We are constant witnesses of the arrival of new medications and medical treatments. Its objective is to solve health problems that are sometimes very serious and we know that they are a determining factor in the increase in life expectancy of our population. By definition, a medication acts on our physiology and, therefore, can have adverse effects. In European history we have the case of the thalidomide, whose effects are still suffered by current patients. To avoid these cases, evaluation systems for new medications have been launched around the world. To carry out this task both in the United States and in Europe we have toagencies recognized for their rigor. It is about ensuring that the medications that arrive are effective and, if they have side effects, they are known and can be controlled. A key element in this system is what they call clinical trials.
Clinical trials are highly regulated procedures that try to ensure the safety and effectiveness requirements of new medications. In Europe they were regulated by a Directive approved in 2001 which, in particular, seeks to ensure that all participants in trials do so with adequate safety guarantees and have given their free and informed consent. Is about long and expensive procedures that, from the moment of discovery of a promising product until its approval, They can last about 15 years and cost about 2,000 million euros. This cost decisively influences the final price of the medicine and has also influenced the concentration of the pharmaceutical industries that must be able to finance them. In 2017 a new European Directive was approved on the issue in which it was precisely a matter of simplifying some procedures.
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This entire system is designed to ensure that when a medication is made available to potential patients, it will have the intended effects and will not produce negative effects beyond those that may be known. It may happen that they appear Negative effects once a drug has been approved and that is why there is a system called pharmacovigilance. But it is clear that people who suffer from a disease are interested in accessing new treatments as soon as possible. As the process until final approval is difficult and long, it is possible to authorize the use of a treatment before it is approved if there is no other alternative. This is done with authorization from the Medicine Agencies and of the hospital monitoring committees.
Catalonia is one of the places in Europe where the most clinical trials are carried out, more than a thousand a year. ANDhe Vall d’Hebron Hospital and the Hospital Clínic are leaders in this activity. For hospitals, trials are a way to provide them to their patients, to stay up to date with the latest developments in innovative treatments, and they are also a primary source of financing. Most trials are carried out in collaboration with companies, but there are also treatments that may have been developed by the hospitals themselves and in some cases their use is allowed before final approval. The balance between rapid access to new possibilities, their safety and effectiveness must be maintained and is not always easy. And we must not forget that, especially in the early stages, The cost of new drugs can be high and someone must make the decision about how they are paid for. That the entire procedure is carried out transparently is an essential requirement.