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Clinical Trials/Research
CAROLINAS HEALTHCARE SYSTEM ONCOLOGY SERVICES CLINICAL TRIALS PROGRAM

Carolinas HealthCare System (CHS) Oncology Services Clinical Trials Program is a broad-based program, with various trials designed to evaluate and improve the initial treatment of cancer, as well as the treatment of recurring or advanced cancer. Research emphasis is placed on finding better treatments for the common malignancies such as breast, melanoma, lung and prostate cancer. CHS Oncology Services Clinical Trials Program offers far more trials than any other hospital in the area. In addition, CHS has been involved with trials to evaluate investigational cancer drugs, such as Gleevec, that have now been approved for use by the FDA.

What is a Clinical Trial?
Clinical Trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose or treat cancer.

A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis and treatment are safe and effective.

What are the phases of clinical trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:

  • Phase I trials: The phase I program evaluates new (investigational) cancer drugs and drug combinations in patients with advanced cancer. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
  • Phase II trials: A phase II trial evaluates the feasibility and effectiveness of new treatments for specific cancers. Phase II studies usually focus on a particular type of cancer.
  • Phase III trials: These studies test a new drug a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random. Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.
Source: National Cancer Institute (www.cancer.gov)

What are the different types of clinical trials?

  • Government Sponsored Clinical Trials
  • Pharmaceutical Sponsored Clinical Trials
  • In-House Sponsored Clinical Trials

What steps are involved with becoming a participant of clinical trials?

  • Referral
  • Eligibility
  • Consent
  • Treatment
  • Follow-up

More Information:

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