A clinical trial is a well-planned research study to determine if a new health care practice, medicine, device, or procedure is safe and effective when used by human volunteers. All treatments must undergo rigorous clinical research to ensure they are effective before they can be used on patients, and that they are more beneficial than harmful. The first step to making an informed health care choice is to understand what a clinical trial is.
In the absence of clinical trials, modern medicine would be stagnant. All the vaccines, cancer treatments, and approved medicines used today have undergone carefully designed clinical trials. Such trials safeguard patients from accessing treatments that may not be effective, as well as provide dependable, peer-reviewed scientific evidence to drive progress. A trial can also provide patients with access to new and innovative treatments before they are available to the general public.
The various stages in a clinical trial are the carefully planned stages needed for regulators to approve any treatment. Let's take a look at each phase:
Phase I trials are conducted with a small number of volunteers (20 to 80 people) to determine the safety of the medicine, identify side effects, and establish safe dosage ranges. It's the first time the treatment is tested on humans.
In Phase II, further testing is conducted in a larger group (up to several hundred participants) to evaluate effectiveness and safety. Researchers ask, "Does the treatment have the desired effect?”
In Phase III, the treatment is compared with the standard care used at the time by thousands of patients. This is why a placebo is typically used in clinical trials, as some receive the treatment and others get an inactive placebo to generate unbiased trial results.
If approved, the drug will enter Phase IV trials. They follow real-world results for all people over months or years and look for uncommon side effects and long-term effectiveness.
Inclusion or exclusion criteria are conditions that a person must meet (or not meet) in order to be accepted for a clinical trial. These criteria are based on age, medical history, diagnosis and medications. They provide the safety of participants and ensure the data collected from the study is accurate. There is no absolute contraindication to participating in a Phase I study, except that the subject is ill enough to require hospitalisation and cannot be moved to the hospital. Many healthy volunteers participate in Phase I studies. Determine if you qualify for a trial as soon as possible.
Myth: I will definitely receive a placebo and get no real treatment.
Fact: In many trials, even the placebo group is given the current standard of care.
Myth: Clinical trials are a desperate measure.
Fact: Health trials are open at every stage and being a trial participant could be a way of having access to tomorrow's treatments today.
Myth: My information is not secure.
Fact: Any clinical study has to follow strict ethical and regulatory guidelines to ensure patient confidentiality.
It can be overwhelming to navigate thousands of active clinical trial studies, trying to find the right one for you. At Clinrol, our recruitment and engagement platforms are driven by AI to match you with the most relevant clinical trials, based on your health characteristics and clinical trial eligibility. We connect you with new treatment options and research sites so you can contribute to a trial that best suits you.
Find a clinical trial near you: https://www.clinrol.com/study
Sources & Further Reading
Clinrol. AI Clinical Trial Recruitment & Engagement Platform. clinrol.com
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