Clinical Trials. You’ve probably come across the term while watching the news or scrolling through social media. Clinical trials are now enrolling, the ads on Facebook might say.
But what are they?
In the past, we have associated clinical trials to mad scientist and guinea pigs. However, this is a huge misconception. Clinical trials are completely voluntary and may resemble a regular visit at your physician’s office.
Here’s how they work:
All clinical trials are led by a Principal Investigator or PI. Often, the principal investigator will be a doctor. The PI and the research team will follow a protocol which details the steps of the trial, its purpose and all key factors the team has to know to conduct the clinical trial. Some of the information you can find in a protocol are the number of patients that will participate in the trial, eligibility criteria, what tests are needed from the patient, the data that needs to be collected and detailed information about the treatment plan.
The protocol exists to assure that all clinical sites, which can be located all around the country or the world, conduct the trial in the same way and collect and document the same information.
The goal of clinical trials is to assess the safety, effectiveness, and tolerability of a treatment, medication or device. They aim to understand how a certain treatment works and if it can be of benefit to certain populations (i.e., people with a chronic disease).
With that goal in mind, the investigation of a specific medicine or treatment is divided into four phases:
- Phase 1: Healthy volunteers are recruited to help test how the medication or treatment interacts with a healthy body.
- Phase 2: Primarily, the safety and side effects of the treatment are tested along with evaluations of effectiveness with volunteers who have the condition for which the treatment is designed to treat.
- Phase 3: More extensive testing is conducted to assess effectiveness and safety in much larger numbers of volunteers who have the condition for which the treatment is designed to treat.
- Phase 4: The treatment or medication is further tested after FDA approval to be used by the general public. Phase 4 studies often look at secondary treatment options or additional populations such as pediatric volunteers.
Who sponsors the trials?
Often, clinical trials are sponsored by the pharmaceutical company that’s developing the drug. Protocols are developed with the input of the FDA and must be reviewed and approved by independent ethical review boards.
Why are review boards needed?
Ethical review boards also known as Institutional Review Boards (IRB) have the sole purpose of protecting human subjects that join a clinical trial. Their sole purpose is to help ensure that all participants are treated ethically and protected throughout the clinical trial process. IRBs are made up of several local officials that are unbiased and offer different perspectives to help ensure that subject safety and ethics are maintained at all times during the study.
Why join a clinical trial?
Clinical trials provide volunteers with access to medical professionals, doctors, tests and education about their conditions and potentially more. A clinical trial may offer you a potential new treatment option for your condition at no cost and may help you gain a better understanding of your overall health. Additionally, some clinical trials test a new treatment option against treatments that are already on the market. So, you may receive treatment with an approved treatment option.
Joining a clinical trial is completely voluntary and if at any point you are not comfortable with it, you can leave the trial.
Finally, you don’t need insurance to participate and most clinical trials will compensate you for your time and travel.
If you are interested in learning more about clinical trials, click HERE.