#Single blind study trial

The subjects of the experimental group and the control group are arranged in pairs (one who receives the experimental treatment and the other who receives the reference treatment), are examined and added to the results obtained up to that time.Ĭlinical trial in which the elements allocated randomly are communities or populations, instead of individuals.

In explanatory clinical trials it is usually easier to avoid Type-I and Type-II errors, but their power of inference is lower than in pragmatic trials.Ī trial carried out by a single researcher or research team in one hospital or another type of centre.Īccording to Royal Decree 561/1993, “A trial carried out in two or more centres with the same protocol and a coordinator who is responsible for processing all the data and for analysing the results”.Ĭlinical trial in which each group of patients receives a single treatment simultaneously.Ĭlinical trial in which the observations are assessed as they are produced and the total number of participants is not predetermined, but depends on the accumulated results.

It is usually done in conditions which are different from those of habitual practice and includes the analysis of patients who complete the trial, as opposed to an intention-to-treat analysis. The main parameters measured are mainly biological ones (for example, deobstruction of coronary arteries in patients who have suffered a myocardial infarction). It is usually done in the earliest phases of the development of a drug, with restricted inclusion criteria, in order to obtain a homogenous sample of participants, representative only of specific sub-groups of population, of a limited size. Said of the trial whose aim is fundamentally to acquire scientific knowledge and biological explanations about efficacy. Trial in which the total population is a single patient and in which the order of administration of the treatments compared is determined in a random way. This is done when the clinical variables examined are soft, that is, they can be interpreted in different ways.Ĭlinical trial in which each individual consecutively receives each of the treatments under study. Trial in which neither the subject nor the observer know which treatment is being administered.Ĭlinical trial in which the participating subject, the observer-researcher and the researcher who analyzes the data do not know which treatment is being received. Trial in which the subject, but not the observer, does not know which of the possible treatments he is receiving. It can also be a non-blinded clinical trial, as opposed to a single-blind or double-blind clinical trial. To find out the profile of its adverse reactions and establish its safety.Īny study in which the subjects are assigned to one therapeutic intervention group or another at random, or which directly or indirectly conditions the habitual medical prescription process shall always be considered an experimental assessment.Īny study in which an unauthorized substance is used as a pharmaceutical speciality or a pharmaceutical speciality is used in conditions of use which are different from the authorized ones shall always be considered an experimental assessment”.Ĭonfusing term, used to indicate that a clinical trial does not have any specific methodological characteristic.Īn open clinical trial is a clinical trial without a control group, as opposed to a controlled clinical trial.

To establish its efficiency for a specific therapeutic, prophylactic or diagnostic indication.

To find out its pharmacodynamic effects or collect data referring to its absorption, distribution, metabolism and excretion in the human organism.

The Law on Medicines and Royal Decree 561/1993 define the clinical trial as: “Any experimental assessment of a substance or medicine, through its administration or application to humans, focusing on one of the following purposes: The clinical trial is the most rigorous epidemiological method for testing hypotheses.īy extension, sometimes any clinical development procedure of a drug is called a clinical trial. Random distribution is the best method for determining that the groups formed are comparable in all the prognostic characteristics except in the intervention they receive. Carefully and ethically-designed experiment, in which participating subjects are assigned to the different modes of intervention simultaneously (in the same period of time), at random and are also supervised in a simultaneous way.

Single blind study