What is a clinical trial and why should I participate?
Before clinical trials, experienced doctors simply passed on their knowledge to more inexperienced doctors. As you can imagine, this approach came bearing many risks and was fairly dangerous for the patient. Due to this, a safer, more standardized way was born in order 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.
To do so, clinical trials need volunteers to try (new) treatments. Researchers then collect data from volunteers who participate in clinical trials to see how well a (new) treatment works. We put new in parentheses because sometimes even older procedures are tested against new ones to see if the new ones are really better than the older ones.
The first recorded clinical trial was held in 1747 by Lames Lind who wanted to find out if citrus fruits, like lemons and oranges, can help sailors with scurvy. This is also from where Citruslabs got its name - in honor of the first recorded clinical trial in history!
Many individuals join clinical trials because
They want to help modern medicine to find better ways to detect, diagnose, control, treat, and prevent illnesses.
They grasp the opportunity to potentially improve their health.
Especially in the US, where healthcare can be a huge cost factor, clinical trials may also be a good way to get treatment in a cost-effective way. Important to remember: no one can force you to participate in a clinical trial and you can stop taking part in a clinical trial at any time.
Clinical trials come in different shapes and sizes and you should know what you’re getting into. First, you need to know about the phase of the clinical trial you are about to join:
Phase I: This is an experimental treatment on a small number of people (usually 20-50) to learn more about a drug’s side effects and safety and also to find the correct dosage.
Phase II: This phase is all about effectiveness and aims to find out if the new drug or treatment works in people with a certain health condition.
Phase III: This is a trial on a larger scale. Typically, about 500-3,000 people are involved and can last several years. The aim of this phase is to collect more information on effectiveness and safety while studying different demographics and populations with different dosages, also combining the drug with other drugs. If the result of Phase III is positive, the FDA usually agrees to approve the drug.
Phase IV: This phase happens after the FDA has approved the drug and aims to further monitor the safety and effectiveness of the new drug in a large, diverse population.
Apart from the phases, there are different ways how to conduct a clinical trial:
Often, patients are concerned that they might get a placebo. In a randomized clinical trial, the patient is assigned to one of two or more treatments by chance, but, the patient gets treatment 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 and if one group does much better than the other, the trial may be even stopped early.
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 are the only trials in which a placebo is used! A placebo looks like real medicine but doesn't actually contain the medicine. 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 real medicine or the placebo. The placebo gives the researchers the opportunity to see if a new drug that is being tested actually has a better effect than the usual medicine, or has even no effect at all!
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. What usually happens in an observational trial is that doctors observe and record how patients do over time.
Apart from that, there are also different types of clinical trials:
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.
Behavioral trials look into how behavioral changes can improve health.
Diagnostic trials: Diagnostic trials compare tests or procedures for diagnosing a specific disease or health condition.
Now that you gained some insights into clinical trials, why not learn even more and sign up for one? Just visit click on the link that says “sign up” below. Important: this does not automatically match you to a clinical study!
Reasons for participating in a clinical trial:
You can be one of the first individuals who get to try a new treatment or drug.
You may have access to potentially life-saving treatments earlier than everyone else.
You will receive care from a dedicated team of health professionals who are interested in your health.
Help modern medicine to understand whether a new treatment or drug works better, or even has risks compared to current treatments or drugs.