What are Clinical Trials? Exploring the World of Clinical Research
Updated: Aug 17
You’ve heard of clinical trials before, but you probably don’t have a clear understanding of them. So what are clinical trials? These are research studies that are performed in people, to assess specific medical, surgical, or behavioral interventions. Clinical trials represent one aspect of clinical research; the other is observational studies. These studies observe people in their everyday lives and collect information via medical exams and surveys to make assessments to improve their health and welfare.
We’ll explore several aspects of clinical trials. We’ll consider the importance of trials, the phases of a clinical trial, how you can participate in a trial, and important questions that you should ask before signing up for a clinical trial. Let’s get started!
What is Meant by Clinical Trials
Clinical trials facilitate a realistic overview of a range of medical interventions. These trials are often the best way for medical researchers to discover if a new treatment option (like a new drug or medical device) is beneficial and safe for human use.
All clinical trials in the USA require approval from the Food and Drug Administration (FDA) before they can begin. Scientists also first conduct lab tests and studies in animals to assess a potential therapy’s safety. If there are no adverse results in these animal studies, the FDA may approve its use in humans.
Why are Clinical Trials Important?
Clinical trials are critical in advancing how we care for diseases through medical interventions. They may focus on early disease detection (especially before symptoms emerge) to help people access a treatment sooner rather than later.
Other clinical trials may also seek to prevent disease, or help people live more functionally with chronic or life-threatening illnesses. Some clinical trials may also help caregivers in their support roles.
The Anatomy of a Clinical Trial: Exploring the Phases
Clinical trials go through four stages to test each intervention, discover the correct dosage, and also identify side effects. If a medical intervention passes the first three stages, the FDA can clear it for clinical use as any side effects are continuously monitored.
A Phase I clinical trial tests an experimental treatment on a small group of people. This group may range from 20 to 80 healthy persons to assess its safety, identify any side effects, and find the appropriate drug dosage.
This stage increases the number of people in the trial (generally 100 to 300). The emphasis switches the safety analysis in Phase I, to assessing the effectiveness of the medical treatment.
A Phase II clinical trial seeks to gather preliminary data on whether or not a drug helps people with specific medical conditions. These trials will still consider the short-term side effects of the intervention. It should also be noted that a Phase II trial can last for several years.
Once a clinical trial gets to Phase III, it’s possible to gather more information regarding:
Safety and effectiveness of the medical intervention
Use of the drug or device in various populations and a range of dosages
Drug’s or device’s interactions with other medical treatments
A Phase III trial has an even larger number of participants ranging from several hundred to approximately 3000 participants. The larger sample size allows more reliable and detailed conclusions to be drawn from the clinical trial.
The FDA also assesses the results of the clinical trial at this stage. If they are positive, the medical intervention can be approved for experimental use.
In Phase IV the drug or device is evaluated for its effectiveness and safety in larger and more diverse populations. At this stage, any small effects of the treatment become more apparent as more people would have used it over a longer period.
Why You Should Participate in a Clinical Trial?
Concerns That You May Have
Managing the symptoms of chronic illness and your existing treatments are challenging. You may have misgivings about joining a clinical trial such as:
Not wanting to feel like a random patient in an impersonal experiment
Getting an ineffective, or even harmful treatment
These are valid concerns as clinical trials have risks and benefits. At Insight Clinical Trials, we take the time to explain the details of our trials to each participant and their families. You will be clear on how trials work and the reasons why you should become a volunteer in a trial that best suits your health needs.
Some Benefits of Joining a Clinical Trial
You may choose to join a clinical trial because you are in search of the latest and most effective treatment. Even if you are not suffering from an illness, participating in a trial can help you discover how to prevent hereditary medical conditions.
Let’s explore a few of the advantages of joining a clinical trial:
Taking control of your healthcare: Participating in a clinical trial puts you in the driver’s seat of your health and treatment options. All of our Insights Clinical Trials are free of cost to our patients and their families. You also don’t need to have health insurance coverage. Some of our studies last for several months, so you could have long-term healthcare for your condition over the duration of your particular trial.
