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.)

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.

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

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

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

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

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

It may be that you suffer from a chronic illness and you are interested in participating, because this way you would help find better treatments that are non-existing today; or also, it may be that the disease you suffer has a strong genetic component and you would like to contribute developing new medicines that are better than those you receive today and so you could benefit and your offspring also in the future

If you suffer from a disease that does not yet have a known beneficial treatment, and you want to contribute to check if the study medicine plays a role in improving your disease

The cost of a clinical study is assumed by the company that wants to develop it, and therefore your participation is free of charge; however, If your main motivation is to participate in a study to obtain free medicines, you are minimizing the risks that any study has in favor of an economic benefit

Under no circumstances or situation you can be forced to participate in a clinical study. At Clínica Ricardo Palma, there is a clinical studies monitoring committee that you can go to for any clarification

You can not join a study without signing a form stating that you have given your informed consent, except in exceptional circumstances. If you sign this form, you confirm that you believe that you have been provided with all the important information about a study, that you understand it and that you have decided to participate in the study of your own free will. An informed consent is not a contract and you can withdraw from the study at any time without risking your usual treatment

The clinical studies surveillance committee of Clínica Ricardo Palma has authorized the following research centers in accordance with the regulations and approval of the National Institute of Health

Thorax Research Center
Av. Javier Prado Este 1066, fourth floor  B Tower, Urb. Corpac – 15036 Peru
Telephone: (511) 224·2224 extension 4010 / (511) 225·3445

Oncology and Radiotherapy Center
Av. Pablo Carriquirry 115, Urb Corpac – 15036
Telephone: (511) 224·1779
Hours: 9 am – 5 pm

Ricardo Palma Research Center
Calle Cinco 243, Urb Corpac – 15036 Peru
Telephone: (511) 224·2224 extension 1371 / (511) 628·7160 / (511) 628·7161
Hours: 9 am – 6 pm

Of course, since your participation is voluntary you can withdraw from the study at any time

No, because participation is voluntary in order to know if the medication is useful

If you are interested in getting more information, e-mail us at: investigacioncrp@crp.com.pe