Clinical trials

Clinical trials are experimental evaluations of a drug in humans to determine its safety and efficacy, allowing to find out if an investigated drug offers benefits to treat a disease that has no treatment or if it offers a greater benefit than an existing drug. Through clinical trials to investigate new treatments, it is possible to establish how effective a drug is and if it is more effective than existing ones, the side effects it can cause and at what dose it provides the best results.

• Clinical trials compare the effects of treatments or therapeutic interventions in people with a similar illness or medical condition.
• Before conducting a clinical trial of a drug, it must have been previously tested in animals (preclinical trial).
• Clinical trials are what allow physicians to continue to provide better solutions for treating patients.

The product that is the subject of the clinical trial may be a substance not authorized as a therapeutic specialty in any country, a substance authorized as a therapeutic specialty in other countries but not in Spain, or a pharmaceutical specialty authorized in Spain but which is to be used under conditions of use other than the authorized ones

In general, clinical trials compare the effects of two or more treatments or therapeutic interventions in a homogeneous group of people with a similar disease or medical condition. These trials arise in response to the ethical need to guarantee the efficacy and safety of the treatments that patients receive, in addition to, being highly protocolized, establishing a controlled, objective and reproducible method to evaluate the effects of a treatment on health in an objective way.

The ethical dimension

When experimenting with human beings, the ethical dimension of these interventions is of vital importance and a clinical trial must always be carried out according to the Spanish legal provisions that regulate them, such as Law 29/2006 on guarantees of rational use. of medicines and health products and the Royal Decree of Clinical Trials RD 1090/2015. Likewise, the European Union also establishes a framework that must be complied with by member states on the regulation of clinical trials through Directive 2001/20 / EC of the European Parliament and Council and Directive 2005/28 / EC of the Commission. European.

Before conducting a clinical trial of a drug, it must have been previously tested in animals (preclinical trial) and if it achieves certain requirements, it is when a clinical trial in humans will begin with a series of programs and staggered trials, so that the whole process can take more than 10 years.

Once a clinical trial has been designed, it must be approved by the official bodies of each participating country, the health authorities and by the clinical research ethics committee (CEIC), an independent body in charge of reviewing the ethical and methodological aspects of the clinical trial. , ensuring that the study is well designed so that the results can be valid and that the rights of healthy and sick people participating in the study are preserved as stipulated by various international agreements, such as the Declaration of Helsinki of 1964 and its subsequent modifications (the last one in Fortaleza, Brazil in October 2013), respecting the principles of justice, non-maleficence, beneficence and autonomy of the participants. It ensures that every potential participant in a clinical trial is duly informed of the objectives, methods, anticipated benefits and potential dangers of the study and the inconveniences that they may entail, informing that they are free not to participate in the trial and to abandon it at any time. . All this information is collected in writing in a legal document that is the informed consent and that all trial participants must read, understand and sign.

Once the study is established and approved by the relevant institutions, the participants will be recruited following inclusion and exclusion criteria and the study will be carried out. Once carried out, the results will be analyzed using statistical tools to determine whether or not the objectives of the trial have been met, if the results are significant, and thus communicate this to the scientific community.

Different phases

Clinical trials are always prospective, that is, they are planned and then carried out, following the evolution of the participants over time. They consist of various phases in which different factors are determined and different people participate:

• Phase I: the effectiveness of a drug is studied in humans and it is determined in healthy people how the drug is metabolized and behaves in the body, the effects it produces and the most appropriate dose and administration schedule. The groups of this first phase are usually of less than 100 people and all healthy. Participants receive financial compensation for the inconvenience suffered by an amount never so high as to induce a subject to participate for financial reasons.
• Phase II: it is carried out with patients suffering from the disease or clinical entity of interest. It provides preliminary information on the efficacy of the product, establishes the dose-response relationship and expands the data on the safety of the drug. They are groups of between 100 and 200 participants that are divided into two groups, a control group that is compared with the one receiving the drug that is being studied. When trials are conducted with control groups that receive either an existing treatment or a placebo, it is intended that neither the patients nor the treating physicians know who is receiving which treatment to avoid bias and ensure the objectivity of the study (double-blind study ).
• Phase III: allows to confirm the therapeutic benefits of the new drug and its safety, comparing hundreds of patients in different medical centers, trying to reproduce the usual conditions of use and considering the therapeutic alternatives. It is carried out in a much larger and more representative sample of patients from the general population, the studies being randomized and always with a control group.
• Phase IV: the drug is monitored once it is marketed (pharmacovigilance), detecting previously unknown toxicities, exceptional adverse reactions or even unforeseen beneficial effects of the drug.

Thus, clinical trials are what allow doctors to continue providing better solutions for the treatment of patients and it is thanks to the collaboration of the participants that with each passing year it is possible to heal more and better our patients.

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