May 20th is International Clinical Trial Day, but most people are still unaware of their importance within our healthcare system. A clinical trial is a study conducted in people to determine the efficacy and safety of a new drug or treatment. They are the primary way in which scientists and doctors find better types of treatment to advance medicine and to eliminate side effects. Their ultimate goal is to improve patient quality of life.
In 2020, the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) approved more than one million clinical trials in our country. Specifically, 34% of these trials were on cancer, with trials to find treatments for COVID-19 right behind.
Here are 10 key points about enrolling in clinical trials that everyone should know:
- Why is conducting clinical trials so important? Clinical trials are used to find new treatments that could improve patient quality of life. For cancer, trials can help determine new ways of preventing it, diagnosing it earlier and finding more effective treatments. Clinical research is the basis of all medical advances and is extremely necessary to decrease the prevalence of cancer.
- Are there different types of clinical trials? Yes, there are four types. There are trials to find new and improved treatments; screening trials, to evaluate new diagnostic processes in disease detection; prevention trials, to try to prevent the onset of the disease; and quality of life trials, to improve side effects and patient quality of life.
- What are the phases of a clinical trial? There are 4 phases in every clinical trial. Phase I analyses whether a new treatment is safe and how to administer it. Phase II looks at how the cancer responds to the treatment. Phase III determines if the new treatment is better than an existing treatment. Phase IV analyses the long-term benefits and side effects.
- Who can enroll in a clinical trial? It is up to the physician to decide whether or not a patient is eligible for this type of treatment. Moreover, each clinical trial has its own inclusion and exclusion criteria to be able to participate. These criteria may include age, sex, past illnesses, blood pressure, etc.
- How can a clinical trial benefit the patient? Enrolling in a clinical trial has multiple benefits: Access to innovative treatments, improved quality of life, and more comprehensive treatment and disease follow-up.
- What rights do participants have? Participants in a clinical trial have the right to be informed of the possible risks and benefits, to ask questions to better understand any information, to withdraw at any time without prejudice and to receive free treatment and care during the study.
- What is informed consent? Informed Consent is a process by which a patient voluntarily confirms his/her decision to participate in a given trial after having been duly informed of all aspects that are relevant to his or her decision to participate. Participants have the right to withdraw their consent for the study at any time.
- How is the patient’s process managed in the trial? People enrolled in clinical trials are closely monitored by the medical team through frequent visits, blood tests and physical examinations, in addition to having a team of experts who constantly monitor patient data.
- How is patient data protected in a clinical trial? Patient data is always anonymous and entered into a unique worldwide database for each trial. Then, using different types of analysis, conclusions on the results and their possible implementation are obtained.
- Who regulates clinical trials? In Spain, we have Medicinal Product Research Ethics Committees (mpREC). These committees are independent bodies made up of healthcare professionals and non-healthcare professionals responsible for making sure the trial is conducted in line with current regulations and ethical standards. These committees are evaluated annually by the Spanish Agency for Medicinal Products and Medical Devices (AEMPS).