What is a clinical trial?
Clinical trials are research studies that help doctors develop new therapies. These studies try to answer scientific questions while finding ways to prevent, diagnose, and treat cancer. Today's clinical trials lead to tomorrow's standard care.

Why are clinical trials especially important to children?
Most children with cancer enroll in clinical trials. Most clinical trials for childhood cancer are sponsored by the National Cancer Institute's (NCI) Children's Oncology Group (COG), formed by a merger of the Pediatric Oncology Group, Children's Cancer Group, Wilms Tumor Study Group, and Intergroup Rhabdomyosarcoma Study Group.

What are the phases/types of clinical trials?

Phase I trials evaluate how a new drug or treatment regimen should be administered, how often, and in what dosage. New drugs must show clear evidence of great promise in the lab before being tested on people.

Phase II trials assess efficacy of treatment for particular types of cancer and provide more information about safety.

Phase III trials compare promising new treatments against the best standard treatment to date. If the new treatment proves effective, it may become the new standard.

How is the research plan developed?
The principal investigator (research doctor) writes a detailed action plan, called a protocol, that describes what will be done in the clinical trial and why. Each protocol goes through a rigorous review in the Children's Oncology Group, at the NCI, and at the hospital where patients are enrolled. Protocols specify requirements of the patients who are eligible to enroll in the clinical trial, as well as characteristics of their disease.

What is informed consent?
Informed consent is the process by which potential study participants and their families learn key facts about a clinical trial before deciding whether or not to participate. The potential study participants and their families talk with the research doctor or nurse about the trial and must review a written consent form. The consent form includes details about the study approach, the intervention given in the trial, the possible risks and benefits, and tests associated with the trial.

What are the benefits vs the risks of participating in a clinical trial?

Potential benefits include:

• Health care provided by leading physicians in cancer research
• Access to new drugs and interventions before they are widely available
• Close monitoring of health care and any side effects
• Being among the first to receive a therapy if the intervention is effective
• An opportunity to make a valuable contribution to cancer research.

Potential risks include:

• New drugs and procedures may have side effects or risks unknown to the doctors
• Side effects and results may be worse from interventions than from standard treatment
• Health insurers and managed care providers may not always cover all the care costs in a clinical trial.