First-in-line access to innovative medical interventions: As a trial participant you get access to potential treatments before they are made available to the public. Furthermore, all new medications and devices must pass the FDA’s strict standards before being used on trial participants. So you’ll be among the first to access these latest medical treatments.
The best healthcare in excellent facilities: Clinical trials are run by the leading medical experts and you will benefit from their years of expertise. Plus, your clinical trial will have the benefit of the most up-to-date medical tools.
Support a worthy cause and assist future generations: Participating in these important medical research studies is not just about your health. It’s all about paying it forward to the next generation’s healthcare. As a clinical trial participant, you assist in developing the best medical treatments to improve the quality of many lives in the future.
Become a ray of hope: You can save the day for those suffering from severe health problems, so you can help researchers prevent and treat such medical conditions. It doesn’t matter if your specific trial doesn’t result in a wonder drug or treatment. Your participation helps us get a step closer to a life-changing medical discovery.
Compensation: Clinical trials are usually of no cost to you. You may even receive monetary compensation for your participation in a trial. Other trials may provide some reimbursement, medical equipment and/or medication.
What to Expect in a Clinical Trial
Joining a clinical trial sounds a lot more complicated than it is in reality. Here’s a quick checklist of what you can expect:
Our staff will explain the trial in detail and also gather your medical and personal history.
After sharing all the trial’s details, and we’ve answered all your questions, then you would agree to participate in the trial. The next step is to sign an informed consent form.
You undergo medical screening to ensure that you qualify for the clinical trial.
If you’re accepted into the trial, it’s time to celebrate! You’ll also have to schedule your first, also known as your “baseline” visit. Medical researchers perform cognitive and/or physical tests during this initial visit.
You are then randomly assigned to a treatment group or a control group. The treatment group will receive the actual medication, while the control group receives a placebo. Even if you are in the placebo group, you will still provide valuable insights into the medical research processes.
You, your family, and/or caregiver(s) will follow the clinical trial’s procedures. Feel free to direct your issues or concerns at any time to our medical researchers.
As a trial participant, you’ll need to visit the research site at frequently scheduled times. In these visits, you will complete new cognitive, physical, or other evaluations, and also have the chance to speak with our medical staff. At Insights Clinical Trials, your holistic wellbeing is our priority.
For the duration of the trial, you will keep seeing your usual physician for your customary healthcare.
How Do I Find a Clinical Trial?
There are several ways to find a clinical trial. Your doctor or healthcare provider is a great resource for information. You may also search the ClinicalTrials website.
As well, you can sign up for a registry to connect you with clinical trials that are close to you. Are you a part of a support group for your condition? Then they may also have lists of clinical trials that you can consider joining. Some clinical trials may also advertise in your local newspaper or on TV.
You can visit our website to see what clinical trials are currently open for recruitment.
What Is the Next Step After I Find a Clinical Trial?
Once you’ve located a clinical trial that you would like to join, you need to contact the coordinator for that study.
This information can be found in the description of the clinical study. As we discussed before, the first step is a screening appointment to see if you qualify to join the trial. You will also get the chance to learn more details about the study.
However, don’t leave your regular physician in the dark! You need to meet with your doctor to discuss joining a clinical trial. He or she may want to speak with the study’s research team to ensure that the study is safe for you. Your doctor may also want to get regular updates about your progress while you’re in the clinical trial.
Choosing Clinical Trial Participants
We’re sure that you would like to know how researchers choose participants for their clinical studies.
After you consent to join a clinical trial, the results of your medical screening will determine if you meet the trial’s participation criteria. Please note that this screening may also include cognitive and physical tests.
Some examples of inclusion criteria are:
Stage of the medical condition
Possible interactions with medications being taken
Having someone (a study partner) to help you get to and from the research center throughout the trial
Clinical trials often screen more participants than they require for the study, as this assures them of having sufficient volunteers.
