January 7, 2013 | By Márcio Barra
2012 just came and went, and it’s no surprise to anyone that Portugal was hit hard by the current (and seemingly endless) European crisis. Current austerity measures and expenditure restraints are hitting hard all sectors of the Portuguese economy, and we here at Pharmaupdates wonder how the previous year fared for clinical trials in Portugal.
Let’s start with the raw data, available through Infarmed.
In 2012, there were 86 authorization requests for clinical trials sent to Infarmed. Of those 86, 76 were given the green light and were authorized. In 2011, there were 88 authorization requests, and 87 were approved by Infarmed. So, overall, from 2011 to 2012, about the same number of clinical trials requests were submitted to Infarmed, but 11 less were approved by Infarmed. Greater regulatory scrutiny? Maybe!
(sidenote: details from previous years are available from Infarmed, or, through this report: https://pharmupdates.wordpress.com/2013/01/02/clinical-trial-investigation-in-portugal-5-year-report-2007-2011/)
A small decrease in numbers, but a decrease nonetheless. 76 trials were authorized to start in Portugal in 2012, a far cry from previous years who were well over 100 trials authorized. In a year were more and more restraints are placed in hospitals to contain expenditures, this decline can be costly to hospitals, as clinical trials are an important source of revenue for them.
It’s no wonder that Apifarma, in their study released at the launch of the Portuguese National Platform for Clinical Trials, that because of a lack of capacity, gaps in training and awareness of hospital administrators, physicians, nurses and pharmaceuticals, the absence of a strategic framework plus an unbalanced resource management, Portugal is the less attractive country in Europe for conducting clinical trials. And money is lost. 14 million euros.
To combat this decline in numbers, Infarmed launched in 2012 a national portal for clinical trials, the PNEC, with hopes of being an important tool in increasing clinical trials in Portugal, especially early phase ones, and it hopes to improve on the evaluation procedures of Infarmed andcontribute to the creation of specialized formation centers in Portugal. It’s too early to tell if it’s working or not, but it shows that the national competent authority is concerned with these numbers and taking action.
What about the sponsors? Who are the companies that sponsored clinical trials in Portugal in 2012?
With the information pharmaupdates collected through clinical trial register, the top 8 sponsors, who had the most clinical trials approved by Infarmed in 2012 are presented below:
|Sponsor||Number of approved trials in 2012|
|Merck Sharp & Dohme Corp.||7|
|Janssen-Cilag International NV||6|
|Novartis Pharma AG||5|
|F. Hoffmann-La Roche Ltd.||5|
|Astellas Pharma Europe B.V||3|
|GlaxoSmithKline Research and Development Limited||3|
So, in 2012, Merck Sharp & Dohme was the sponsor that had the most trials approved by Infarmed, with 7 trials total. Why top 8? Many sponsors had two trials approved, so it’s difficult to arrive at a tiebreaker between all of them for a proper top 10.
As for the list itself, it’s non-surprising. The lack of academic sponsors is a trend that has been happening more and more (in 2012, only 2 trials from academic sponsors were approved). Commercial sponsors are the main players in the Portuguese landscape.
Can Portugal turn around this tide, become a more attractive place for investors and attract more trials? Surely it can, and its drug regulatory agency is taking solid steps, in this complicated economic outlook, to improve these circumstances. But there is still much work to do in the hospital field if it hopes to improve.