Services: Phase III and IV Trials

Members of the general public volunteer to participate in clinical study trials for a variety of reasons. Participation in Phase III studies offer patients access to promising medications that are not available to the general public. Phase IV studies give patients the opportunity to use medications for new and novel indications. At Bioscience Research, all patients are assured of exceptional and individualized care from either Dr. Krakow or Dr. Cueva personally for the duration of the study.

Phases III and IV studies have established research protocols that are meticulously scrutinized by the Federal Drug Administration (FDA) for their safety and appropriateness. The objective, during these studies, is to assess the safety and efficacy of specific medications and treatments. Symptom change from baseline (prior to taking medication or placebo) to the end of the study tends to be the primary efficacy measure.

There is intensive monitoring of safety and any possible side effects throughout the study. Most Phase III and IV studies are randomized, double-blind, placebo-controlled studies. This means that, to ensure the accuracy of the information gathered during the study, neither the research team nor the research subject knows if the subject is on active medication or placebo. This method of research helps insure that the data collected is unbiased and accurate.

Seventy to 90 percent of medications that undergo Phase III studies complete this phase of testing successfully. Once a Phase III study is successfully completed, the pharmaceutical company can file a new drug application to the FDA requesting approval to market the drug. Clinical research provides individuals with an opportunity to get professional treatment that they might not otherwise have access to in a safe and friendly environment. It also helps further the knowledge base of medicine, which benefits all of humanity.

To inquire about upcoming clinical trials for which Bioscience Research is recruiting patients, or their availability to undertake a particular clinical trial, please telephone 917.301.0469, or send an email to info@bioscienceresearchllc.com.

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