What is involved in a clinical trial?

18/01/2022

We are now more aware than ever that the treatments for many diseases are ineffective or sometimes even non-existent. In these cases, research is fundamental so that, one day, the patients suffering from such illnesses can receive a better diagnosis and treatment. 

Without research, new treatments that control or eradicate some diseases cannot be developed. Patient participation in clinical research is vital, beyond what participating in a clinical trial (CT) means. Clinical trials are an essential step in innovative treatments reaching patients and them benefitting from them. 

All participants in a clinical trial have rights (established in the informed consent form) and are protected by the law when they decide to participate. It’s particularly important that the patient has all the necessary information before deciding to participate in a clinical trial.

To take part in a clinical trial, you must: 

Meet the medical requirements or inclusion criteria which are specifically explained in the study protocol: age range, sex, have a certain type of illness, medical history, previous treatments, etc. These aspects determine your eligibility for participating (or not) in the study and ensure that the outcome of the trial is not influenced characteristics inherent to the participants, and the only differences are related to the drug. It is the doctor who will confirm whether the patient does or does not fit the inclusion criteria, and assess if they are a candidate to participate in a clinical trial.

Sign an informed consent form: a voluntary agreement the patient signs to participate in a clinical trial once they have understood the information provided to them about the objectives of the study, the benefits of the treatment, the possible side effects and risks as well as their rights. 

Take tests: If you are admitted to take part in a clinical trial, you may have to undergo various tests (blood tests, examinations, etc) before you are given any treatment as part of the study.

The objective of the clinical trials is to analyse, on one hand, the efficacy of a medication or therapy, that is to say, if it has an effect on the disease and its symptoms. And on the other, to study its safety, checking whether it has side effects. It is compulsory and essential that the drug meets both requirements for the health authorities to approve a new drug. 

Many people ask if it safe to take part in a clinical trial. Clinical trials are governed by principles or rules that guarantee they are performed ethically, safely and in accordance with the provisions of a strictly followed protocol. The safety of those participating in the clinical trial is paramount, as is their freedom to participate and leave whenever they want, without this affecting their subsequent medical care.

Clinical trials are submitted for the assessment and approval of the health authorities and research ethics committee before they can be initiated. 

At present, a centre’s clinical research is a guarantee of its quality. 

At the Barraquer Centre, we work to advance research, and for a future with even more research projects that include a high percentage of patients and contribute to identifying new treatments that can improve the quality of life of those suffering from a type of eye pathology.

Victòria Hernández Grima, Head of the Clinical Trials Department at the Barraquer Ophthalmology Centre