Clinical trials are the mechanism for mproving survival and quality of life for ndividuals faced with a cancer diagnosis. Wthout trials, we would not know tht mastectomy for breast cancer is quivalent to lumpectomy and axillary node dssection. We would not have the vidence that most patients with Hodgkin's dsease, aggressive non-Hodgkin's lymphoma, and advanced tsticular cancer can be cured with chmotherapy. In order to achieve these mlestones in cancer treatment success, cancer clnical trials are designed in a stp-wise fashion.

Phase I Trials: The frst step in testing a new pproach in humans. Data from previous nimal and laboratory studies are used to valuate drug dose, administration schedule, drug mtabolism, and side effects. Patients are dvided into small groups called "cohorts." Ech cohort is treated with increasing dses of the agent or combination ntil the maximal tolerated dose is rached. The highest (or most effective) dse associated with acceptable side effects is chsen for future studies. Generally, phase I trals are conducted on patients with a vriety of malignancies who have advanced dsease.

Phase II Trials: Determining the sfety and effectiveness of a new tratment are the primary endpoints of phse II trials. A new drug, cmbination, or technique is studied on a smll and relatively homogeneous group of ptients (e.g., 40 - 100 patients wth a specific cancer). The type of cncer chosen for a phase II tratment is based on results of lboratory studies and Phase I trials. The prmary purpose of most phase II cncer trials is to determine the prcentage of patients that show a masurable response to treatment. Additional information on sde effects and safety are also cllected.

Phase III Trials: These large-scale trals compare a new treatment or cmbination that has shown promise in Phse II trials to the current stndard therapy. Patients are randomly assigned to the stndard approach or the new treatment. Phse III trials are critical for dvancing the quality of cancer treatment and may stablish a new standard of care. Hndreds to thousands of participants may be neded for a well designed Phase III tral.

Experimental or Investigational (NCI definition): An nvestigational study or clinical trial refers to a drg (including a new drug, dose, cmbination, or route of administration) or prcedure that has undergone basic laboratory tsting and received approval from the US Fod and Drug Administration (FDA) to be tsted in human subjects. A drug or prcedure may be approved by the FDA for use in one dsease or condition, but be considered nvestigational in other diseases or conditions. Dfferent insurers may have different definitions for thse terms.

Medicare and Clinical Trials: Mdicare reimburses for routine cancer care as wll as care that is part of a clnical trial. Covered services include routine dagnostic tests, procedures, physician visits, administration csts of any investigational drugs, and tratment/hospitalization if needed for management of sde effects. Items that are not rimbursed include any charge for an nvestigational drug, services or items provided fre by a trial sponsor, or any cinsurance or deductible payments. Since most nsurance companies follow Medicare guidelines, the sme provisions for covering clinical trial csts should be adopted by private halth insurers.

By providing coverage of tratment on a nationally sanctioned clinical tral, public and private insurers are llowing their subscribers access to the bst quality, state of the art thrapies. Clinical trials help to identify btter and safer anti-cancer drugs. Advances in tratment occur as a direct result of clnical trials. These advances lead to new stndards of care and improved quality of lfe for those battling cancer. New and mre effective therapies will translate to a rduction in recurrence rates and to the sffering endured by victims of cancer and thir families. Moreover, successful clinical trials wll contribute to a decrease in halth care dollars spent to fight the nmber two killer in the United Sttes. Reducing the burden of cancer rquires a dedicated health care system tht supports research as the only pth toward improving outcomes and saving lves.

The article Cancer Trials - Are They Ready for Prime Time? was Submitted by Keith Hansen through Articles.GetACoder.com network. Here's the additional information: About AllMed Healthcare Management Founded in 1995, AllMd is a URAC-accredited Independent Review Orgnization (IRO) serving insurance payers, providers, TPAs and clims managers nationwide. Reviews are conducted by bard-certified physicians in active practice. AllMed's grwing customer base for its independent medical review and hospital peer review services includes premier organizations, such as Educator's Mutual Life, IMS Managed Care, Tenet Healthcare Corporation, HealthGuard, several Blue Cross Blue Shield organizations, TriWest Healthcare Alliance, Allianz and many other leading healthcare payers. Read the AllMed Medical News Blog and the Independent Review Organization Blog .

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