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What is Clininical Trial
What is e-Clininical Trial
e-Clinical Trials : Steps
Proceed for e-Clinical Trial
What's Clinical Trials
A clinical trial is a strictly monitored process. Before a pharmaceutical company can initiate testing in human subjects in a hospital or clinical setting, it must conduct extensive pre-clinical or laboratory research. This research typically involves years of experiments in animal and human cells. The compounds are also extensively tested in animals. If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug in humans. This is called an Investigational New Drug application (IND). Before enrolling in a clinical trial, you will undergo the informed consent process. At this time, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty, even after signing the consent forms.
Clinical trials have four distinct phases:
Phase One
trials use a small number of human subjects to test a new treatment that has already undergone rigorous testing on animals. Participants usually have advanced disease that hasn’t responded to standard treatments. At this stage, researchers can only predict outcomes and any possible side effects on humans. During Phase One trials, investigators determine the most effective dosage and application methods. Some disease patients have seen improvement in Phase One trials.
Phase Two
trials involve a larger group of patients, in which researchers build on what they learned in Phase One. Because more subjects are involved, investigators may discover less common side effects, and will continue to evaluate the safety of the treatment.
Phase Three
trials may involve over a thousand patients, often at several medical institutions. During this phase, the study treatment is compared to and/or combined with standard modalities (treatment methods). Some participants, the "treatment group," are given the experimental treatment and others in a "control group" are given the current standard treatment, so researchers can compare outcomes in the two groups.
Phase Four
trials occur after the treatment has been put on the market to monitor effects of long-term usage, and how it affects certain population groups. If dangerous side effects are found, the drug or treatment is taken off the market.
Choosing a Clinical Trial
Before participating in a clinical trial, discuss it with your doctor or disease specialist. Make sure to get all the details of the intended benefits and possible side effects before signing any consent forms. You can leave a clinical trial at any time, and will not be penalized for doing so.
Here are some issues to consider before enrolling in a clinical trial:
Eligibility - clinical trial investigators follow strict criteria to recruit study volunteers. Recruitment forms list "inclusion criteria": things like disease type, treatment status, medical history, age range, gender, ethnicity and other factors necessary to join the trial. Forms may also list what investigators aren’t looking for, known as "exclusion criteria."
Benefits - although clinical trials offer no guarantees, scientists have a strong belief that the study drug or treatment will provide benefits equal to or better than standard care methods. If that is the case, study volunteers will be the first to receive this new modality, and will continue to receive medical checkups to monitor their progress.
Risks - the clinical trial process is not risk-free. Study investigators have anticipated many of the side effects, but not all can be known ahead of time. If a new treatment exhibits potentially dangerous side effects, the trial is immediately discontinued and participants receive follow-up care to ensure they were not harmed. Remember, most standard disease treatments do have side effects, which include nausea, hair loss and compromised immune systems.
Duration - clinical trials can last anywhere from a few weeks to several years. Some require frequent clinic or hospital visits, which can interfere with your normal routine; others only need monthly or quarterly monitoring. Some studies, particularly Phase Three, are conducted at several locations, but if you don’t live near a trial site, you may have to consider long travel times or temporary relocation to participate.
Cost - It is essential to determine what your out-of-pocket expenses will be in a clinical trial before enrolling! You may be responsible for some or all of the costs involved, including blood work, X-rays, and other procedures. Sometimes, a biotechnology or pharmaceutical company or other research grant will sponsor a clinical trial and pay some, but usually not all expenses. Note: Usually in Canada all costs are covered in a clinical trial. Some clinical trials will even pay you to be in them. Check with the trial administrator first.
You also need to call your health insurance carrier or managed care provider to see whether they cover clinical trials. Insurance companies may deny coverage if the treatment is considered experimental, but they might pay if the study treatment is similar to something the patient would receive outside a clinical trial.
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