Clinical Research

Any research conducted to determine or confirm the clinical, pharmacological, and/or other pharmacodynamic effects, and/or to detect adverse reactions, and/or to study the absorption, distribution, metabolism and elimination of an investigational medicinal product(s) in order to determine its safety and/or efficacy.

• They may be randomised or non-randomised depending on the design.
• Insurance or financial guarantee is mandatory, except in low-intervention clinical trials.
• They do collect information on medicines.
• They require the approval of an IRB and the regulatory body in Spain, the AEMPS.

PHASE I. The question of whether the medicine is safe must be answered. The aim of this phase is to determine the highest dose that can be administered to an individual without serious side effects. Adverse effects should be mild and/or infrequent. It is performed on a small number of healthy volunteers or patients.

PHASE II. It has to be determined whether the medicine really works, i.e. whether it is useful in curing, treating or preventing the disease in question. Possible side effects continue to be closely monitored. This is done in a small number of patients, although slightly larger than Phase I.

PHASE III. In addition to further corroboration that the drug is safe and useful, it is compared with drugs already on the market. To complete this phase, it must be safer and/or more effective than existing drugs. Thousands of patients from across the country and around the world are included.

PHASE IV. The drug is already on the market, but studies of millions of patients around the world are conducted to further analyse long-term safety and efficacy.

Medical devices, instruments, devices, equipment, software, hardware, material or other article, used alone or in combination, intended by the manufacturer to be used for human beings for the diagnosis, treatment, monitoring or prevention of disease, among other medical purposes, and which must not act at the metabolic, immunological or pharmacological level.

During clinical trials, the performance of the product shall be verified and possible side effects shall be identified, which, if serious, must be recorded and reported immediately to the competent authorities.

These studies must have the favourable opinion of the AEMPS and the REC selected by the sponsor.

Observational studies are clinical research designs that aim to observe and record events without intervening in the natural course of events.

Measurements can be made over time (longitudinal study), either prospectively or retrospectively; or once only (cross-sectional study).

They can be descriptive when the aim is to describe and record what is observed, for example, the behaviour of one or more variables in a group of subjects over a period of time, or analytical, where groups of subjects are analysed comparatively without there being a process of assignment to a particular intervention, but rather this occurs in accordance with normal clinical practice, the researcher being a mere observer and describer of what happens.

These are clinical studies in which invasive tests are performed without the objectives being related to medicines (e.g. randomisation of 2 surgical techniques, study with nutraceuticals or cosmeceuticals, etc.), and whose procedures are not performed according to standard clinical practice. No drug information is collected and they may be randomised and require an insurance policy according to the decision of the Ethics Committee for Research on Medicinal Products (CEIm). These studies are governed by the Biomedical Research Act 14/2007.