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WHAT IS A CLINICAL TRIAL?
Following Royal Decree 1090/2015 , of December 4, which regulates clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies, a clinical trial is defined as:
A clinical study* that meets any of the following conditions:
The trial subject is assigned in advance to a specific therapeutic strategy, which is not part of the routine clinical practice of the Member State involved.
The decision to prescribe investigational drugs is made in conjunction with the decision to include the subject in the clinical study.
Diagnostic or monitoring procedures are applied to trial subjects that go beyond routine clinical practice.
* A clinical study is a clinical investigation related to people intended to:
To discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more drugs.
Identify any adverse reactions to one or more medications.
To study the absorption, distribution, metabolism, and excretion of one or more medications, with the aim of determining their safety and/or efficacy.
CLINICAL TRIALS BY AREAS
WHAT IS AN OBSERVATIONAL STUDY?
Observational research refers to research concepts that aim to "observe and record" events without interfering with their natural course.
Measurements can be made over time (longitudinal study), which can be prospective or retrospective; or by one method (cross-sectional study).
On the other hand, it can be descriptive, in which it is necessary to "describe and record" what is observed, such as the behavior of one or more variables in a group of subjects over a period of time; or analyses that allow "comparing groups of subjects" without the process of assigning the studied individuals to a specific intervention, so the researcher is merely an observer and a simple description of what happened.