Clinical Trials
Overview
Clinical trials allows patients access to drugs, treatments, and therapies developed in a laboratory setting to determine if they should be made mainstream and available to the general public. The knowledge supporting these clinical trials begins as applied research and is then incorporated into a hospital setting where the drug or treatment being administered can be closely observed.
The early access that clinical trials provide is essential for patients with cancers such as mesothelioma, which has no known cure. Furthermore, patients involved in clinical trials are not only attempting to help themselves, but simply by participating, are further assisting in medical research; helping patients who have yet to be diagnosed. Clinical trials help researchers and medical experts better understand the specifics of illness and disease, improving diagnostic procedures and prognosis.
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Function of Clinical Trials
Clinical trials can be held to study a variety of medicines, treatments, and procedures. Examples of what can be studied during a clinical trial includes:
- New or secondary uses for medications that are already FDA approved.
- Testing alternative medications and therapies.
- Documenting the effectiveness of palliative procedures and how they impact a patient’s quality of life.
- Assessing diagnostic procedures.
- Testing drugs and treatments yet to be FDA approved to determine proper dosing and side effects.
- New methods for administering previously approved medications, such as taking medication by injection rather than orally.
Types and Phases
There are two types of clinical trials, observational and interventional and they differ based on whether or not the trial investigator interferes with the patient’s natural progression by administering a drug or treatment.
No matter what type of clinical trial is being held it will be labeled as one of four phases. The purpose of varying phases is to answer different sets of questions regarding the drug or treatment during the entire research process. Phases are also arranged according to the number of people involved in the study:
- Phase I—between 20-80 people
- Phase II—between 100-300 people
- Phase III—1,000-3,000 people, phase III trials are also necessary if the drug or treatment is seeking FDA approval.
- Phase IV—this phase of clinical trial can only be conducted once the drug or treatment has achieved FDA approval. During this phase an even larger group of people are involved in the study to help determine the treatment’s safety, short and long-term side effects, and whether or not the treatment can be used in conjunction with other methods.
In the United States, between 2,000 and 3,000 people are diagnosed annually with mesothelioma. Therefore, the number of people involved in mesothelioma clinical trials are generally lower than those with more common diseases and illnesses.
Benefits and Risks
With any clinical trial there can be both benefits and risks. Clinical trial information should be obtained through trusted sources and held at reputable hospitals and clinics. Clinical trials allow patients to be active in their health care and give them access to new methods and treatments, as well as expert medical care. Patients should note that there can be risks such as experiencing unpleasant or serious side-effects. The drug or treatment being studied might also prove ineffective for the patient. Furthermore, the study might be conducted in a location that requires extensive travel, time away from work, or complex dosages.
Locating a Trial
Any clinical trial, despite the illness or disease being studied will have a set of guidelines referred to as a protocol. In order for the trial investigators to accurately produce reliable results they must identify the appropriate participants. Guidelines to determine participants are considered either inclusion or exclusion criteria. Inclusion is those traits (type and stage of cancer, age, gender etc) that allow the patient to be included and exclusion criteria are those factors that would automatically exclude them.
The American Cancer Society, the National Cancer Institute, and the National Institutes of Health all maintain lists of current clinical trials, as well as results for previous ones. All of these organizations recommend that patients begin their search for information on possible clinical trials by first speaking to their doctor or other health professional. Together, with doctors familiar with their type and stage of cancer, patients can determine which studies are appropriate for them. From that point patients can contact the trial’s coordinator and discuss the trial’s requirements, deciding if it is the right option for them. Patients who are interested and match the trial’s criteria will be asked to read over and sign informed consent paperwork, which lays out the details of the trial along with possible side effects and risks. Informed consent papers are not a contractual obligation and patients can leave a clinical trial at any point they wish.
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