What are clinical trials?
Clinical trials are used to evaluate the safety and efficacy of new drugs.
Trials are divided in four phases:
- Phase I: During this phase, a drug is tested for the first time in healthy volunteers having previously been assessed for safety and efficacy in laboratory animals. All participants at this stage must be clinically healthy, i.e. with no evidence of the disease to which the drug is targeted. The purpose of this stage is to test how the new drug is absorbed, distributed, metabolized and excreted in the human body and to find out the most frequent and serious adverse events.
- Phase II: In phase II, the new drug is evaluated for the first time in patients with the targeted disease. The main objective is to evaluate adverse effects and to gather preliminary data on effectiveness.
- Phase III: During Phase III, the drug is tested on large groups of patients. At this point, the new drug is compared with existing drugs or with a placebo to evaluate both efficacy and safety. This is the last step before a drug can be approved for the market.
- Phase IV: This is a post-marketing stage, in which information about long-term safety and efficacy is gathered from thousands of patients.
Is it safe to participate in clinical trials?
The answer is YES.
For a clinical trial to be accessible to patients, it requires the approval of a number of organisms and institutions that ensure the patients’ safety and protection.
The Clinical Research Ethics Committee is an organism designated locally at every medical research center and that consists of medical and non-medical professionals that ensure the rights, safety, and well-being of all participants in research studies.
The Spanish Agency of Medicinal Products and Medical Devices from the Ministry of Health is the institution responsible for the authorization of the clinical trial before it is launched.
In addition, clinical trials are carried out following the strict rules of Good Clinical Practice that have been agreed upon by the research community to ensure the ethical and scientific quality of the study, to guarantee the protection of the participants’ rights, and to ensure the credibility of the data collected throughout the trial.
However, despite all the efforts to avoid and minimize risks derived from the study, some unpredictable complications may occur during the study. The drug may not be effective or may cause secondary effects that could be mild, severe or that could put your life at risk.
Our medical team will gladly clarify all your concerns about the clinical trial to help you to weigh up the benefits and risks of participation.
Considerations for participation
Enrolling in a clinical trial allows:
- Access to new potentially effective treatments before they are commercially available.
- Contribution to medical knowledge. The results of these studies can help other people that will develop the disease in the future.
- Having a more active role in your own health care.
- Rigorous medical control, additional physical exams and diagnostic procedures related to the clinical trial, and without any additional cost for you. All travelling expenses will be reimbursed or a taxi service will be offered so you will not have any expenses derived from the participation in a clinical trial.
Rights of the participants
The participation in any research study is always VOLUNTARY.
Participants may withdraw from a study at any time without having any effect or penalization in their medical care. Participants may also be withdrawn from the study by the medical staff, if necessary.
Who can participate in a clinical trial?
At the Memory Unit we perform Phase II and Phase III Clinical Trials, aimed at patients with Alzheimer’s disease or with Lewy Body Dementia at different stages.
Clinical trials define a set of specific characteristics or eligibility criteria that restrict the enrollment to certain patients. By doing this, the population of the study is more homogeneous and this increases the chance of finding significant results.
If you are interested in enrolling in one of the clinical trials that are currently active at the Memory Unit or need more information, please, send us an e-mail to estudismemoria@santpau.cat.