Clinical Research Trials

Clinical trials are important in studying all aspects of medicine, not just cancer. All new treatments (drugs and medical devices) must go through clinical trials before being approved by the FDA for general use.

Clinical trials are usually conducted in distinct phases. Each phase is designed to answer specific questions. There are advantages and disadvantages to taking part in each phase of clinical trial. Phase I trials generally assess the safety of the drug or treatment while Phase II trials look at the effectiveness of a treatment. Phase III trials compare the safety and effectiveness of a treatment against the current standard treatment.

Phase I trials are the first studies that use people as participants. The treatment has already been tested in a laboratory setting and on animals, but these studies cannot always predict how a human subject will react to treatment and the side effects that may occur. These studies usually involve a small number of participants and are usually reserved for patients that do not have other good options left.

Phase II trials doctors are assessing how the cancer responds to a treatment. This may include the shrinkage of a tumor or it may be an increase in the time before a cancer returns. Larger numbers of patients are used in Phase II trials than Phase I. Generally, placebos are not used in these trials.

Phase III trials usually include several hundred patients and are often conducted in more than one location at a time. Patients are chosen to receive either the new treatment or the standard treatment. Usually the trials are “double blind” meaning neither the doctor nor the patient knows which treatment the patient is receiving.

Information on clinical trials available can be found in several places. There is no one place to get information on all the government and private clinical studies and new studies are continually starting.

National Cancer Institute Clinical Trials
The National Cancer Institute (NCI) provides the Physician Data Query (PDQ), which is a comprehensive database of cancer information. It contains a database of both open and closed clinical trials.. There are step-by-step instructions on searching the database for clinical trials.

Also, the general public can call the NCI’s Cancer Information Service (1-800-4-CANCER) to request a customized search of the PDQ database.

National Institutes of Health Clinical Trials
The National Institutes of Health (NIH) maintains an even larger database of clinical trials but not all of these are cancer specific. ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial’s purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

Coalition of National Cancer Cooperative Groups Studies
The Coalition of National Cancer Cooperative Groups (CNCCG) provides a list of cancer studies being conducted at member institutions.

Sarcoma Alliance for Research Through Collaboration
Includes interactive map of doctors running sarcoma trials. -Based in Michigan
Major cancer centers often offer lists on their web sites of the clinical trials being conducted there. Private companies, such as pharmaceutical or biotechnology firms, may list the studies they are sponsoring on their Web sites. This can be helpful if you know the company developing a particular drug or treatment.

There also are several private firms, which match patients with studies they may be eligible for. These firms usually offer their services to patients free of charge and are paid a referral fee from the organization conducting the study. The American Cancer Society Clinical Trials Matching Service is a free, confidential program that helps patients, their families and health care workers find clinical trials most appropriate to a patient’s medical and personal situation.
For more information, see: http://www.cancer.org/docroot/ETO/ETO_6.asp?from=fast or call
1-800-303-5691.

Current Clinical Trials in the Upper Midwest
Rein in Sarcoma as of February 2011 has begun posting Sarcoma related Clinical trials currently being done at the University of Minnesota Masonic Cancer Center (Minneapolis), The Mayo Clinic (Rochester, MN ) and the University of Wisconsin Medical Center (Madison, WI). For current listing click here.

Clinical Trials – Websites

ClinicalTrials.Gov
ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

ClinicalTrials.gov currently contains over 60,000 trials sponsored by the National Institutes of Health, other federal agencies, and private industry. Studies listed in the database are conducted in all 50 States and in 161 countries ClinicalTrials.gov receives over 40 million page views per month 50,000 visitors daily. At the time of this publication over 600 sarcoma trials were listed.

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