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Clinical Trials
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Imagine suffering from a debilitating disease, and being prescribed medication after medication to ease your pain. Just when you believe you have exhausted every available treatment option, your physician tells you about an experimental drug that could provide you with the relief you’ve been searching for. If you meet the necessary criteria, you may be selected to be part of a small group that “tests” the treatment before it has official FDA approval and becomes available to the public.
This physician is speaking about a clinical trial, which is a research study that volunteers take part in to help health professionals answer specific medical questions about new treatments, therapies, medications and procedures. While pharmaceutical companies fund most trials, they can also be sponsored by physicians, medical institutions and federal agencies.
Can I Participate?
All clinical trials, regardless of what is being tested, have guidelines referred to as “inclusion/exclusion criteria.” In order to participate in a clinical trial, you must meet the inclusion criteria. Some studies require young, healthy participants, while others may need patients with existing medical conditions. The criteria is very different depending on what is being tested, and is established to ensure that nothing will interfere with the data and results of the study.
The process of a trial and the amount of people involved also varies greatly depending on the type of trial. Different types include:
- Diagnostic Trials- These are used to help medical professionals find better testing methods for diagnosing patients with a specific illness.
- Treatment Trials- These test new treatments, surgery techniques, therapies and medications.
- Prevention Trials- These are conducted to find improved ways of preventing illness in otherwise healthy individuals. This can include medications, vaccinations or changes in lifestyle.
- Quality of Life Trials- These trials are for patients that have already been diagnosed with a chronic or terminal illness. They are used to explore ways to improve the patient’s quality of life.
- Screening Trials- These test the most effective way to detect specific health conditions or illnesses.
The Process
Most trials require that the patient have a health evaluation before beginning. Specific instruction pertaining to the success of the trial will then be explained, such as changing diet, avoiding certain over-the-counter medications, etc. Trials can last anywhere from a few weeks to several months, and during that time, the participant will be monitored by a research team. Any positive of negative change in health will be recorded and studied throughout the trial.
For many of the trials that test a new drug, a portion of the subject group will be administered a placebo, which is usually nothing more than a sugar pill. This group is known as the “control” group, because the effect of the medication on those that take it is compared to the patients that do not. The groups are not told beforehand whether they have the actual medication or a placebo to ensure that their results are unbiased.
The Pros and Cons
Many people find clinical trials beneficial because it is a great way to gain access to the newest medical developments and treatments. By volunteering to be a part of a trial, you are also helping others by to contributing your time to medical research.
Some patients have nearly given up hope of being cured, only to try an experimental medication through a clinical trial, and are now better than ever. An added bonus for some is that many sponsors of clinical trials will pay the participants for their time and participation.
However, clinical trials can be a heated topic for those that feel it is putting an individual’s health in further jeopardy. There are times when a patient will have no reaction to a medication or trea
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