Welcome to our in-depth guide on clinical trials and their crucial role in advancing medical science.
In this article, we’ll explore the world of clinical trials, from their vital contributions to society to the intricacies of the clinical trial process.
What are clinical trials?
Clinical Trials are the way that new and innovative methods of treatment are investigated. Trials are a form of research study that are vital for improving medical treatments, saving lives, and enhancing overall quality of life.
When a scientist thinks of a new cure or a drug, we have to be absolutely sure that giving it to people will be safe, and that it will help. Modern testing is guided by a well developed and strict code of ethics that must be followed to reduce harm.
When testing on humans researchers divide their volunteers into groups called “arms”.
One group will receive the study drug, and the other will receive a placebo. A placebo is not a real drug, and we use computers to randomly choose who will receive the real drug and who will not.
It’s important to use placebos because when we think we have taken something our belief can change the way we experience things.
Contributions of Clinical Trials
The contributions of clinical research have changed our quality of life more than we realize, and we should be immensely grateful for them.
Modern clinical trials are strictly regulated and highly scientific, using brand new techniques and technologies to produce inspiring treatments that will highly improve the lives of billions of people.
Covering all of the contributions of clinical trials would be a massive undertaking, but it isn’t hard to look at it with a broad view.
- Commonly used medicines such as aspirin, cough syrups, or nutritional supplements.
- All vaccines.
- Medications for heart disease, or cholesterol.
- Chemotherapy drugs.
- Antidepressants and anti-psychosis drugs.
- ADHD medications
- Insulin, for diabetics.
- Antibiotics, for infections.
- Antiviral drugs.
The list is endless and always growing.
Process of Clinical Trials
Clinical Trials move through a series of phases, and each phase has objectives that must be met to move to the next.
This separated series of tests ensures the validity of results, which means we can confidently say which drugs are safe to distribute.
Clinical Trials start with pre-testing design, then move to pre-clinical testing.
After that, once it is believed that the drugs are safe to try on humans, we go through four separate phases of human testing protocol. Let’s take a closer look starting at Pre-Testing Study Design.
Pre-Testing Study Design
Before anything else, scientists need to create a plan for how they will test a new drug. They answer questions like:
- How can we see if the drug works?
- How can we see if patients become ill?
- What will we do if something bad does happen?
- How many people need to see results to say the drug works?
And many more.
This is where the trial is logically structured so that testing is valid and safe.
Preclinical Testing
Before testing on humans, scientists first perform laboratory experiments using artificial intelligence (A.I.) to examine molecular data for insights.
Then they proceed to animal testing to assess the medication’s safety and effectiveness. Animal testing is important to reveal side effects that might occur on humans.
Phase 1
This is where clinical researchers start to test on humans, usually with a participant pool of 20-100 people. What they are looking to find out is how much of a dose to give, and what side effects occur.
Trials are typically conducted on a small, specifically healthy set of subjects to reduce the likelihood of harm.
Once the drug has been shown to be safe enough to continue testing it can proceed to phase 2.
Phase 2
In this phase, researchers expand the pool of test subjects to around 100-500 participants. The primary focus is dosage and effectiveness, similar to phase 1.
By testing on more subjects, scientists can search for rare side effects and events. Knowing about how the drug interacts with a larger population helps develop confidence in its safety. We learn about how well the treatment works, and what doses are well tolerated.
Phase 3
It can take four to five years to reach phase 3 trials.
This part of the study consist of a large and diverse pool of participants. Treatments work differently for people depending on gender, age, race, sex, and ethnicity.
Researchers are trying to measure the new treatment against the treatment that is currently available.
The pool of subjects goes over 500 participants, to be certain that it is safe to prescribe for patients. If everything goes well in this phase, and the drug is proven to be better than the alternative, the developer will apply for regulatory approval.
Phase 4
After the drug is approved by regulators such as the Food and Drug Administration (F.D.A), doctors can begin prescribing it to patients.
In previous phases the doctors administer the drug, but by now, the patient can go and see a pharmacist to pick it up.
The drug is closely monitored for safety as it is released into the market. All of this testing is thorough and takes many years, but it’s the only way to verify if releasing a medication is a good idea.
Why do people participate in clinical trials?
- Helping researchers develop better treatments for everyone.
- Contributing to medical understanding of diseases for future generations.
- Potential to gain access to treatments that could relieve symptoms.
Are there risks associated with clinical trials?
Certainly.
This is why there is such a rule-based process to testing these drugs. It’s all about safety.
Any medication that’s in a clinical trial is being tested for its safety. Usually by phase 2 it’s been tested on 20-100 people, and it’s been determined to have a low likelihood of being dangerous.
However, the medication may cause uncomfortable side effects, and in some cases they may be serious.
There is a risk that the medication might simply not work for you or that previous medications could be better.
You could also be selected to be part of the placebo group and no one would know; and if this is the case you might consider the trial a waste of time.
But, your contribution can help future generations to have better options, potentially even cures.
What does Simcoderm Clinical Trials do?
Simcoderm Clinical Trials has run over 75 clinical trials to date, working on creating new treatments for skin conditions. Simcoderm Clinical Trials is a department of Simcoderm Medical & Surgical Dermatology Center, where we diagnose and treat conditions like skin cancer, eczema, vitiligo, psoriasis, H.S., and many more.
Because of our dermatology focused expertise, and our operational capabilities, we are often chosen to be the first to test new treatments in Canada and at times the world.
We only run phase 2 and 3 clinical trials.
Trials start with a screening period where we check on the health of our volunteers to make sure there is a reasonable level of safety in letting them in the trial.
After that is the treatment period where we administer the drug and monitor its concentration in the body. Here we watch for side effects and the effectiveness of the drug.
The trial ends with a follow up period where we check on your health and collect further information about your experience.
It is our hope and belief that through research we can find far more effective treatments for skin conditions that will massively improve the lives of many people. There are several promising drugs in testing right now that we are helping to develop.
If you want to participate in any of our clinical trials click here or call us at 647-202-6393.
