European Medicines Agency holds international workshop on clinical trials

European Medicines Agency (EMA)On 6-7 September 2010 the European Medicines Agency (EMA) held an international workshop with a broad cross section of stakeholders from around the world to discuss a way forward for a global framework of clinical trials that has at its heart the protection of the rights, safety and wellbeing of patients participating in clinical trials anywhere in the world.

The workshop was part of the consultation process on the Agency's 'Reflection Paper on ethical and Good Clinical Practice (GCP) aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA'.

Some 170 participants from around 50 countries from the Americas, Asia, Africa and Europe came to the meeting at the Agency in London to provide their feedback on the draft Reflection Paper and discuss international cooperation in this context. They represented patient organisations, health-related non-governmental organisations, clinical trial sponsors, pharmaceutical industry, ethics committees, regulatory authorities from all continents and intergovernmental organisations.

The Reflection Paper responds to the challenges arising from the increasing globalisation of clinical research. In marketing authorisation applications submitted to the Agency between 2005 and 2009, only 38.8% of patients enrolled in pivotal clinical trials received their treatments at clinical trial sites within the EU and EEA. These trials involved more than 44,000 clinical trial sites in 89 countries. The data generated was used to support 347 marketing authorisation applications as well as some applications for a variation or a line extension of the existing marketing authorisation.

"Wherever in the world we stand, the majority of clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in different cultural settings. However, we all rely on the same trials to make decisions: as regulators, to allow or disallow marketing authorisations, and, as patients and healthcare providers, to use or not to use a medicine," said Fergus Sweeney, Head of Inspections at the European Medicines Agency.

A number of practical proposals and recommendations are set out by the Reflection Paper. It was considered that EU regulators should only expect or require studies in support of an EU marketing authorisation application that would also be ethically acceptable in the EU. There should not be a different standard applied to trials conducted in the EU compared to those conducted elsewhere.

The discussions over the course of the two-day conference highlighted three main points:

  • The need for cooperation and networking between regulatory authorities and also ethics committees involved in the supervision of clinical trials, including capacity building activities.
  • The need for greater transparency of clinical trials, including clinical trials registers and the provision of information about ethical and GCP aspects in the European Public Assessment Report (EPAR).
  • The need to involve patients early on in the design of protocols to ensure the adequate protection of clinical trials subjects.

Thanking the workshop participants for their contributions, the Agency's Executive Director, Thomas Lönngren, said: "What is needed is a robust framework for the oversight and conduct of clinical trials, no matter where in the world the clinical investigator's sites are located and patients recruited. The Agency is committed to build and extend its relationship with regulators in all parts of the world and with international organisations to work to standards agreed and recognised by all."

The consultation on the Reflection Paper is open until 30 September 2010 and comments should be sent to This email address is being protected from spambots. You need JavaScript enabled to view it. All comments received during the consultation phase, including the workshop, will be thoroughly reviewed and inform the finalisation of the Reflection Paper, expected by mid 2011.

Download Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA.

Most Popular Now

How SARS-CoV-2 mutates to escape antibody binding

In a recurring pattern of evolution, SARS-CoV-2 evades immune responses by selectively deleting small bits of its genetic sequence, according to new research from the Uni...

Anticancer drug may improve outcome for severe COV…

Treating severe COVID-19 patients with the anticancer drug bevacizumab may reduce mortality and speed up recovery, according to a small clinical study in Italy and China ...

Pfizer and BioNTech commence global clinical trial…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the saf...

GSK and Vir Biotechnology expand coronavirus colla…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) have signed a binding agreement to expand their existing collaboration to include the resear...

One dose of COVID-19 vaccine provokes strong immun…

Although clinical trial data are encouraging, real-world evidence with regard to the COVID-19 vaccine remains scarce. In particular, response to the vaccine among those p...

Johnson & Johnson announces submission of appl…

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting E...

Could a nasal spray prevent coronavirus transmissi…

A nasal antiviral created by researchers at Columbia University Vagelos College of Physicians and Surgeons blocked transmission of SARS-CoV-2 in ferrets, suggesting the n...

European Commission purchases additional 150 milli…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission purchased an...

Johnson & Johnson Announces Submission to Worl…

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization...

Neandertal gene variants both increase and decreas…

Last year, researchers at Karolinska Institutet in Sweden and the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany showed that a major genetic risk ...

CureVac initiates rolling submission with European…

CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today annou...

Pfizer and BioNTech publish data from in vitro stu…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication in Nature Medicine of data from in vitro studies that demonstrate that sera from in...