Transparency of clinical trials data

This document contains an overview of current rules on access to clinical trials data, an overview of the anticipated legislative changes and a summary of the issues that the new regulation may bring, including concerns raised by the industry. This is an area of considerable interest to the industry at large and to many clients, and is one that Allen & Overy is following in detail.

Information on clinical trials is accessible to the public through the EU Clinical Trials Register website, launched by the European Medicines Agency (EMA). The register provides public access to the following information: interventional adult clinical trials for medicines, phase II to phase IV, which were authorised in the EU member states or the EEA; and clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.

Specifically, the register contains information on trial identification, identification of the sponsor, information on each investigational medicinal product, information on placebo, objective, scope, trial type and phase and design of the trial. The information available dates back to 2004…

If you are registered and logged in to the site, click on the link below to read the rest of the Allen & Overy briefing. If not, please register or sign in with your details below.

Analysis from The Lawyer

  • Panel reviews

    Panel reviews 2014: The chosen ones

    Which firms are cutting it in this era of slimline rosters, and who are the GC new brooms making clean sweeps? The Lawyer can reveal all

  • training

    Accutrainee: Revolution postponed

    At the time of its launch Accutrainee was described as a revolutionary change to the training model. Has it proved to be so? Not really.

View more analysis from The Lawyer


One Bishops Square
E1 6AD

Turnover (£m): 1,189.00
No. of lawyers: 2,304
Jurisdiction: UK
No. of offices: 11
No. of qualified lawyers: 273