What is a clinical trial?
In order to understand what a clinical trial is, one must understand how medications are developed. Pharmaceutical companies employ teams of scientists to develop and research new compounds to treat an array of diseases and conditions. After the initial laboratory testing is complete and the new compound has passed preliminary safety and efficacy testing in the lab, the pharmaceutical company files an application to the FDA to begin Phase I clinical trials. The average time a new medication takes from the beginning of a Phase I trial to FDA approval is approximately 12 to 14 years.
A clinical trial is the process by which pharmaceutical companies test the safety and efficacy of new medications. There are four phases to every clinical trial:
The new medication is given to healthy individuals who do not have the condition the new medication is intended to treat. These are usually small studies, fewer than 100 patients. This is also the phase in which the initial safety data gets collected.
This is the phase when the new medication is first introduced to patients who have the condition the medication is intended to treat, and also when preliminary efficacy data is collected. During this phase safety data continues to be collected, and changes to dosages are made.
This is the last phase before a medication is presented to the FDA for approval. Phase III clinical trials are usually large trials that often enroll thousands of patients in several states and even in other countries. This phase is also when efficacy and safety of the medication are established.
Also called “after-market trials,” these trials are conducted after a medication has received FDA approval and is available to the public. FDA requires pharmaceutical companies to continue monitoring their medications even after they have received approval.
Why are clinical trials important?
Clinical trials are important because they are the only vehicle by which any medication will ever become available to the general public. Every single medication, whether it is over the counter or available by prescription, must go through the clinical trial process. But perhaps the best way to describe the importance of clinical trials is by asking the following question: Have you ever taken a medication to treat any condition? If you answer “yes,” then you should thank the thousands of participants who volunteer for clinical trials so that medications become available to the rest of us.
What can I expect from a clinical trial?
The process of participating in a clinical trial depends on the type of research being conducted. A team, also known as site staff, for a given clinical trial might include doctors, nurses, social workers and other specialized health care professionals. The role of the site staff is to check your health at the beginning of the clinical trial, provide specific instructions and guidance for what to do during the trial, watch over your health throughout the trial and make sure that the study is followed.
Based on your condition, some clinical trials involve more diagnostic tests and doctor visits than you might initially expect. The tests and visits help the site staff ensure that your health and safety are monitored carefully.
How to Become a Clinical Trial Participant?
If you are interested in being considered for clinical trial opportunities, follow the simple steps below to register:
- Complete the clinical trial participant form at one of our 4 clinics to add your name to our database of potential study participants.
- If you filled out the form and are registered in our database, a member of the study staff will contact you when a clinical trial matching your criteria (based on the information you provided) is enrolling participants.
- If you are interested in participating in clinical trials, you will go through a pre-screening process to make sure you qualify for the trial. This usually involves a series of questions related to your health, the medications you take and possibly your lifestyle.
- If, after pre-screening, you are determined to be eligible to participate in the clinical trial, the site staff conducting the trial will provide you more details about your participation and answer any questions you may have. They will also ask you to review and sign an informed consent document.
Required Physical Exams, Medical Assessments and Tests
To determine if you meet all of the requirements for a clinical trial, a physical examination is usually conducted during the screening process. This exam may include:
- Measurement of your height, weight, temperature and blood pressure
- A test that records the electrical activity of your heart, known as an electrocardiogram
- Blood and/or urine samples
- Other diagnostic tests such a CT scan or MRI as required by the clinical trial protocol
All of the information obtained during the screening process is kept secure. If you qualify for the clinical trial, you will be contacted by the site staff to schedule any trial-related clinic visits and discuss your participation in more detail. Your participation is completely voluntary. So, even if you decide to enroll in a clinical trial, you are free to leave the trial at any time, for any reason