clinical trials

[EPT] Clinical Trials – new Regulation - Proposal for the Clinical Trials Regulation (CTD) - (updated on 30 April 2013)

Clinical trials Clinical trials are “Investigations in humans intended to discover or verify the effects of one or more investigational medicinal products (IMPs)”. Trials conducted in the European Union (EU) are currently governed by Directive 2001/20/EC (the Clinical Trials Directive, CTD) but these guidelines have been implemented differently across member states, thereby failing to reduce red tape and increasing costs. Consequently, in July 2012, the Commission published its (...)

Public consultation on Declaration of Helsinki on medical research involving human subjects

A two-month public consultation (15 April to 15 June 2013) on the World Medical Association’s Declaration of Helsinki on medical research involving human subjects has been launched by the World Medical Association. A revised version of the Declaration is available on the WMA website. This consultation is of particular interest in the context of the ongoing revision of the Clinical Trials legislation. Please click here for detailed information on the consultation process The (...)

Clinical trials: Exploring the limits of transparency

Glenis Willmott MEP (S&D, UK) took the initiative to bring together experts to discuss the extent to which more transparency could be workable in non-commercial clinical trials. The debate, which took place in the European Parliament on 10 April, served to present the key arguments for and against increased transparency in the context of administrative and data reporting requirements for academic researchers and patient safety. EPHA’s Position on Clinical Trials urges political (...)

[Special Summary] EU General Data Protection Regulation and Health Research

On 17 December 2012, the European Parliament’s Committee on Civil Liberties, Justice and Home Affairs (LIBE) released its draft report on the European Commission’s proposal for a regulation on the processing and free movement of personal data. The proposal and the amendments offered in the draft report have implications for a number of elements of health, inlcuding health research. This article takes a closer look at the potential effects of the new legislation for research (...)

Ireland’s Presidency Health Priorities presented

Ireland, in collaboration with its TRIO partners - Lithuania and Greece - has made a commitment to use its resources to prioritise solid progress on a number of key legislative dossiers in health and calls on member states to work together, sharing ideas, information and best practice. The Irish Presidency Programme, whose cornerstone is progressing the legislative agenda, contains a series of health priorities: on 23 January 2013 the Irish Minister of Health, James Reilly, presented them (...)

Roundtable on Clinical Trials

Hosted by the European Policy Centre (EPC), this EPC’s Coalition for Health, Ethics and Society (CHES) roundtable on the revision of the Clinical Trials legislation provided an opportunity for EPHA to present its Position on the policy dossier and exchange views with stakeholders including representatives of the European Commission, industry and an NGO representing older people. The roundtable was kicked off by Stefano Soro, Head of unit for Medicinal Products – quality, safety (...)

Revised EPHA position on clinical trials

EPHA has revised its position on clinical trials following the European Commission’s release of a legislative proposal for a regulation over the summer. While the key elements remain the same, the updated version emphasises the need for clinical trials to go ahead so that different population groups can benefit from life-saving treatments, while underlining that patient safety must remain at the centre of the process, and not compromised by less rigid assessment procedures. The (...)

Clinical Trials Directive: transparency in medical research to protect public health

On Tuesday 13 November 2012, EPHA attended the event ’Transparency in medical research to protect public health: Opening up EU clinical trial data for safe and effective medicines’. Organised with support from EPHA member, Health Action International (HAI), and the Transatlantic Consumer Dialogue (TACD), the event brought academics, experts, policy-makers, regulators and the European Commission together to discuss the clinical trials regulation. More specifically, participants (...)

European Voice Event - "Righting Wrongs: will clinical trials get a new deal in Europe?"

Clinical Trials: European Commission revamps the EU rules

The European Commission has published its draft proposal to revise the Clinical Trial Directive. According to the European Commission, the main aim of the revised proposal is to simplify the rules for conducting clinical trials in Europe, while maintaining the highest standards of patient safety. Once adopted, the proposed Regulation will replace the 2001 ’Clinical Trials Directive’. The objective is to ensure that Clinical Trials rules are identical throughout the EU. The (...)