What is a Clinical Trial?

What is a Clinical Trial?

Clinical trials are studies that evaluate promising new treatments in patients.

A clinical trial is only conducted when there is reason to believe that the treatment under study may be beneficial to the patient. Treatments used in clinical trials often prove to have real benefits. In fact, the results of many of them have changed clinical practice by improving those used in the past.

Before a clinical trial is started, the drugs are required to pass several filters aimed at guaranteeing the safety of the participants in the trial. Following the guidelines of the Research Ethics Committee, a clinical trial is never performed if the benefit expected to be obtained fails to outweigh the potential risks.

Participants are closely monitored during all phases of the trial and are offered an optimal health care governed by the principles of Medical Ethics.

Controlled clinical trials are essential for the approval of a new drug in accordance with the Spanish General Health Law.

The improvements achieved in the field of cancer treatment in recent years are mainly due to the conduct of such clinical trials. Therefore, the role of the participants in these trials is paramount for advancing science.

The level of excellence of the oncology services offered in first world countries is mainly measured by the number of patients treated within clinical trials. This is logical, for research must be encouraged until 100% effective treatments become available. Research saves lives.

Types of Clinical Trials

Initia Oncología conducts clinical trials evaluating treatments for different types of cancer, such as breast, gastrointestinal, gynaecological, lung, or urogenital cancer, focusing both on curing the disease and improving the patients’ quality of life.

The physicians at INITIA Oncología actively participate in the development of clinical trials. They are active members of national (GEICO, GEMCAD, GEIS, etc.) and international (EORTC, GCIG, etc.) research groups and cooperate with different national and international hospitals. This experience allows for providing the patient with safety and access to new studies.

There are different types and phases of clinical trials. The main objectives of each are usually linked to parameters that assess the efficacy and safety of the new treatments.

Clinical Trials in Spain

Several research projects and clinical trials related to different types of cancer (breast, colon, prostate, melanoma, sarcomas, etc.) are currently being performed in Spain. In fact, our country is one of the European nations with the most active oncological clinical trials.

Research in the field of Oncology has increased by almost 20% over the last decade in Spain. About 37% of the clinical trials that are carried out in our country are focused on the research of drugs used in different cancer treatments and are promoted by public bodies, researchers, and pharmaceutical companies.

In Valencia, Initia Oncología actively participates in different clinical trials evaluating the treatment of several types of tumours.

Phases of a Clinical Trial

Pre-clinical laboratory studies and animal testing are always carried out before starting a clinical trial. Only when the results of these preliminary tests support the efficacy of the drugs is research with humans started.

Thus, there are four phases of clinical trials:

Phase I

Clinical trials in this phase aim to determine the appropriate dose of the drug, which is equivalent to the maximum amount that can be safely tolerated. Patients are followed closely to monitor the possible occurrence of adverse effects. The established dose will then be used in the subsequent phases.

Phase II

The aim of this phase is to perform a preliminary assessment of the effectiveness of the new treatment on a given type of tumour. A detailed study of the effectiveness of the treatment and a very controlled follow-up of possible side effects is carried out during this second phase. Participants in this phase have usually already received the standard treatment for their type of cancer. The potential decrease in the tumour size (complete, partially stable, or progression) is measured according to established and universally accepted parameters as a means to evaluate the results of the treatment.

Phase III

The aim of this phase is usually to compare the results obtained in the phase II trials with those of the standard treatment and/or other alternatives.
During this phase, the drug is administered to a much larger group of patients with the same type of cancer acting as representatives of the general population for whom the treatment will be indicated. This phase can last several years and the drug can be tested on thousands of patients. If the treatment is successful, it can be approved for marketing by the relevant authorities.

Phase IV

Post-marketing clinical trials are carried out on the drug during this phase, usually at the request of the pharmaceutical company itself, to verify the results and effects of the treatment in the long term.

FAQ

Is participation in a Clinical Trial voluntary?

Yes, all patients who participate in clinical trials are volunteers. As stated in the Spanish Medicines Act regulating clinical trials (Spanish Royal Decree 2015), participants are free to abandon the study at any time, both before and during the conduct of the study.
Patients who are expected to participate in the trial will receive all the necessary information before the start of the clinical trial, both verbally and in writing (tests that will be carried out, possible benefits and risks, treatment of their information, etc.).

All of this information is included in the informed consent, by means of which the patient authorises to participate in the clinical trial.

You can also ask your oncologist any questions that you might have about the trial before or during its development.

Who is involved in a clinical trial?

In addition to the participant, the investigator, the sponsor, and the monitor are also involved in a clinical trial.

The investigator, who is usually your attending physician, is responsible for conducting the trial at the site. If the investigator is not your physician, your usual physician and nurse will continue to be responsible for your medical case. Collaborating researchers may also assist the principal investigator during the clinical trial.

The sponsor is the promotor of the execution of the trial and is usually a clinic, a pharmaceutical company, or the trial’s investigator. The sponsor is responsible for the correct monitoring and efficient management of the procedures performed and the results obtained.

The monitor is a professional with appropriate scientific training for the trial under way. S/he is responsible for supervising the trial and ensuring that all requirements and good practice standards are met.

How to Participate

If you wish to participate in a clinical trial, you should ask your physician if there are any clinical trials available that you might benefit from. If the researchers believe that a person qualifies to enter the study, s/he may participate in it.

However, given that the risks and benefits differ among studies, it must be noted that it is essential to carefully read all of the information provided and to ask any question that may arise before signing the consent form.

In any case, participation is free and voluntary and you may abandon the trial at any time. Researchers may also remove a participant from a trial if they believe that their health is at risk.

Participants or their representatives (patient associations) are required to form part of the Ethics Committee of each clinical trial and may be involved in the entire process.

Participation in a clinical trial should always be an altruistic act. The legal regulations require that no influence be exercised on the participants, including those of voluntary nature.

However, participation entails no cost to the patient either, as the supply of the study medicines is completely free and provision is made for the reimbursement of any costs incurred by the patients due to their participation.

If you wish to take part in a clinical trial, please consult your Initia Oncología physician and s/he will inform you of whether or not you meet the required criteria for receiving treatment within a clinical trial and of how to proceed to participate in the trial.

What are the Benefits and Risks of Participating in a Clinical Trial?

Participants benefit from accessing the newest treatments under study and might increase their chances of healing or improving their condition. In addition, given that more tests might be performed during a follow-up period of the trial or to detect possible side effects, this would entail a closer and more thorough monitoring of the patient.

Furthermore, participants help advance science and assist other patients, both current and future, by enabling it to improve current treatments and increase the chances of curing cancer.

Although strict safety measures are followed and the drugs have been tested previously, there are certain risks associated with participation in a trial, such as the occurrence of adverse effects. However, a Safety Committee monitors the possible appearance of these effects. In addition, both the physician and the patient may stop participating in the trial at any time.

Why Participate in a Clinical Trial?

The main reason is that conducting clinical trials helps to advance science and, in the case of cancer trials, to find a possible cure for cancer. Thus, it helps not only you, but also other patients who have the same disease.

Moreover, participants have the opportunity to receive better treatment and access drugs that cannot be found elsewhere or that will not become available for some time. In many cases, more frequent follow-up consultations are performed during the trial compared with standard clinical practice.

Changes in clinical practice are a consequence of the results obtained in clinical trials improving previous results. Research saves lives.