We are beginning a clinical study, an important step to show the value of our digital health solution and allow us to get firsthand user insight to improve the product. In preparing for this, it has become apparent to us that many people don’t understand what a clinical study is, why these studies are important, and how they can participate. We have put together the information in this post to help answer some of these questions.
What is a clinical study?
The National Institutes of Health (NIH) defines it this way:
“Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making.”
Now let’s discuss in more detail.
Why are clinical studies important?
Medical technologies and treatments are evolving rapidly, yet without clinical studies it isn’t possible to know for sure whether a specific treatment is better than another. It is also necessary to understand the limitations of treatments or diagnostic tools.
There have been unfortunate cases in the past where new medications or treatments became common without first being thoroughly evaluated in trials. Later, clinical trials revealed these things were actually harmful to patients. This has been seen a few times in treatment of patients with heart failure. This demonstrates that it is important to carefully study new interventions and treatments with a clinical study to understand the benefit and risks.
How do clinical studies work?
There are many types of studies, and each type works differently. Two of the most common are a randomized control trial and cohort study.
· Randomized Control Trial - In this study, there are at least two groups and after a participant consents to be part of the study, they are randomly assigned into one of the groups. One group may be getting a treatment or therapy, such as a new medication or a tool to use, and the other group may simply continue their current care. Both groups will likely be monitored, whether by surveys or other measurements, to see if there are different results between the two groups. This type of study is important to know whether something new will actually help improve outcomes.
· Cohort Study – This type of study (also called a prospective observational study) has two different groups of people that are being monitored over time. One group has a particular condition or received a specific exposure in the past and the participants in the other group don’t have that condition or did not receive the exposure. By following these two groups of participants over time and tracking differences, much can be learned about the effect of a disease or exposure.
Are there rules that clinical studies need to follow?
Yes, there are many rules that clinical studies need to adhere to. Clinical study rules were made to create standards that protect patients and help produce reliable study results. For example, one rule is that each study needs to be reviewed by a board of experts (the Institutional Review Board, or IRB) to ensure the study is protecting the welfare of the participants and is properly informing them of the risks and benefits. So before a study is launched, a significant amount of effort is needed to ensure the study overall meets a strict set standards.
Who can participate?
This answer varies for each specific clinical study. When the trial is designed it is decided what group of people is going to be studied. There is often a restriction on age and medical condition. There can also be additional requirements that vary from location of the individual, what medications are being taken, to how severe the condition. There are usually screening questions to determine eligibility before you can consent for a clinical trial.
Where can I find a clinical trial that I can participate in?
There are many different ways to find clinical trials and potentially participate.
· ClinicalTrials.gov - is sponsored by the NIH and is a place where clinical studies all around the world can be registered. You can search by specific condition and country. For example if you are looking for a study for your child with asthma.
· Centerwatch - has trial listings and will allow you to sign up for e-mail notifications for new trials that you may be eligible for.
· Local medical centers – local centers often have a list of studies that are being run at their location.
· Groups for specific medical conditions may also have lists of current trials.
Choosing to participate in a clinical trial can be a big decision and should be made very carefully, but given the importance of these studies for the progress of medical science, if you do choose to participate in one you can do so knowing that you’re indirectly helping many other people.
Let us know if you have any additional questions, e-mail us at firstname.lastname@example.org.