There are definitely some things people should know before volunteering for a clinical trial or treatment study. Clinical trials test new medications and therapies in order to gain mainstream acceptance as treatment for particular conditions and diseases.
These trials are incredible important to the improvement of treatments and medications for different diseases and conditions, including fibromyalgia.
People with fibromyalgia may be interested in participating in clinical trials to treat their symptoms and condition, but this is an important decision.
People should thoroughly understand what it means to volunteer for a clinical trial, what will be required of them and what it means for their health. There are both benefits and negatives to being a participant in a clinical trial.
Clinical trials are processes by which drugs and new therapies are tested in human subjects. Initially, new drugs are tested on animals, and then are passed by the FDA. Next, small-scale trials are done in humans- these are known as clinical studies. After clinical studies have been conducted, clinical trials begin.
Drug trials are conducted by selecting a group and dividing it into smaller subgroups. One group usually receives a placebo- a sugar pill that has absolutely no effect, but looks exactly the same as the drug pill.
After taking the drug or placebo for a period of time, tests are done to determine the effects of the medication. Neither participants, nor the participating doctor knows which person is taking the placebo or the drug. This eliminates conflict with the actual results.
Clinical trials can also be conducted for non-drug treatments. Research is being done to see whether transcranial magnetic stimulation (TMS) can improve the pain of fibromyalgia patients. TMS uses a machine that emits tiny electrical current into the brain, ultimately altering neurochemical function.
This is only one type of clinical trial that does not involve drugs. In this study, one group will receive the TMS therapy, while another group will receive a false therapy that has no effect.
There is a process for conducting clinical trials, and the process for different drugs and treatments should be similar, following a pattern like this:
-Initial evaluation of participants
-Two-week period of placebo for all participants (to eliminate other drug interactions)
-Patients are randomly divided into groups, but do not know which group they have been put in
-Patients receive the drug/therapy for a set amount of time
-Patients are given a placebo for two weeks to clear the drug/therapy from their system
-Information is collected before, throughout, and after
People with the condition being tested for are generally invited to participate in clinical trials, although there may be specific requirements considering age, gender, lifestyle and other factors.
Researchers select the group based on these and other criteria, depending on the trial they are conducting. Clinical trials have specific criteria that they use to determine who is a good fit and who is not. The criteria for fibromyalgia are met by the American College of Rheumatology.
Some studies may be looking for participants who have never tried similar therapies, and other studies may be looking for people who feel they have exhausted every available treatment option.
There are some benefits to participating in clinical trials, which include:
-Trying a new therapy
-Receiving free medical exams, tests and evaluations
-Learning more about your personal health
-Working with experienced healthcare providers and researchers
-Assisting in advancing science and treatment of diseases and conditions
Some disadvantages of participating include:
-The chance of receiving the placebo
-No guarantee of symptom relief
-Risk of adverse effects from new drugs or treatments
-Time constraints (it takes a lot of commitment and time to participate)
People should also consider their lifestyle and whether they can accommodate regular visits to the physician and the research lab etc. Participation can be high in time demand, and participants should be prepared not only to give their time, but also to be forthcoming about all information that is pertinent to the trial.
Clinical trials are as safe as possible, knowing that the test is for a new drug that has not yet been extensively studied. People need to be aware that there could be adverse affects or interactions that have not yet come out in earlier studies.
The National Institutes of Health (NIH) must approve research and the FDA must approve trial for a new drug or therapy. The Institutional Review Board (IRB) must approve studies based on ethical standards and risk to participants.
Participating in clinical trials offer both benefits and advantages, but proper research should be done to ensure that people understand the level of their participation, as well as any risks involved.