE REQUIREMENTS TO PROVIDE RESULTS FOR
AUTHORISED CLINICAL TRIALS IN EUDRACTClinical trials are the key drivers of medical innovation and progress in patient-care and disease
prevention. A sufficient level of scrutiny and transparency in clinical trials is essential to protect
public health and to foster innovation in the medical research field. In order to achieve this, allrelevant protocol and results related information regarding clinical trials that are authorised in theEU needs to be kept in the EU Clinical Trials Database (EudraCT) and publicly available through the EU
Clinical Trials Register. This is particularly true for the timely publicatio,n of clinical trial resultsummaries, including information on the objectives, design and main conclusions and results of agiven study. Comprehensive access to summary results has been regarded an essential feature forclinical trials in order to allow patients, practitioners, policy makers and other economic operators tomake well-informed decisions about health-care and medical research.

The requirements for publishing clinical trial summary results in the EU Clinical Trials Database areincluded in the European Commission Guideline 2012/302 03/EC1. Accordingly, as of July 2014,
result-related information should be posted within one year (6 months for paediatric trials) after theend of a clinical trial2• The submission of the results to EudraCT is the direct responsibility of thesponsors. Once the sponsor submits the result in EudraCT, the information, with about 2-week delay,
is automatically fed into the European Union Clinical Trials Register and become available for publicscrutiny.

These provisions will remain applicable with a clear legal basis under the European Clinical Trials
Regulation (No 536/20143). The EU Portal and Database foreseen in this Regulation, as a single entry

1 Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) ofRegulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
2 Please note that although EudraCT contains results for phase I-IV trials, results for those Phase 1 trials, which are conducted solely inadults and are not part of an agreed PIP, will not become public in the EU Clinical Trials Register.
3 Regulation (EU)No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products forhuman use, and repealing Directive 2001/20/EC (OJXXXXXX)

point for the submission and maintenance of clinical trials by the sponsors, will be a key instrument
to realise this aim.

As of April 2019, there are 27,093 clinical trials completed out of 57,687 trials included in theEudraCT database, of which 18,432 should have results posted. This means that 68.2% (12,577) are incompliance with the publication rules whereas 31.8% (5,855) of the trials have missing results. This isan encouraging trend, though there is still significant progress to be made. In particular, thereporting compliance for non-commercial sponsors is much lower than for commercial sponsors(77.2% for commercial sponsors vs 23.6 % for non-commercial sponsors)4.

Underreporting in general and selective reporting of trials with positive outcome may lead topotentially avoidable redundancies in the conduct of clinical trials and compromise the economic andscientific efficiency of clinical research.

In addition, unreported clinical trials with unfavourable

outcome can have negative public health implications. Academic and other non-commercial sponsors
are particularly encouraged to post the results of their trials in EudraCT in order to maximise theirvaluable contribution to meet public health needs and to advance clinical research especially wherecommercial interest is weaker.

In order to improve compliance on the posting of results, the primary aim of this communication is toremind all sponsors about their obligation for the reporting of clinical trial summaries in the EU
Clinical Trials Database. In the spirit of the EU legislation, it is important that all stakeholders act
together to ensure compliance as soon as possible for the promotion of public health.

The following materials and tools are available for stakeholders in order to provide them withinformation and guidance on reporting trial results to EudraCT:•Results information documentation: httos://eudract.ema.europa.eu/result.html•EudraCT & EU-CTR Question and Answer table "Results" section (Q&A 34-62):
https://eudract.ema.europa.eu/docs/guidance/EudraCT%20FAO for%20oublication.pdf•Technical guideline on the format of the data fields of results-related information on clinical
trials:https:IIec.eu ropa. e u/hea lth/s ites/hea Ith /fi Ie s/fi Ies/ e udra Iex/vol-10/2013 01 22 tg en.pdf

Additional resources:•Multi-media tutorials: httos://eudract.ema.eurooa.eu/multimedia tutorials.html•Trainingmaterial(Q&Asfrom

previoustraining):

https://eudract.ema.europa.e u/tra ining.html•List of fields contained in EudraCT to be made public for paediatric and non-paediatric trials:
https:IIec. e u ropa .e u /hea!th/sites/he a lth/fi Ies/fi Ies/e u dr a !ex/vo I10/eudract nonpaediatric listoffields en.pdf (non-paediatric trials)

4 Please note that the data available in the EU Clinical Trials Register is a subset of the data from EudraCT.

https://ec. e u ropa .e u/he a I th/sites/he a It h/fi I es /fi I es/ eu d ra lex/vo 110/e u d ra ct paediatric listoffields en.pdf ( paediatric trials )We trust your commitment to ensure transparency and sufficient public scrutiny and thank you foryour efforts to report clinical trial results in a timely manner.
Signature:

Anne Bucher

Guido Rasi

Thomas Senderovitz

Director General

Executive Director

Chair of HMA Management GroupDG Health and Food Safety

European Medicines Agency

Heads of Medicines Agencies• Electronically signed on 20/06/2019 09:05 (UTC+02) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563