A clinical trial is a research study involving human subjects. They are performed to show whether a drug is safe and effective for a particular diagnosis when prior approved treatment options are either not working or yield unwanted side effects.
Clinical trials differ from routine medical care because they have a specific goal to determine the effectiveness of the study medication. They are carried out under very strict protocols designed to determine the effectiveness of the drug. Study participant’s relationship with the clinical trial doctors may be different than that of a primary care doctor. Primary care doctors have the flexibility to do whatever they think is in the patient’s best interest to promote health. Clinical trial doctors must follow the protocols designed by the pharmaceutical company (known as the “sponsor”).
Before a new medication can be made available to the general public, it needs to be evaluated to make sure that it is safe and effective in treating the disease. This is achieved by carefully monitored clinical trials. The FDA (Food and Drug Administration) has established rigorous guidelines for how pharmaceutical companies research the drug in healthy patients first, then in those with the diagnosis that the drug is trying to help treat. Only when the results show the drug to be safe and effective can it be approved to be sold on the market.
If you choose to volunteer for a clinical trial, you will be provided a full explanation of the study including required tests and procedures, visits that you have to attend, as well as potential risks and benefits of the study.
If you agree to participate in the study, you will always be able to stop participating at any time. While in the study, you will only be asked to complete the visits and procedures that were specified in the beginning.
The initial appointment is called a prescreening visit. At the prescreening visit, the patient meets with our board-certified psychiatrist to complete a psychiatric evaluation and decide if they qualify for one of our clinical trials. Medical records will need to be accessed either before or after the visit to confirm all diagnoses and medications in which they are prescribed. This prescreening only takes about 30 minutes and patients will not be compensated for this initial visit.
Yes! Prior to clinical trials performed in humans, the drugs are extensively tested in animals. Through this process, we get a good understanding of their use, effectiveness, and safety prior to testing them in humans. Of course, there is no absolute guarantee that what you find in animals will also hold true in humans. That is why we do so much safety monitoring during the clinical trial.
The clinical trials at Suburban Research Associates are all being tested in individuals who have the diagnosis in which the drug is designed to treat. Every clinical trial is approved and monitored by the IRB (Institutional Review Board), which is an independent group of people who review clinical research to ensure the rights and welfare of the patients are protected. Patient safety is a priority at Suburban Research, and we work closely with the IRB to ensure all safety measures are met. While working with our site, all patients have 24-hour emergency access to our psychiatrist as well.
Yes! In any clinical trial, you can leave at any time, no matter what the reason. If you decide to early terminate a clinical trial, it is very important to tell your research site that you are discontinuing and why. The information provided can be important for other participants and for the sponsor to get the best information from the study. There may also be safety effects to address if you stop medication without previously informing your coordinator.
It is important to know that discontinuing a clinical trial will not cause Suburban Research Associates or your physician to treat you differently, nor will it decrease your chances to get a drug or other treatment that may benefit you. There are no repercussions for early termination of a trial.
It depends on the study and the medications you are taking. It is possible that some medications cannot be taken with the study drug and each clinical trial has different inclusion and exclusion criteria, so always disclose ALL your medications to your study coordinator and physician. This applies to any over the counter medications as well.