There are several things that should be kept in mind before appearing as a volunteer for any medical survey or a clinical trial. The newly discovered medicines or therapies related to certain medical conditions and diseases are tested for their results in clinical trials.
In order to launch any treatment or medicine for any syndrome, a successful clinical trial is very important. The victims of fibromyalgia always have eager to present themself for any clinical trial in hope of getting relieved from the symptoms but this decision should be taken very precisely.
There are all chances of success and failure of the trial process. So they should be ready for any consequences and after-effects of the procedure. This volunteer aid can be highly risky in case of failure of the treatment.
The process of testing new drugs or therapies on the human body is said to be a clinical trial. After a successful trial performed on the animals and confirmation by the FDA, the trial is done on humans. This is done after successful clinical studies and observations.
Various groups and subgroups of the volunteers are made. A placebo-a sugar pill with no effects at all but resembling the drug pill is given to one group. Tests are done in order to check the effects of the trial medicine taken by the people for a specific period of time. It is kept secret for both the volunteers and the doctors which group is provided with actual drug pill and which one is having a placebo to avoid any inconsistency of the results.
Such trials can be conducted for any treatments that may or may not involve any drugs. A recent trial was done to determine the impacts of transcranial magnetic stimulation (TMS) treatment for fibromyalgia patients. The neurochemical imbalances are altered through transmitting electrical current into the central nervous system using a specially designed machine. This clinical trial process does not involve any drugs. The trial involved providing actual TMS therapy to one group while the other group received trial therapy with no effects.
The basic steps to carry out any clinical trial process are:
-Proper medical evaluation of the volunteers
-A placebo treatment to eradicate effects of any drug for all participants for two weeks
-Random development of the group without any identification of group to the participants or the medical experts
-Drug or therapy is provided for a specific period of time
-Placebo treatment for eliminating any effects of the trial procedure is given for two weeks
-Thorough observation is made at every level of the process
People fulfilling the requirements of age, gender, a lifestyle that has the medical state for which the drug or therapy is made are mainly focused to carry out the clinical process. There are special criteria for the volunteers so the researchers select the people according to the requirements and criteria for the specific process. The criteria for any trials related to fibromyalgia are developed by the American College of Rheumatology.
Some processes demand the people who have never undergone any medical treatment or therapy while some involve the patients who have not recovered from the syndrome after trying almost every available treatment or therapy.
The benefits of volunteering for a clinical trials are:
-Fair chances of introduction of new treatment/therapy
-Can have free medical exams, tests, and evaluations
-A good way to know about your personal health
-An opportunity to collect great information by working with experienced healthcare providers and medical experts
-Have a chance to help humanity by volunteering for the treatment of diseases
The disadvantages associated with it include:
-Equal chance of being placed in the placebo group
-No assurance for relief from the harmful symptoms
-Risk of any harmful effects in case of failure of the drugs or treatments
-Time-bound till the completion of the process
People should keep in mind every factor involving their ease to have a regular visit to the clinic that is far most important throughout the process. It is a lengthy process so decisions should be made carefully for volunteering yourself for the trial. Visiting the lab at right time and providing proper information about the condition is very important.
The research must be approved by the National Institutes of Health (NIH) and the trial should be approved by FDA. The studies based on ethical standards and risk to participants should be approved by Institutional Review Board (IRB) must approve
The tests are performed for the drug or treatment that has not been introduced as a proper remedy and observed extensively so the risk of any adverse effects of the process is equally present. So people eager to present themselves as a volunteer should be properly and completely guided by the consequences associated with the treatment. A proper survey should be done to determine that people deeply understand the level of their participation, as well as any risks involved.
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