clinical trials

Clinical Trials

What are clinical trials?

Clinical trials are studies of new drugs to determine their tolerability and efficacy.

Clinical trials are divided into four phases:
PHASE I+
In this phase, the investigational drug is administered to humans for the first time (FIH, First-in-human). Participants may be healthy volunteers or patients, depending on the drug’s characteristics, its risk profile, and the disease being studied. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and, where applicable, the pharmacodynamics of the treatment.
PHASE II +
The drug is administered to patients with the condition for which it is indicated. The goal is to obtain preliminary information on its efficacy, determine the most appropriate dose, and continue to evaluate its safety and tolerability by monitoring for possible adverse effects.
PHASE III+
A large number of patients participate in this phase. The investigational drug is compared, where appropriate, with the available standard of care, a placebo, or another therapeutic strategy. Its objective is to confirm the efficacy and safety observed in previous phases and to evaluate the benefit-risk profile. The results of this phase form the basis for applying for marketing authorization.
PHASE IV+
These studies are conducted after the drug has been approved and marketed. They involve a large number of patients and provide additional information about the drug’s safety and effectiveness under real-world conditions, identify rare or long-term adverse effects, and evaluate its use in specific populations.

Is it safe to participate in clinical trials?

The answer is always YES.

When participants are invited to take part in a clinical trial, the trial has already gone through a series of agencies and institutions that ensure the protection and safety of its participants:

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IRB

The Institutional Review Board (IRB) is a body that exists in every hospital and is composed of healthcare and non-healthcare personnel who safeguard the rights, safety, and well-being of research study participants.

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AEMPS

The Spanish Agency for Medicines and Health Products of the Ministry of Health is the agency that authorizes the trial before it begins.

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Good Clinical Practices

In addition, clinical trials are conducted in accordance with rigorous Good Clinical Practice guidelines that ensure the ethical and scientific quality of the study, guarantee the protection of patients’ rights, and ensure the credibility of the clinical trial data.

Although clinical trials are designed to minimize risks, no treatment is entirely risk-free. Adverse effects or unexpected complications may arise during the study, which is why participants are closely monitored by the research team throughout the study.

It is very important that you discuss any questions you may have with the healthcare professionals who are offering you the opportunity to participate in the study so that you can weigh the benefits and risks of participating in the clinical trial.

Vías de administración

There are various clinical trials with different routes of administration:

💊 Oral
💉 Subcutaneous
🩸 Intravenous
🧠 Intrathecal

Things to consider before participating

Participating in a clinical trial allows you to:

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To have access to innovative treatments that are potentially effective before they are marketed.

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Contribute to medical knowledge. The results of clinical trials can help people who will develop the same disease in the future.

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Play a more active role in taking care of your own health.

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You’ll undergo rigorous medical monitoring, physical exams, and tests related to the clinical trial, at no cost to you. You won’t incur any expenses related to the trial, as travel expenses will be reimbursed or a taxi service will be provided.

Volunteers’ rights

Participation in any clinical trial is always VOLUNTARY.

You have the right to withdraw from the trial at any time, without this resulting in any penalty or adverse effect on your future medical care. It is also possible for a patient to be withdrawn from the study if the trial physician deems it appropriate.

Who is eligible to participate?

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Patients with Alzheimer’s disease

At the Memory Unit, we participate in Phase I, II, and III clinical trials for patients with Alzheimer’s disease at various stages.

Each trial defines specific inclusion and exclusion criteria to ensure the homogeneity of the study and maximize the results.

Frequently Asked Questions
Will I get the real medicine or a placebo? +
In controlled trials, some participants receive the investigational drug and others receive a placebo. This is done randomly, and in most cases, neither the patient nor the doctor knows which treatment is being administered (double-blind).
Are there any costs involved?+
No. Participation in a clinical trial is completely free. In addition, travel expenses are reimbursed, or a taxi service is provided.
Can I drop out of the trial whenever I want? +
Yes. Participation is always voluntary, and you can withdraw at any time without it affecting your regular medical care.
How do I know if I’m eligible for a clinical trial? +
Each trial has specific inclusion and exclusion criteria. The medical team at the Memory Unit will evaluate your case to determine whether you meet the requirements.

Are you interested in participating?

For referral requests, general questions, if you are interested in participating in any of the studies currently open at the Memory Unit, or if you need more information, you can email us at voluntarismemoria@santpau.cat:

✉️ Volunteers

Check out our brochure:
Tríptico EECC_CAST