Last week a report was published by the European Medicines Agency (EMA) on clinical trials submitted in marketing-authorisation applications (MAAs) to the regulatory body, providing an overview of participant distribution and geographical location of clinical trials.
According to the agency, in the six year period up to December 2011, 62% of patients in pivotal trials were recruited outside the EU and Switzerland with patient trends in the Commonwealth of Independent States (CIS) – Russia and ex-USSR countries – rising to account for 7.5% of patients in 2011, from less than 1% in 2005.
Speaking with Outsourcing-Pharma.com, Dr. Petr Denisov from St. Petersburg-based Synergy Research Group said the “role of Russia (and other ex-USSR countries) in international clinical trials has [risen] significantly since the beginning of 21st century,” with 23% of all sponsors in 2012 being Europe-based pharmaceutical companies, and a further 15% from the US.
The top five foreign sponsors of clinical trials in Russia between 2006 and 2013, according to Denisov, were led by GlaxoSmithKline and Novartis who were both involved in 175 trials over the period, with 29,577 and 15,433 respectively. Sanofi-Aventis, Roche and Merck & Co. completed the list.
However, Denisov did warn that “recent changes in Russian legislation” could affect foreign-led clinical trials as the country establishes regulations towards its Pharma 2020 plan, unveiled in 2011 by then Russian PM Vladimir Putin.
“The most recent changes in Russian legislation led to a decrease of number of first-in-human trials with new medications,” said Denisov, but on the other hand there has been an increase in the “number of bioequivalence and international multicentre studies because all new medications has to be studied in Russia in order to get marketing approval.”
Synergy - who publish regular ‘orange papers’ on clinical trials in Russia - reported an overall 60% increase in clinical trials in 2012 over the previous year. Multinational multi-centre clinical trials stood at 377 new studies (41% of the total) whilst bioequivalence studies grew from 85 studies in 2011 to 322 in 2012.
Global Spread of Clinical Trials
Other findings in the EMA report saw increased clinical trial participation from other non-traditional markets - the Middle East, Asia and Pacific regions grew from 2% to 12.8% of total patients in EMA MAAs in six years – whilst the EU and USA dropped by 5% and 11% respectively.
Rebecca Harding, a spokesperson for the EMA, told Outsourcing-Pharma.com that the trend towards globalisation of clinical trials could be explained by a number of factors.
She said: “The healthcare systems in many countries are developing and so is their ability to participate in and attract clinical research. Difficulties in recruiting patients and the cost of clinical trials can also explain this trend.”
When asked about being able to guarantee good clinical practice (GCP) as trials spread across the globe, Harding pointed us towards last year’s reflection paper on ethical and GCP aspects of clinical trials conducted outside of the EU / EEA and submitted in MAAs to the EU regulatory.
According to Harding, “The paper put forward concrete steps for international cooperation in the regulation of clinical trials, with a specific emphasis on capacity-building initiatives for a common approach to oversight of trials.
“It also clarifies and determines the practical steps by which EU regulators will gain assurance that ethical and GCP standards are applied to clinical trials for human medicines, both during the development and during the marketing-authorisation-application phase.”