If you or someone you love has Alzheimer’s disease, you may have heard of clinical trials. But what are they, and how do they work? In this post, we will explain the basics of clinical research trials, and why they are important for finding new treatments for conditions like Alzheimer’s disease.
What Are Clinical Trials
Clinical trials are research studies involving human volunteers who agree to test new drugs, medical devices, or other interventions. The main goal of clinical trials is to determine whether these new treatments are safe and effective for people with a certain condition – or if a new treatment is more effective or has less harmful side effects than existing treatments.
Do Experimental Treatments Pose a Risk to Participants?
While clinical trials may be perceived as introducing entirely unexplored treatments, they actually undergo rigorous research and testing before reaching the trial phase. Treatments in clinical trials are often thought of as totally new, but there is a lot of research and testing that happens before any kind of clinical trial gets underway. After researchers test investigational treatments in the lab, those with the most promise are submitted to the U.S. Food and Drug Administration (FDA) for review and approval to start human clinical trials.
From there, clinical trials are subject to various regulations and processes that aim to protect the safety and privacy of participants. Some of the safeguards that are in place include:
- Informed consent: A process that ensures that participants are fully informed about their rights as a participant, as well as the purpose, procedures, risks, benefits, and alternatives of the clinical trial. Once participants complete the informed consent process and volunteer for the trial, they can withdraw from the study at any time without penalty.
- Ethical committee review and approval: A process that involves an independent group of experts (such as scientists, doctors, and others) who review and approve the study protocol, the informed consent document, and any updates or changes to the study, to ensure that the participants’ rights, safety, and well-being are protected.
- Regulatory oversight: Authorities, such as the FDA, review and monitor the conduct and results of clinical trials to ensure that they comply with the applicable laws and regulations.
- Data protection: All clinical trials are required to have measures (such as data encryption or anonymization) to prevent unauthorized access, use, or disclosure of the personal and medical information collected from participants. Participants have the right to know who will have access to their data, how it will be used, and how long it will be stored.
How do Clinical Trials Work?
Clinical trials are designed to answer specific questions about the new treatment, such as:
- Does it work better than existing treatments?
- What are the possible side effects and how can they be managed?
- What is the optimal dose and frequency of administration?
- How does it interact with other medications or supplements?
- How does it affect the quality of life and daily functioning of the participants?
To help researchers find the answers to these questions, participants undergo regular testing, monitoring, and evaluation while receiving treatment. This testing helps researchers document the clinical trial’s outcome measures (i.e. the criteria for evaluating the effects of the new treatment on participants). Outcome measures can be objective (such as blood test, brain scan, or cognitive test results) or subjective (such as self-reports, questionnaires, or interviews).
Benefits of Clinical Trials
Clinical trials are essential for advancing medical knowledge and finding new treatments for conditions such as Alzheimer’s disease. They can benefit the participants as well as the public in several ways:
- Participants may have access to new treatments that are not yet available to the public, and that may improve their symptoms or slow down the progression of the disease.
- Participants may receive additional attention and care from the research team and have the opportunity to learn more about their condition and how to manage it.
- Participants may contribute to scientific discoveries and help other people who have the same condition or who are at risk of developing it in the future.
- Clinical research trials can lead to the development of new drugs, devices, or interventions that can improve the health and well-being of millions of people.
Join Our Research Efforts for Alzheimer’s Disease
The Frank C. And Lynn Scaduto MIND Institute at Miami Jewish Health is a leading clinical research site for the latest treatments for Alzheimer’s disease. As part of our mission to find a cure, we maintain strong affiliations with esteemed medical institutions and leading pharmaceutical companies to drive progress in Alzheimer’s disease research.
Under the visionary leadership of Dr. Marc E. Agronin – nationally recognized expert on Alzheimer’s disease, memory disorders and geriatric psychiatry – our clinical research trials employ the latest methodologies and are guided by the most promising theories in the field.
If you or a loved one are interested in participating in or learning more about our Alzheimer’s clinical research trials, call us at 305.514.8710 for more information.