Clinical trials funded by the EDCTP 2014-2023
Dear Research Executive Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:
A list of all interventional clinical trials as defined by the World Health Organisation that were funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and whose funding period ended between January 2014 and December 2023, including the following data for each such trial:
(1) The EDCTP funding number for that trial
(2) The start and end dates of EDCTP funding for that trial (DD/MM/YYYY)
(3) The name of the company or institution that acted as the legal sponsor of the trial
(4) The trial registry number(s) of the trial (e.g. EudraCT, CTIS, NCT, ISRCTN, etc)
(5) The amount of funding provided by EDCTP coupled with a note on whether that sum was exclusively earmarked for the clinical trial, or for a broader project that included the clinical trial
(6) A hyperlink to the final published outcomes of the clinical trial, for example on a trial registry or in a peer reviewed journal
Please provide this information in Excel- or CSV-Format (not as PDF) in electronic form.
NOTE: The relevant World Health Organisation (WHO) definition is as follows:
“[A] clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.”
https://www.who.int/news-room/questions-...
If the categorisation of interventional medical studies underlying the data provided in response to this request differs from the WHO definition, for example because you internally use a different definition of ‘interventional clinical trial’, please additionally:
(7) Provide a copy of the definition that you used to identify relevant studies
BACKGROUND: EDCTP signed up to the WHO Joint Statement in 2017: “agree to monitor registration and endorse the development of systems to monitor results reporting on an ongoing basis”
https://www.who.int/news/item/18-05-2017...
https://www.ncbi.nlm.nih.gov/pmc/article...
The data provided in response to this request will form the basis of an academic study on clinical trial registration and reporting, covering research funding bodies in multiple jurisdictions.
Thank you for your time, best wishes,
Till Bruckner
Dear Sir or Madam,
We are writing to you concerning your request for access to documents sent
on 04/06/2024 and registered on 04/06/2024 under case number 2024/2940.
Since you have not indicated your postal address, we are not able to start
handling your request. The 15 working days to reply to your request will
start running only when you send us your postal address.
You can send your postal address by replying to this e-mail. If we do not
receive your reply we may close this case.
Please note that you can submit a request for access to Commission
documents via the portal [1]'Request a Commission document', which does
not require you to indicate your postal address.
Why do we need your personal postal address?
Since 1 April 2014, the submission of a postal address became a mandatory
feature when submitting an application for access to Commission documents
via an e-mail. We would like to explain why we need your postal address in
order to register and handle your application for access to documents when
submitted via e-mail:
• Firstly, to obtain legal certainty as regards the date you received
the European Commission reply to your application for public access to
documents. Article 297 of the Treaty on the Functioning of the
European Union (TFEU) states that 'decisions which specify to whom
they are addressed, shall be notified to those to whom they are
addressed and shall take effect upon such notification.' In line with
this provision, if the Commission does not grant full access to the
requested documents, it notifies the reply to the applicant via
registered mail with acknowledgement of receipt or via delivery
service. This requires an indication of a valid postal address by the
applicant;
• Secondly, to apply correctly the [2]Data Protection Regulation (EU)
2018/1725. Knowing whether the applicant is an EU resident (or not) is
necessary for deciding which conditions shall apply for the
transmissions of personal data to applicants for access to documents.
These conditions are not the same for recipients established in the
Union and for recipients in third countries. As the vast majority of
the documents requested contain personal data, the Commission cannot
ensure the correct application of the data protection rules in the
absence of a postal address;
• Thirdly, to apply correctly [3]Regulation (EC) No 1049/2001. Article
4(1)(b) of that Regulation refers to the protection of the privacy and
integrity of the individual and has to be applied in line with the
Data Protection Regulation;
• Fourthly, to protect the interest of other citizens and safeguard the
principle of good administration. The Commission has to treat all
citizens equally by ensuring that the legal framework for public
access to documents is respected. For example, it has to verify
whether Article 6(3) of Regulation (EC) No 1049/2001 is being evaded
by introducing several requests under different identities. Indeed, in
its Ryanair judgment ([4]EU:T:2010:511), the General Court confirmed
that Article 6(3) of Regulation (EC) No 1049/2001 cannot be evaded by
splitting an application into several, seemingly separate, parts. In
addition, the Commission has to make sure that the legal framework is
respected and the right of access to documents is not abused by making
requests under an invented identity.
The considerations above show that the request for and the consequent
processing of the applicant's postal address is not only appropriate, but
also strictly necessary for the performance of a task carried out in the
public interest within the meaning of Article 5(1)(a) of Data Protection
Regulation, namely providing a smooth and effective access to documents.
Yours faithfully,
Secretariat-General - Access to Documents
European Commission
References
Visible links
1. https://www.ec.europa.eu/transparency/do...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...
4. https://eur-lex.europa.eu/legal-content/...
Dear Research Executive Agency,
My postal address is as follows:
Till Bruckner
Am Buechel 53b
53173 Bonn
Germany
Please initiate the search for documents / data.
Yours faithfully,
Till Bruckner
Dear Mr Bruckner,
Your request for access to documents was yesterday forwarded to the European Commission. The documents related to your request are not under the competences of REA.
Please reply to the request for postal address as indicated by the European Commission.
Kind regards,
REA Access to Documents.
Dear Sir,
We are writing concerning your application for access to documents
received by DG Research and Innovation on 5 June and relating to clinical
trials funded by the European and Developing Countries Clinical Trials
Partnership Association (EDCTP).
Given the subject of your application, it is not the Commission the
institution responsible for handling it, but the EDCTP Association itself,
which is a separate organisation.
Should you wish so, you may submit your request directly to them at
[1][email address] and [2][email address].
We remain of course at your disposal should you have any question or
request to address to us.
Kind Regards,
RTD Access to Documents
References
Visible links
1. mailto:[email address]
2. mailto:[email address]