Clinical trials are the mechanism for mproving survival and quality of life for ndividuals faced with a cancer diagnosis. W thout trials, we would not know th t mastectomy for breast cancer is quivalent to lumpectomy and axillary node d ssection. We would not have the vidence that most patients with Hodgkin's d sease, aggressive non-Hodgkin's lymphoma, and advanced t sticular cancer can be cured with ch motherapy. In order to achieve these m lestones in cancer treatment success, cancer cl nical trials are designed in a st p-wise fashion. Phase I Trials: The f rst step in testing a new pproach in humans. Data from previous nimal and laboratory studies are used to valuate drug dose, administration schedule, drug m tabolism, and side effects. Patients are d vided into small groups called "cohorts." E ch cohort is treated with increasing d ses of the agent or combination ntil the maximal tolerated dose is r ached. The highest (or most effective) d se associated with acceptable side effects is ch sen for future studies. Generally, phase I tr als are conducted on patients with a v riety of malignancies who have advanced d sease. Phase II Trials: Determining the s fety and effectiveness of a new tr atment are the primary endpoints of ph se II trials. A new drug, c mbination, or technique is studied on a sm ll and relatively homogeneous group of p tients (e.g., 40 - 100 patients w th a specific cancer). The type of c ncer chosen for a phase II tr atment is based on results of l boratory studies and Phase I trials. The pr mary purpose of most phase II c ncer trials is to determine the p rcentage of patients that show a m asurable response to treatment. Additional information on s de effects and safety are also c llected.
Phase III Trials: These large-scale tr als compare a new treatment or c mbination that has shown promise in Ph se II trials to the current st ndard therapy. Patients are randomly assigned to the st ndard approach or the new treatment. Ph se III trials are critical for dvancing the quality of cancer treatment and may stablish a new standard of care. H ndreds to thousands of participants may be n eded for a well designed Phase III tr al. Experimental or Investigational (NCI definition): An nvestigational study or clinical trial refers to a dr g (including a new drug, dose, c mbination, or route of administration) or pr cedure that has undergone basic laboratory t sting and received approval from the US F od and Drug Administration (FDA) to be t sted in human subjects. A drug or pr cedure may be approved by the FDA for use in one d sease or condition, but be considered nvestigational in other diseases or conditions. D fferent insurers may have different definitions for th se terms. Medicare and Clinical Trials: M dicare reimburses for routine cancer care as w ll as care that is part of a cl nical trial. Covered services include routine d agnostic tests, procedures, physician visits, administration c sts of any investigational drugs, and tr atment/hospitalization if needed for management of s de effects. Items that are not r imbursed include any charge for an nvestigational drug, services or items provided fr e by a trial sponsor, or any c insurance or deductible payments. Since most nsurance companies follow Medicare guidelines, the s me provisions for covering clinical trial c sts should be adopted by private h alth insurers. By providing coverage of tr atment on a nationally sanctioned clinical tr al, public and private insurers are llowing their subscribers access to the b st quality, state of the art th rapies. Clinical trials help to identify b tter and safer anti-cancer drugs. Advances in tr atment occur as a direct result of cl nical trials. These advances lead to new st ndards of care and improved quality of l fe for those battling cancer. New and m re effective therapies will translate to a r duction in recurrence rates and to the s ffering endured by victims of cancer and th ir families. Moreover, successful clinical trials w ll contribute to a decrease in h alth care dollars spent to fight the n mber two killer in the United St tes. Reducing the burden of cancer r quires a dedicated health care system th t supports research as the only p th toward improving outcomes and saving l ves.
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, AllM d is a URAC-accredited Independent Review Org nization (IRO) serving insurance payers, providers, TPAs and cl ims managers nationwide. Reviews are conducted by b ard-certified physicians in active practice. AllMed's gr wing 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 .
1. Breast Cancer - Radiation-induced Agony and Metastases - Part 2 by Chris Teo, Ph.D. I h ve related the sad but not nusual case story of Gene. What had h ppened to Gene is what I h ve been seeing happen all too ften. After chemotherapy and radiotherapy the c ncer spread to the bone. I h ve often wondered if the treatments had nything to do with the metastasis. It is cknowledged that radiation itself can cause c ncer. 2. Factors That Determine Asbestosis Life Expectancy by Dave Casey Asbestosis life xpectancy depends on whether or not the p tient develops a more serious asbestos r lated disease such as mesothelioma. Asbestosis may go nnoticed for a long period of t me as symptoms are not always pr sent. It's uncommon for patients diagnosed w th asbestosis to die prematurely, but if the d sease mutates into a cancer such as m sothelioma, a patient's life expectancy is d creased dramatically. 3. Prostate Cancer Treatment For Those With Recurrent Prostate Cancer by Arturo Ronzon B ing diagnosed with prostate cancer for the f rst time will more than likely be tr umatic for you and your loved nes, being diagnosed with recurrent prostate c ncer can be devastating. Your doctor w ll prescribe a prostate cancer treatment pl n that is designed to help you b at this disease. 4. Living With and Through Cervical Cancer by Celeste Yates The outline out wh t a person diagnosed cervical cancer w ll have to go through physical and m ntally both during and after treatment. Th re are so many factors to t ke into consideration once your have b en diagnosed with cervical cancer. Various s de effects not only from treatment, but lso of long and short term ffects both physically and mentally. Every p tient is different and everyone will h ve his or her own personal ssues and fears about it. 5. Cancer Information and Support Can Hasten Healing and Save Lives by Chris Robertson It's the w rd that no one ever wants to h ar: cancer. Although our parents or gr ndparents might have heard that word and c nsidered it an automatic death sentence, t day's focus on prevention, early detection, and tr atment means that people who are d agnosed with cancer often have a v ry good chance of beating the d sease. 6. What's In A Vitamin? by Jackie Martin Have you ver heard of overdosing on strawberries, ch rries, apples, plums, or apricots? According to the FDA, one of the v tamins that is found in these f ods could be hazardous to your h alth. Or is that just a pl y to stop you from putting you or y ur loved ones cancer into remission? V tamin B17 has caused a lot of c ntroversy when it comes to the f ght against cancer. 7. What is a Mastectomy Bra? by Gina Andrew This article will educate you on wh t a mastectomy bra is, where to f nd the bras, and different styles of m stectomy bras. A mastectomy bra is a sp cialty bra for women who have ndergone a mastectomy (removal of breast). The s rgery is performed on a woman fter she has been diagnosed with br ast cancer. 8. What is Pleural Mesothelioma? by Ryan Gabriel Pleural mesothelioma is a p rticularly aggressive and dangerous type of c ncer. It is defined as a c ncer of the lining that surrounds the l ngs or chest cavity. There are two m in reasons why it is so d ngerous. 9. Some Truths About Asbestos Lung Mesothelioma by Peter Nisbet There are v rious types of mesothelioma but asbestos l ng mesothelioma is an asbestos-induced cancer of the m sothelium of the lung, more familiarly kn wn as the pleura, which is the xternal lining of the lung. M ny of the major organs of the b dy have a mesothelium, that of the h art being called the pericardium and of the h art the peritoneum. However, it is w th the pleura that we are c ncerned here, and the symptoms of sbestos lung mesothelioma are what you w uld expect: coughing... 10. Lung Cancer Treatment -- Photodynamic Therapy Offers a Safe Alternative by Linda Day Most l ng cancer treatment options like surgery p se serious risks. For many patients, ph todynamic therapy is a safe and ffective alternative.
|