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About Clinical Trials

Introduction

Presentation

The choice to participate in a clinical trial is an important personal decision. The following questions is an introduction to information about clinical trials. In addition, it is often useful to talk with your doctor, family and friends about this decision.

What is a clinical trial?

A clinical trial is a scientific investigation in which a person can participate voluntarily. As in scientific knowledge, the test conditions are controlled and closely monitored. In general, the objective of a clinical trial is the safety and efficacy of an experimental drug, medical devices or diagnostic methods in patients with a certain disease or in healthy people.

For regulatory authorities to approve a new drug, it must go through different stages of development. To know which phase is your desk, you can consult with the doctor in charge of the study. The phases of an assay can be Phase I, II, III, IV.

What is a Phase I clinical trial?

The objective is to generate preliminary information on the safety, absorption, metabolism and elimination of the new treatment. In this type of trial the experimental treatment is administered to healthy participants

What is a Bioavailability study?

It is a phase I clinical trial where the bioavailability of one or more drugs is compared. Bioavailability is defined as the rate and extent to which the active ingredient or active fraction of a drug is absorbed and made available at the site of action, eg from taking a paracetamol tablet until it reaches your target in the back to mitigate the pain in this area.

What is a Bioequivalence study?

It is a phase I clinical trial where bioequivalence is established between two formulations. Bioequivalence is defined as the absence of a significant difference in the bioavailability of the formulations when administered in the same dose and under similar conditions in a properly designed study. They can be eg two different formulations (tablets versus capsules) of a developing drug or a generic medicine.

In the case of generic drugs, the characteristics of two drugs from different manufacturers are compared to establish their similarity, and it is necessary that the original medicine has been available in pharmacies for at least 10 years. That is why these studies do not investigate their efficacy or safety, already well established, but simply compare their absorption, metabolism and elimination in healthy volunteers.

What is a Phase II clinical trial?

This type of assay is the second step in the development of a new drug in humans. Generally the study in Phase II is done with people who have a disease or condition for which the new drug is being developed. The objective of these studies is to provide information on the efficacy of the drug and provide additional information on the safety of the drug.

What is a Phase III clinical trial?

It is the final phase of the development of a new drug. The dose-effect, efficacy and safety of the new drug are studied. With this phase the development of the new drug is completed and permission is requested to market it for the pathology or condition that has been tested.

What is a Phase IV clinical trial?

It is done with the drug already approved and marketed. It is usually done under the actual conditions of use. The objective is usually to measure the effects of the drug in the long term.

Who regulates clinical trials?

The Spanish Agency for Medicines and Health Products regulates the guidelines for good clinical trials. These have to be carried out according to the recommendations for Clinical Trials and evaluation of drugs in man, which are included in the Declaration of Helsinki, reviewed in the successive world assemblies, and in accordance with the current Spanish Legislation on Clinical Trials. . The Trial protocol is reviewed and approved by an Ethics Committee for investigation with medicinal products (CEIm)

What should I do before considering my participation?

First you will receive an information sheet and informed consent to read and sign. It contains all the information to consider about a clinical trial. Read it carefully, two or three times and if any aspect is not clear ask the study doctor or research team. Each clinical trial is different and the benefits and risks vary. Consent information is your best source of information

How is the participation and withdrawal of a clinical trial?

Participation is voluntary and in the event that it is decided to suspend, it will not entail any type of penalty or detriment to your medical care. Likewise, volunteers can be withdrawn from the study, if the study doctor or the research team considers it preferable for their health or well-being.

Who can participate in clinical trials?

Each trial is different, and those who can participate also. In general, in studies with patients, your doctor will tell you about the possibility of participating in the study, explain what it consists of, the procedures to follow and give you the information sheet so that you can read it carefully and express your doubts. Also, you will be informed that at any time you can leave the study if you wish.

In the case of studies with healthy volunteers, the participants are usually men and women of legal age and in possession of their mental faculties in which, after being given a clinical history, a physical examination and other complementary tests, the results show that the criteria are met of health specified in the study protocol.

Can participation cost me something? Will I be paid?

In general, there is no cost for participants in clinical trials. In some studies volunteers are paid for their participation. The compensation is proportional to the duration and the inconvenience caused. It is a modest amount to cover the displacements and inconveniences of the study and will vary depending on the visits or income required by the study.

What happens with the information collected about me?

The information collected about the participants will only be used for the purposes of the study. The information will be stored without you being identified by the name and your identity will not be revealed to any person except in case of medical emergency or legal requirement. All the personnel related to the trial are obliged to protect the confidentiality of their data according to the Organic Law of Protection of Personal Data (15/1999 of December 13). Participants can access the information collected through their doctor and ask to correct any error in it. If the results of the study are published your identity will also be confidential.

Facultad de Medicina de la Universidad Autónoma de Madrid. Calle del Arzobispo Morcillo 4. 28029 Madrid. Tel. +34 91 497 54 86  Fax. 91 497 53 53. Email. informacion.medicina@uam.es