What are Clinical Trials

Research studies are conducted in order to obtain the most current information for medications and the disease process. The development of new drugs may offer advantages over current treatment options. Research helps to bring new medications, vaccines, surgical procedures and devices, and other treatment options to the fingertips of the medical community. Not all research involves newly developed medications. Clinical trials may also be done on existing medication or products to facilitate their use in other indications.

The pharmaceutical company provides financial support to clinical research sites to conduct clinical trials. There is never a charge to the patient or the physician for services provided while participating in a clinical trial; nothing is billed to the patient’s insurance company. Volunteers are compensated for their participation.

Types of Studies
A pharmaceutical company conducts preclinical and laboratory trials prior to human testing. This provides them with data to submit to the Food and Drug Administration (FDA) for approval to conduct trials in humans. Once approved for human testing, a drug or device will undergo four phase of studies. The first three phases are conducted in order to obtain approval from the FDA to market the device or drug. The fourth phase is done after marketing approval. In all phases of development the primary concern is the safety of the drug or device as well as how effective it is in the treatment of the indication.

Phase I Studies
These studies are primarily concerned with learning more about the safety of a drug and the side effects that occur as dosage levels are increased. This phase uses only healthy volunteers. Only about 70% of experimental drugs pass this phase.

Phase II Studies
Once a drug has been proven safe, it must be tested for effectiveness. These trials usually involve volunteers who have the diagnosis that requires the treatment being used in the trial. Some volunteers will be in a group that is given the experimental drug and others will be in another group that is given a placebo (no active drug). These trials are randomized, which means the volunteers will be assigned to the treatment group randomly (like the flip of a coin). Usually the physician, patient and research staff is unaware of which patients are assigned to each group. This phase of trials provides the pharmaceutical company and the FDA with comparison data about the safety and efficacy of the drug. Only a third of experimental drugs pass both Phases I and II trials.

Phase III Studies
These trials are conducted in large groups of volunteers. They provide the pharmaceutical company and the FDA with a more thorough understanding of the drugs effectiveness, benefits and side effects. Ninety percent of drugs will successfully complete this phase. Once a drug has completed this phase the pharmaceutical company can request FDA approval to market the drug or device.

Phase IV Studies
These trials are done after a drug as been approved. They provide even more information about the drug and sometimes comparisons to other medications for the same indication.

Benefits of Participation
Volunteers usually receive exams, laboratory tests and other study related procedures at no cost. Compensation for time and travel are usually provided. Your participation in a clinical study will increase knowledge in medications, general health and the disease process. The data obtained from clinical studies will be used to further the development of newer and safer products for generations of patients to come.

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