If you’re excluded from a trial, it doesn’t mean that you may not qualify for another. Each clinical trial has unique inclusion criteria, so keep trying to sign up!
The Importance of Diversity in Clinical Trials
Clinical trials need to have diversity in their pool of participants. Having a variety of ages, sexes, races, and ethnicities ensures that the study’s results are more applicable to the wider population.
Older participants are quite helpful in clinical trials since researchers can gain more insights into how new medications, devices, procedures, and tests will work for that group of individuals. Most older people have unique health requirements that a younger demographic does not. For example, older people will need different and lower drug dosages to have the desired results. They may also develop special side effects. Therefore, having older participants will assist scientists in getting the data they need to create the best treatment for this group.
It may be difficult for some older adults to join a clinical study. They tend to have several health problems at once that are all being medicated. That makes it harder to isolate a specific condition in the trial.
Another consideration is that older groups tend to be frailer and may also have a disability which would hinder their ability to participate. Many older people may also not have a study partner to accompany them to and from the study site for the clinical trial.
However, these challenges do not exclude older individuals from participating in clinical trials. It just means that you will have to discuss these concerns with the clinical trial coordinator. Chances are, there may be some alternate arrangements that could be put in place to facilitate participation in your clinical study of choice.
The End of a Clinical Trial: Next Steps
At the end of a clinical trial, the scientists will collect and analyze the data to see what the results indicate.
At the start of the study, you would have been told about its duration, what support you would get (if any) after the study ends, and if you would receive the results of the study.
Therefore, you need to get as much information as possible about the period after the study at the time you’re signing up.
Questions You Should Ask Before Joining a Clinical Trial
Participating in a clinical trial requires much preparation. You need to be ready to ask the research team as many questions as you can. This will help you to figure out if a clinical study is right for you. Take along this list of questions to help you in your assessment:
What is this study trying to discover?
What treatment or tests will I be able to access? Are these painful?
Will I get any test or lab results?
What are the chances that I will be chosen for the experimental treatment or the placebo?
What are the possible risks, side effects, and benefits of the study treatment compared with my current treatment plan?
How would I know if the treatment is helping me?
What is the duration of this clinical trial?
Where will the study occur?
Will I need to be hospitalized?
Will you provide assistance for me to get to the study site (like a rideshare service) if I need it?
Can I do any part of the trial with my family physician? Is there a clinical trial that’s located closer to me?
How will my participation in this study affect my daily life?
How will this study protect my privacy?
How will you support my health while I am in the study?
What happens if my health condition worsens during the clinical trial?
Can I take my regular medication while participating in this trial?
Who will be in charge of my care while I am in the study?
Will I be allowed to see my family doctor?
How will you keep my doctor updated about my participation in the trial?
If I withdraw, will this affect my usual healthcare?
Participation Costs and Reimbursement Mechanism
Will I need to pay to participate in this study?
If I need to pay any costs (such as travel, parking, or accommodation), will I be reimbursed?
Will my insurance pay for costs not covered by this clinical trial?
Will I need to make any out-of-pocket payments?
Can I join this study if I have no insurance?
Will I need a study partner? If so, how long will he or she need to participate?
Will the clinical trial compensate my study partner for his or her time?
After the Trial
Will you follow up with me about the state of my health after the trial ends?
If so, what is the nature of that support (medication, checkups, etc.)?
Will you inform me about the results of the study?
Who would I call if I have further questions after the clinical trial ends?
Contact Insight Clinical Trials
Hopefully, that question we started with, “what are clinical trials?” is now clarified. Knowing the advantages of participating in a clinical trial and the strict regulations surrounding them should help you feel more confident about joining a study.
Insight Clinical Trials is one of the leading independent medical research institutes in Northern Ohio. We specialize in clinical research and treatment involving pain, headache, Alzheimer’s, and other neuropsychiatric disorders. Our team of medical experts stands ready to help you access the latest medical interventions and healthcare. Contact us today to learn more about what clinical trials are and any questions you may have about them.