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Clinical Trials Fact Sheet

Whatis a Clinical Trial?

Clinical trials are research studies designed to evaluate whether a new treatment or procedure is safe and effective compared to the current standard of care. The knowledge gained through cancer clinical trial research has helped scientists and doctors develop new ways to slow, halt, cure and prevent cancer. However, of the 1.3 million people who will be diagnosed with cancer this year, only 3 to 5 percent will participate in cancer clinical trials.

Progress Through Cancer Clinical Trials

Virtually every cancer treatment available today is the direct result of clinical research. Thanks in large part to the knowledge gained through clinical trials, today two-thirds of cancer patients survive at least five years after diagnosis, compared with half in the 1970s.2 Advances identified through clinical trials include:

  • Cancer screening techniques, such as mammography, Pap tests and colonoscopy, which help increase early detection rates and reduce cancer incidence and mortality
  • Chemotherapy after surgery (adjuvant chemotherapy), which can increase survival for a number of cancers, including breast and lung cancer
  • Targeted therapies, which allow doctors to target the genetic and molecular defects that make a cell cancerous, while minimizing toxicity to healthy cells
  • Cancer vaccines and "chemoprevention" drugs, which can reduce the risk of ever developing cancer
  • Gene profiling, which can yield important insights into which patients will respond to specific cancer treatments
  • New insights into the long-term health of cancer survivors, who are at greater risk of heart problems, second cancers and other health issues

Benefits of Cancer Clinical Trials

Approximately 50,000 people with cancer participate in clinical trials each year in the U.S. Benefits of participation include:

  • Access to promising new treatments that may be better than the current standard of care
  • Access to high-quality expert medical care at leading cancer treatment and research facilities
  • Opportunity to participate in efforts to find more effective cancer treatment options for trial participants and others facing the disease

PatientSafety in Cancer Clinical Trials

Patient safety is the highest priority in clinical trials. Cancer clinical trials are conducted under rigorous scientific and ethical safeguards, with participants receiving either the best medical treatment available or a new treatment that may be superior to the current standard of care. In addition to regulation by federal agencies, other safeguards are in place to ensure patient safety including:

Institutional Review Board (IRB): An independent committee of doctors, statisticians and community representatives who are responsible for ensuring that a clinical trial is ethical and that the rights and well-being of study participants are protected.

Data Safety and Monitoring Board (DSMB): A group of doctors, medical ethicists, statisticians and other health professionals who are responsible for monitoring the clinical trial for safety and scientific relevance during the course of the research.

Informed Consent: A process by which researchers ensure that every person who participates in a clinical trial understands both the potential risks and benefits. Participants are provided with written information on all aspects of the clinical trial, and may elect to stop participating at any time.

More Information on Cancer Clinical Trials

People Living With Cancer (www.plwc.org)

People Living With Cancer, the patient information website of the American Society of Clinical Oncology (ASCO), provides information on more than 120 types of cancer and cancer-related syndromes, clinical trials, coping, side effects, a database to locate an oncologist, patient support organizations and information in Spanish.

ClinicalTrials.gov (www.clinicaltrials.gov)

This site provides a list of government-sponsored clinical trials.

National Cancer Institute (www.cancer.gov)

This site provides information on both open and closed cancer clinical trials that are funded by the government, pharmaceutical companies and some international organizations.

CancerTrialsHelp.org (www.cancertrialshelp.org)

This is the website of the Coalition of Cancer Cooperative Groups, a network of clinical cancer research institutions. The site features a search tool to locate clinical trials.

CenterWatch (www.centerwatch.com)

This site offers a list of institutional review board (IRB)-approved clinical trials for cancer and other diseases.

References

1. Coalition of Cancer Cooperative Groups, About Clinical Trials: ABCs of Clinical Trials.

2. National Cancer Institute (NCI), The Nation's Progress in Cancer Research: An Annual Report for 2003.

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