Infarmed authorized 142 requests for clinical trials in 2019

in News · 26-01-2020 10:00:00 · 0 Comments

Infarmed received 142 requests for clinical trials in 2019, having authorized all of them, according to data, which points to a 15 percent decrease in the average decision time to 34 days, six days less than in 2018.

In 2018, the National Medicines Authority authorized 141 clinical trials to be carried out for the 159 orders received, almost equalling the maximum historical order registered in 2006 (160).

According to data published on the SNS Portal, 843 substantial authorizations were granted, the highest number ever, representing an increase of 53 percent compared to 2018, "with a high response capacity with an average decision time of 21 days".

The highest number of authorized clinical trials was in the areas of oncology (53), central nervous system (27), gastrointestinal and metabolic and cardiovascular system (13).

According to Infarmed, 85 percent of requests for clinical trials, a study designed to discover or verify the effects of one or more experimental drugs, were authorized on time (56 percent in 2018).

The majority of orders come from the pharmaceutical industry (128 in 2019, minus 20 compared to 2018), the rest being academic (14 in 2019, 11 in 2018).

According to Infarmed, in the last decade, most of the research in Portugal was carried out in the therapeutic areas where immunomodulatory and antineoplastic drugs (cancer drugs) operate, an area in great expansion of scientific knowledge worldwide, followed by research in pathologies the area of ??the central nervous system and the cardiovascular system.


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