Do you know how medicines are tested to ensure safety and effectiveness? Through clinical trials! We know that many people have not heard of clinical trials, and those who have, may not know what happens in a trial. So, we here at MindMate have have gathered all the information you need to know about clinical trials.
What is a clinical trial?
Before clinical trials, experienced doctors simply passed on their knowledge to more inexperienced doctors. This approach came bearing many risks and was fairly dangerous for the patient. Due to this, a safer, more standardized way was developed to test new treatments, drugs, medical devices, and procedures: clinical trials! Clinical trials make sure that the medical care a patient receives is safe and effective. Without clinical trials, there would be no innovation in the medical field.
Clinical trials need volunteers to try new treatment options. Once these volunteers have been found, researchers then collect data to see how they respond to the new treatment options. Sometimes clinical trials involve testing new treatments and other times they test already approved treatment options for different conditions.
Quick Facts you should know about Clinical Trials
Healthy individuals and individuals living with health conditions are great candidates for clinical trials. In some studies it is important to compare research data from healthy individuals to individuals with a specific health condition.
Clinical trials can test various medical interventions, which include drugs or devices and medical procedures.
Clinical trials are on a voluntary basis; no one can force you to participate in a clinical trial, and you can stop participating at any time.
Clinical trials are highly regulated by the FDA and monitored by groups that include doctors, researchers and community members
What kind of clinical trials exist?
There are different kinds of clinical trials that always depend on the initial goal of the trial.
Randomized trials
In a randomized clinical trial, the patient is assigned to one of two or more treatments by chance, but the patient gets the treatment option and cannot get a placebo. Neither the patient nor the care team can choose which treatment the patient actually gets. Nevertheless, each patient receives the same care. As the trial goes on, the results of the different treatments are closely watched and compared.
Single- or double-blind studies
The difference between these two studies is fairly simple: in a single-blind study, patients don't know which treatment they are getting, but the care team does. In a double-blind study, nobody knows which treatment is being used: neither the patients nor the care team. However, it is possible to find out which treatment the patient is receiving, should there be the need to do so.
Placebo-controlled studies
Placebo-controlled studies are the only trials in which a placebo is used! A placebo looks like the real medicine but doesn't contain any active ingredients. In this kind of trial, some patients will get the real medicine, and others will get the placebo. An important thing to remember: you will not know which one you get. The placebo acts as a control, allowing researchers to assess whether the medicine creates any beneficial effect or not.
Observational trials
Patients in an observational trial may be compared to patients that are being treated in a different time or place. They receive the same care or treatment as all other patients. In such trials, doctors tend to observe and record how patients do over time.
Categories of clinical trials
Clinical trials are categorized based on the research questions they are looking to answer. This can be:
Prevention trials: As the name suggests, prevention trials are looking into preventing a disease. Usually, researchers are looking for people who have never had the disease or for people who want to prevent the disease from returning. Lifestyle changes, vaccines, or new drugs are approaches to this type of trial study.
Quality of life trial: This trial approaches people with chronic conditions and aims to improve their comfort and quality of life in different ways.
Treatment trials: In this trial, new treatments, new approaches to surgery, or a new combination of drugs are tested.
Screening trials: are testing new ways to detect health conditions or diseases.
Behavioural trials: look into how behavioral changes can improve health.
Diagnostic trials: compare tests or procedures for diagnosing a specific disease or health condition.
The different phases of clinical trials
Clinical trials go through different phases in order to test the safety of these treatments, which side effects a drug could have and how effective these treatments are to certain group:
Phase I is an experimental treatment on a few people (usually 20-50) to learn more about a new drug’s side effects and to find the right dosage.
Phase II deals with the effectiveness of a treatment and aims to find out if the new drug or treatment works in certain risk groups with different health conditions.
In phase III, researchers collect more information on the effectiveness and safety, while testing different people with different backgrounds for the dosages of the treatment while also combining the drug with other drugs.
In the final phase IV, the treatment has already been approved by the FDA. This phase aims to further monitor the safety and effectiveness of the new drug in a large and diverse population.
10 Reasons why to participate in clinical trials
Now that you have learned more about clinical trials, here are 10 reasons why people participate in clinical trials:
Ability to access the latest treatment options or drugs, otherwise unavailable to the public
Help find a cure and make a difference for millions of people living with health conditions
Live better
Help discover medical breakthroughs
Access to new medications at a lower cost or for free
Access to better care: focused clinical care teams (nurses and doctors) available 24/7 and free of charge
Live longer
Hope for better outcomes
You get reimbursed for travel and taking the time to be part of a clinical trial.
Clinical trials need participants from all backgrounds, so all ages, races, and genders - clinical trials need you!
Want to learn more about clinical trials or sign up for one and make a difference for the health community? Click here.
Alzheimer’s Clinical Trials
Currently, around 100 clinical trials are being planned and/or conducted in the United States in regard to memory loss, Alzheimer’s disease, and dementia.
One example, that can not only drive Alzheimer’s research forward, but can have a significant impact on the 5 Million people in the US living with Alzheimer’s Disease was started in 2011. There was a Phase 1 clinical trial to study the effects and safety of a medication, Aducanumab, for Alzheimer’s Disease patients. This randomized, double-blinded, placebo-controlled clinical trial enrolled 53 participants, and at the time these participants were the only ones able to have access to this medication. This clinical trial paved the way for further research and development, and today this medication is currently in Phase 3 clinical trials as a potential medication in the treatment of Alzheimer’s Disease. To find out more, visit: https://www.alz.org/news/2019/alzheimer-s-association-statement-biogen-report-of
