News

Observational studies are those in which the researchers only observe events without intervening or altering the standard clinical practice.

From a methodological perspective, clinical research can have an experimental or an observational design, which translates into experimental or observational trials or studies, respectively.

An open clinical trial (CT) may have two different meanings based on the possibility of modifying the characteristics described in the study protocol or on the level of masking of the treatment or intervention administered.

Randomized clinical trials (RCTs) are studies in which participants are assigned to an experimental group or a control group, randomly (randomly)

We explain what the differences are between uncontrolled and controlled trials

There are several types of clinical trial designs. Let's see the complete classification.

A clinical trial cannot be started until it has been approved by the competent agencies designated by law. In Spain, approvals are granted by the  Spanish Agency of Medicinal Products and Medical Devices (AEMPS) and an accredited Medical Research and Ethics Committee (MREC). 

In this article, you will find the Spanish regulations that makes reference to clinical trials with drugs as described in laws, royal decrees, orders and resolutions.

The International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline,is an international ethics and scientific standard for the design, conduct, documentation, and reporting of clinical trials conducted in human beings. 

Clinical trials are one type of clinical research designed to assess experimental drugs or treatments in human beings.

 Clinical trials are scientific research studies intended to assess the efficacy and/or safety of drugs, medical devices, vaccines, therapeutic medical procedures, and diagnostic tests. 

In September, we will host an introductory course in collaboration with The MSL Project, that will be held in Madrid.