Welcome to the Somerset Hematology-Oncology Associates Research Program

Our mission is to support the prevention and treatment of cancer by providing the latest cutting-edge treatments -- available only through clinical studies.     

Clinical research studies aid in the development of new drugs by helping to take the discoveries made in biotech laboratories and translate them into practical applications that may potentially improve health and save lives.

Because of our affiliation with national biotechnology and pharmaceutical companies, Somerset Hematology-Oncology’s Research Program is afforded the opportunity to offer numerous, wide-ranging industry sponsored clinical research studies.

Our research program was established in 1998 and we are committed to its continuation and growth and our dedication to expanding our physicians' roles as clinical investigators.

Through our continued support of clinical research, Somerset Hematology-Oncology is a valuable resource in providing advanced treatment options for our patients while assisting in the advancement of cancer research and treatment.

To learn more about the clinical studies available in our office, contact our Research Coordinator, Demmie Aguilar, C.C.R.P., at (908) 927-8705 or via e-mail at 
                                            SomersetResearchNJ@gmail.com
                                                                
                                                                
                                                                  Demmie Aguilar, C.C.R.P.

How are Clinical Trials conducted?

The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or "phase four" studies.

A Phase I Study:

Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of volunteers  (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing.

A Phase II Study:

Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies.

A Phase III Study:

In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials.

Phase III studies typically last several years. Seventy to 90 percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug. 
Phase IV studies look at drugs that have already received FDA approval. Therefore they are already available for doctors to give to patients. But these studies are still needed to answer important questions.

A Phase IV Study:

When considering taking part in a phase IV trial, patients should know that the drug has already been approved for use.

They do not need to enroll in the study to get the medicine. At the same time, the care they would receive in these types of studies is often very similar to what they could expect if they were to get the treatment outside of a clinical trial. They should be reassured that in participating they would be receiving a form of treatment that has already been studied extensively and that they would be doing a service to future patients.
    
                                   SomersetResearchNJ@gmail.com