For those of you who might not be aware, International Clinical Trials Day is this Saturday, May 20, 2017. Celebrating the first ever clinical trial conducted by Scottish physician James Lind, Clinical Trials Day raises the awareness of clinical trials while highlighting its importance.
This week, Clinical Trials Arena will be focusing the challenges of clinical trials around the globe as part of May’s ‘International Clinical Trials Week.’ Running throughout this week, CTA will post articles uncovering the most pressing issues facing industry today with each day looking at a specific continent.
Experts, such as, Shurjeel Choudhri (Bayer) and Elena Aminkova (CCTCC), will focus on the clinical trial landscape in Canada in a two-part exclusive report. Meanwhile, Marisa Piaggio (Galamad) and Valery Noviov (Genarium) will explore the regulatory aspects of running trials in Latin America and Russia, respectively.
But first, be sure to visit CTA tomorrow when Guillaume Trusz argues the case why more companies should adopt a Southern Hemisphere First strategy as an alternative to the Asia-Pacific region.
In the meantime, catch up on some CTA’s most recent stories delving into the challenges of global clinical trials... (click on the headline to finish reading).
As has been discussed in previous articles, the South African trial environment is attractive to pharma companies for trial purposes. This is due to the well established, highly experienced trial network of Doctors, as well as the variety of pathologies offered in the potential patient population – there are developing world pathologies as well as 1st world pathologies, all spread over a population of 55 million.
Brazil is a large country with over 200 million inhabitants, making it the largest population in Latin America. Divided into five regions, the country is the sixth largest pharmaceutical market in the world where regulatory compliance to clinical trials is upheld by an experienced and qualified workforce.
At first glance, these figures could be attractive for pharmaceutical and biotechnology companies. However, regulatory frameworks in Brazil are restrictive.
Many smaller biotechs outside of Europe can struggle to progress their clinical operations due to limited funding. The EU Horizon 2020 program can provide funding to support biotechs in the Middle East and elsewhere who want to outsource trials into Europe for the first time. Agora Partners offer support to companies putting together applications for these grants. Judi Felber spoke to CTA to share how her company can aid biotechs wanting to progress their clinical operations in the EU.
Exploitation or Progression? Focusing on the unethical practices of clinical trials performed in South Africa
Clinigen's recent acquisition of South African giant Link Healthcare for over 100 million pounds reflects the recent rise in popularity of South Africa as a clinical trial site of choice. According to the online registry ClinicalTrials.gov, in February 2013, over 1,600 clinical trials had been registered in South Africa with the national clinical trial business being valued in the region of 250 million Euros, and growing each year. The main reason? South Africa hosts a large pool of potential patients with little current competition from other sponsors.
Similar to Eastern Europe, China and India, South Africa has thrived as a site of quick patient enrolment. However this may hide another truth relating to the treatment of the patients within the country. This article will focus on evidence that pharmaceutical companies are exploiting the poorer South African population through the use of placebo-controlled studies and limited post-trial access to treatment.
If you have been pondering whether to employ a multi-regional strategy in your clinical development program, you are not alone. Despite the growing prevalence of global clinical trials and global registration strategies in the past two decades and the increase in the number of firms who specialize in conducting these trials, there are still a depressingly large number of ways that the unsuspecting sponsor can get it wrong and see their clinical development plans spin hopelessly off the rails. Here are a few points to consider in planning your next multi-regional project.