Important aspects

What is a clinical study?

It is a research study on human subjects with the aim of answering specific questions about a new medical treatment (vaccines, new therapies or new ways to use known treatments). Clinical studies (also called medical research and research studies) are used to determine if new medications or treatments are safe and effective

Pharmaceutical clinical studies are carried out in phases. The studies in each phase have a different purpose, and each phase analyzes different areas (e.g. toxicity (if it produces damage), what is the optimal dose, what effect it has on the disease, etc.)

What are PHASE I clinical studies?

Phase I studies (sometimes called early treatment studies) aim to understand how the new drug behaves and is distributed in the body. Several doses of a new drug are tested to find out what side effects they have, for example, if it makes people feel sick, increases their blood pressure, etc. Phase I studies involve only a small number of people, who are generally healthy volunteers. There are exceptional cases, for example, patients with cancer or HIV who are at a very advanced stage of the disease can also participate.

What are PHASE II clinical studies?

Phase II studies test the new drug in a larger group of patients to see if it has the expected medicinal effect and that if it might help them. As in phase I, the number of participants is limited. Phase II studies also analyze adverse effects (safety) and according to that we try to define the optimal dose

What is PHASE III of a clinical trial?

A phase III clinical study is implemented only if phases I and II suggest that a substance could be really useful in a way that physicians, health authorities and patients consider important. Phase III studies test new drugs in larger groups of patients

Phase III studies compare new drugs with an approved and used treatment for the disease being studied. Occasionally, if the case is worth, it is tested against a placebo (which is a substance that lacks curative action, but produces a therapeutic effect if the patient takes it convinced that it is a really effective medicine). These studies analyze how well the new treatment works in practice and any side effects. They usually last longer than phase II tests, typically a year or longer. They often include several thousand patients in multiple countries

Why is it important to participate in a clinical study?

Because it is the only scientific way to know if a medicine is useful or not. If all patients refused to participate in the clinical studies, the modern medical advancement would be stopped. Those patients / subjects who participated in the studies are the anonymous benefactors of medical progress

Who regulates clinical studies?

To obtain the approval of a clinical study, a pharmaceutical company must send to the national health authorities the “study protocol” in which all the details of the study are described. This protocol is reviewed by health authorities and also by an ethics committee, whose function is to evaluate all aspects related to the dignity, rights, safety and welfare of people who participate in medical research. If the health authorities and the ethics committee do not approve the protocol, then the study can not be initiated. Any change in the protocol must also be approved by the ethics committee

An ethics committee must have at least 5 members and is made up of health professionals and community representatives

The World Medical Association has developed the “Declaration of Helsinki”, which establishes the ethical standards for research with human beings, human material or identifiable data. Researchers will declare that their clinical study protocol has been developed in accordance with these ethical principles. Moreover, regulatory agencies of countries such as the National Institute of Health in Peru, the Food and Drug Administration (FDA) of the United States, the Agency for the Evaluation of Medicinal Products (EMEA), as well as several legislative texts at European Union level have very specific rules established to protect patients who participate in clinical studies

When and how is the clinical study approved?

Researchers are closely supervised by the appropriate regulatory authorities. At the beginning of any study, the doctor or researcher must request the approval of an ethics committee. The ethics committee is made up of medical staff, as well as people who have no links to the study. Its function is to ensure that the study is as safe as possible and that the “informed consent” explains all the important information to the patient

Clinical studies surveillance committee

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