Introduction

A clinical trial is a research study conducted in human participants to evaluate the safety and efficacy of a medicine expected to improve patients health. Clinical trials can only be started after a compound has survived rigorous pre-clinical development work, which involves laboratory testing (chemical/biological/pharmacological/toxicological). It is only when these tests show favourable and promising results that a company can proceed to assess the medicine in humans.

Clinical trials are the link between the results of pre-clinical testing and actual medical practice. They allow researchers to demonstrate the efficacy and safety of a new medicine or treatment, which is a prerequisite for marketing authorization. Without clinical trials a medicine could not be made available for treating patients. It is only through clinical trials that progress will be made on new medicines and improved treatment for diseases.

Clinical Trials represent on average 58,6% of a product total development costs. The current Clinical Trials Directive 2001/20/EC introduced a first level of harmonisation among Member States’ procedures for Clinical Trials Approval. It carried provisions notably on protection of health and safety of clinical trials’ participants which represent value for the Community. However, a substantial lack of homogeneity subsists in terms of administrative requirements, which leads to delaying the conduct of clinical trials and increased costs. Clinical trials are an essential part of the medical research as they aim at providing the community with the latest innovative treatments and state-of-the-art clinicalpractice while fuelling innovative thinking in the clinical scientists’ teams for the benefit of European Patients.

EFPIA welcomes the Commission’s proposal for revised clinical trial legislation in the interest of maintaining the EU’s competitiveness in clinical research. EFPIA acknowledges that the Commission has tried to address concerns and proposals from all stakeholders.

Here are our position papers:
Transparency on Clinical Trial results:

The pharmaceutical industry recognizes that there are important benefits associated with making clinical trial results widely available to healthcare practitioners, patients, and citizens, and actively supports their publication. The posting of clinical trials on public registers serves an important function for patients and their health care providers to learn about and gain access to relevant clinical trials of experimental treatments or preventative agents and authorized medicines.  

For more information on what clinical trial data is and what is publicly available today please see this presentation:

For more information on where to find clinical trial results, please see: http://clinicaltrials.ifpma.org/clinicaltrials/no_cache/en/myportal/index.htm & http://www.clinicaltrials.gov

EU institutional calendar on the issue of Clinical Trials:

Please find here an overview

Commission proposal: COM(2012)369

Title: Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Procedure: Ordinary legislative procedure (ex-codecision)

European Commission DG: SANCO
Council:

Timetable: 

Date:

Event:

6 Nov 2012

CWG on Pharmaceutical and medical devices

11 Dec 2012

CWG on Pharmaceutical and medical devices

11 Jan 2013

CWG on Pharmaceutical and medical devices

 

 

ENVI – Lead committee
Rapporteur: Glenis Willmott (S&D, UK)

Shadow rapporteurs:

Philippe Juvin (EPP, FR)

Antonyia Parvanova (ALDE, UK)

Margrete Auken (Greens/EFA, DK)

Milan Cabrnoch (ECR, CZ)

Date:

Event:

18/19 February 2013

Consideration of draft report

26 February 2013

Deadline for amendments

20/21 March 2013

Consideration of amendments

24 April 2013

ENVI Vote

10 June 2013

Plenary vote

 
 ITRE – Opinion committee

Draftsperson: Michele Rivasi (Greens/EFA, FR)

Shadow opinion

Françoise Grossetete (EPP, FR)

Date:

Event:

23 January 2013

Consideration of draft opinion

31 January 2013

Deadline for amendments

19 March 2013

ITRE vote

 
IMCO – Opinion committee

Draftsperson: Cristian Silviu Busoi (ALDE, RO)

Shadow opinion

Philippe Juvin (EPP, FR)

Christel Schaldemose (S&D, DK)

Heide Rühle (Greens, DE)

Emma McClarkin (ECR, UK)

Matteo Salvini (EFD, IT)

Date:

Event:

23/24 January 2013

Consideration of draft opinion

31 January 2013

Deadline for amendments

20/21 February 2013

Consideration of amendments

20 March 2013

Consideration of compromise amendments

21 March 2013

IMCO vote

 
Links to EFPIA Members Associations website pages on Clinical Trials
Events
  • Commission Proposal on Clinical Trials, with  Prof. Dr. med. Jörg HASFORD, Chairman of the Working Group on medical ethics committees in Germany, Glennis WILLMOTT (S&D), Rapporteur Clinical Trials Regulation, Philippe Juvin, EPP Shadow Rapporteur - 15:30, Wednesday 16 January 2013 - SDM S3, European Parliament Strasbourg.

  • "The Future of Clinical Trials",   Hosted by Rebecca Taylor MEP - 16.00 – 18.00, Monday 28 January 2013 - PHS 5 B001, European Parliament Brussels
  • "Enhancing paediatric research in Europe through the EU Clinical Trials Regulation", hosted by Glenis Willmott MEP - 15.00 - 18.00, Wednesday, 20 February 2013 - A311-1, European Parliament Brussels
  •  "Faster Access to Medicines for Rare Disease Patients",  10.00 - 14.00,  Tuesday 26 February 2013, Brussels