A History of Discovery, Research, Dedication
Finding the Best Care
When patients hear the synonymous terms “clinical research,” “clinical trial” or “research study,” many different thoughts come to mind. Some people associate “research” with data gathering, others with advanced disease states for which there is no hope other than a “research trial,” others associate these trials as an opportunity to gain access to the latest therapies before they are available to the general public and there are some that view these endeavors as being a “guinea pig.” All of these are true and false to some degree.
People choose to participate in a clinical trial for a variety of reasons:
- Financial – Most trials or studies provide the visits and the medications at no cost to the patient. Often, competing and already FDA-approved treatments are quite expensive. Sometimes, a small amount of monetary compensation is given to the participant to offset their time and travel.
- Lack of other options – Sometimes, currently available treatments have failed or have risks that are too great and non-FDA-approved treatments are the best or only option.
- Access – Participants gain access to drugs or devices before they are available to the general public.
- Altruism/Advancement of knowledge – Patients often participate in studies in order to help those that follow them, realizing that all knowledge is built on small, prior steps. They reason that a new drug may help them, but even if it does not, this is important knowledge so that attention may be directed elsewhere in the future.
- Close monitoring – Patients in clinical studies generally receive more extensive testing and visits than general patients. They often find close relationships with members of the Research Team.
Clinical Research Phases
“Clinical research” is the broad term that includes the process by which any new medication or medical device becomes FDA approved. Without this approval, a company cannot market a product for human use in the US. The path to FDA approval begins with “lab” research. This is where the basic science of a drug is worked out. Today, this often involves computer modeling and very high-tech methods.
Once a drug shows promise in the lab, it is tested in animals to make sure that it is both safe and has potential to work. If this test is passed, the drug moves into human testing. This part of the approval process is divided into three phases:
The drug is given to a small number of people to evaluate its safety, determine a safe dosage range, and identify side effects.
The drug is given to a larger number of people to see if it is effective and to further evaluate its safety. Safety remains the primary question and a drug must pass this “safety test” without question to move to the next phase.
The drug is given to a very large number of people to further study its effectiveness and side effects. Effectiveness is the main subject with safety still being important.
If you would like more information on our current clinical research studies, please contact Christina Smith at firstname.lastname@example.org.
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