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Clinical Research Program
NexGen Oncology recognizes the important role clinical trials play in the fight against cancer and have a variety of trials going on at any one time. Our mission, by offering clinical trials, is to help accelerate the introduction of new therapies to the community and facilitate rapid FDA approval of new cancer treatment products. Clinical trials/research studies are carefully controlled and designed to help find additional ways to improve health and the effectiveness of cancer treatments. In order to protect patients and ensure consistent testing procedures, clinical protocols must be adhered to. Clinical trials may involve the testing of a drug that has been approved by the FDA but not for the purpose in which it is being given in the trial. Additionally, new drugs are also tested through clinical trials to receive FDA approval. Clinical research trials occur in three phases

Phase I: The initial introduction of a new drug to humans. The number of participates are usually small (20 to 80) and the primary goal of a phase I trial is to determine side effects, dosage and if possible early evidence on effectiveness.

Phase II: These studies evaluate the effectiveness of a drug for a particular indication or disease. This phase of study is also used to determine the effectiveness and safety associated with the drug. This phase is conducted in a relatively small number of patients (a few hundred).

Phase III: These studies are expanded controlled and uncontrolled trials that are performed after the preliminary evidence suggesting effectiveness of the drug. The purpose of this phase is to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit/ risk relationship. Phase III trials include several hundred to several thousand patients and are the last phase of clinical trials before a drug can be submitted to the FDA for approval. They also compare the new treatment to the current standard treatment.

Participation in clinical trials is voluntary and patients are required to sign an informed consent form before enrolling in a trial. The consent form describes what will be involved in the trail, including the possible risk and benefits. NexGen Oncology participates in phase II and III clinical trials. Consult with your physician about clinical trials for which you may be eligible.