An Introduction to Clinical Trials

Updated: Dec 13, 2019

Medical advancement is made possible by clinical research. Whether it’s to find a cure for a disease or to improve diagnostic tactics, clinical trials are how we figure out what works and what doesn’t work. The medicine available to us today exists because of doctors, patients, and clinical research teams.

What is a clinical trial?

A clinical trial examines a medical, surgical, or behavioral intervention’s remedying potential. Clinical trials are the predominant method in determining a treatment’s efficacy. This kind of research can serve as a preventative measure, for instance, helping with early detection of disease, in addition to improving one’s current condition.

Clinical trials can test various forms of medical care, including:

· New drugs for FDA approval

· New uses of drugs that have FDA approval

· Alternative medicine (herbs, vitamins, etc.)

· Different means of administering drugs

· Tests to track early signs of a disease

· Treatment for relieving symptoms

Gen1 clinical trials are meticulously designed and orchestrated. The physician is always an expert on what is being tested, and our participants are well-informed and closely monitored.

What are clinical researchers looking for?

We conduct clinical trials to find out if a treatment can help people. Determining a treatment’s effectiveness involves thorough testing and evaluation. Are the benefits outweighing the side effects? How does this treatment affect one’s everyday life? How does the treatment compare to other, existing therapies? Such questions are posed at different stages of a clinical trial we know as the four phases.

The Four Phases

Clinical trials follow four phases: Phase I, Phase II, Phase III, and Phase IV. Going from Phase I to Phase IV can take years. It is common to refer to a clinical trial by its phase, such as a “Phase III” trial.

Phase I

Phase I clinical trials revolve around the treatment’s safety. The volunteer pool starts out small, with usually 20 to 100 participants. Researchers see how humans interact with the medicine or device and test dosage levels. 70% of Phase I trials advance to the second phase.

Phase II

In Phase II clinical trials, efficacy is the focal point. More participants are brought in, and the timeline can vary from a few months to years. Phase II trials often involve a “control” group in order to compare the new treatment to standard treatment. One-third of clinical trials complete the second stage of testing.

Phase III

Phase III clinical trials can include several hundred to several thousand patients, providing researchers with an incredibly careful, in-depth comprehension of the new treatment. 70% to 90% of trials that enter this phase reach completion. Following the conclusion of Phase III, a pharmaceutical company is able to request FDA approval.

Phase IV

Phase IV trials occur after a treatment is brought to market. During this stage, the new treatment is compared to existing treatments. Research is also conducted on the long-term effects of the drug or device.

Gen1 clinical trials provide participants access to cutting-edge treatment and exceptional care. For more information, contact us today.

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