Clinical trials (Salem Health: Cancer)
Cancers addressed: Clinical trials are offered for patients with many kinds of cancers to evaluate new treatment options or altered treatment options or new indications for existing cancer therapies.
Training and certification: The required qualification and obligations of a clinical investigator to conduct a clinical trial are outlined in the regulations of the Food and Drug Administration and the Good Clinical Practice (GCP) guidelines.
According to these regulations and guidelines, the principal clinical investigator (PI) of a clinical trial must, for example, submit a detailed curriculum vitae showing that the person is qualified by training and experience to investigate a new drug or method. The person should have at least two years’ experience in conducting clinical trials. The PI is trained in detail about the new drug or method before the beginning of a clinical trial. This training is provided by the clinical trial sponsor, which is normally a pharmaceutical company developing the drug. The training includes reviewing the clinical investigator’s brochure, a document prepared by the trial sponsor and containing all known relevant information on the investigational product, including preclinical, pharmacokinetic, and pharmacodynamic data in animals and in humans as well as data from earlier clinical trials. The training also includes how to properly report potential side effects in the...
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For Further Information (Salem Health: Cancer)
Blichert-Toft, M., H. Mouridsen, and K. W. Andersen. “Clinical Trials.” International Seminars in Surgical Oncology 12 (1996): 32-38.
Friedman, L. M., C. D. Furberg, and D. L. DeMets. Fundamentals of Clinical Trials. 3d ed. New York: Springer, 1998.
Jenkins, V., and L. Fallowfield. “Reasons for Accepting or Declining to Participate in Randomized Clinical Trials for Cancer Therapy.” British Journal of Cancer 82 (2000): 1783-1788.
Olver I., et al. “The Adequacy of Consent Forms for Informing Patients Entering Oncological Clinical Trials.” Annals of Oncology 6 (1995): 867-870.
Thornton, H. “Clinical Trials: A Brave New Partnership.” Journal of Medical Ethics 20 (1994): 3-4.
Verheggen, F., R. Jonkers, and G. Kok. “Patients’ Perceptions on Informed Consent and the Quality of Information Disclosure in Clinical Trials.” Patient Education and Counseling 29 (1996): 137-153.
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Organizations and Professional Societies (Salem Health: Cancer)
Association of Clinical Research Professionals. http://www.acrpnet.org, 500 Montgomery Street, Suite 800, Alexandria, VA 22314.
Society of Clinical Research Associates. http://www.socra.org, 530 West Butler Avenue, Suite 109, Chalfont, PA 18914.
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Other Resources (Salem Health: Cancer)
Abramson Cancer Center of the University of Pennsylvania. Oncolink/Emerging Med Cancer Clinical Trials Matching Service. http://www.oncolink.com/treatment/matching.cfm
CenterWatch. Clinical Trial Listings Service. http://www.centerwatch.com
International Conference on Harmonisation of Technical Requirement for Registration of Pharmaceuticals for Human Use. http://www.ich.org/cache/compo/276-254-1.html
National Cancer Institute. Finding Clinical Trials. http://www.cancer.gov/clinical_trials
U.S. Food and Drug Administration. http://www.fda.gov
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Indications and Procedures (Magill’s Medical Guide, Sixth Edition)
Clinical trials offer the most reliable process for bringing new drugs and medical treatments into public use. The process has features that can protect human participants, avoid biases, ensure that patient improvements are due to the experimental treatment and not to other factors, and allow accurate comparison of the experimental treatment with others on the market. Clinical trials are usually initiated and managed by academic institutions (often with grant funding), pharmaceutical companies, or government research agencies, such as the National Cancer Institute.
In 1998, it was estimated that the cost of developing a new drug was, on average, $500 million, and the process could take twelve to fifteen years—from discovery and laboratory testing, through clinical trials, to Food and Drug Administration (FDA) approval, and finally getting the drug to market. By the late 1990’s, a new drug might go through sixty-eight clinical trials. The average number of patients enrolled in a trial was 3,800.
Clinical trials fit into one of four types. Phase I trials, which usually involve only twenty to one hundred seriously ill patients, try to determine how to administer a new drug, the maximally tolerated dose (MTD), how the human body processes the drug, and any significant side effects. Phase II trials, which are usually randomized, treat up to several hundred patients who all have measurable rates of disease....
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Uses and Complications (Magill’s Medical Guide, Sixth Edition)
The 1979 Belmont Report detailed three ethical principles to guide clinical trials. They include respect for persons (abiding by their opinions and choices as autonomous agents), beneficence (doing no harm and maximizing the possible benefits while minimizing possible harm), and justice (distributing the benefits and burdens of research fairly).
Two standard features of clinical trials help ensure that ethical principles are being followed. First, all clinical trials in the United States must be approved and monitored by an Institutional Review Board (IRB), which includes both scientists and laypersons. Multicenter trials must also have a data safety and monitoring board composed of independent experts. This group monitors data from the trial regarding the treatment’s effectiveness and any adverse reactions. Second, the detailed informed consent document that patients must carefully consider and sign gives a number of categories of information. Most important, anticipated physical risks and discomforts are explained, as are financial risks.
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Perspective and Prospects (Magill’s Medical Guide, Sixth Edition)
In October, 1948, The British Medical Journal published an article reporting on what was probably the first study using all the methodological features of the randomized clinical trial. Since then, the randomized clinical trial has come to be regarded as perhaps the most important medical achievement of the twentieth century. It transformed biomedical research and allowed physicians to make treatment choices based on scientific evidence rather than personal opinion and experience.
The National Cancer Institute (NCI) and other sources reported a small participation rate in clinical trials—ranging in the late 1990’s from 3 to 20 percent of patients. One of many causes was that insurance companies and managed care providers frequently refused payment for experimental treatments. Their concerns were that they might be liable for adverse reactions or additional care after the trial ends and that clinical trials are more costly than conventional treatments. Because so many insurers would not cover the costs of clinical trials, researchers had trouble finding patients willing to participate, thus slowing the development of more effective drugs and treatments. Insurers gradually realized that more widespread coverage of the costs of trials might speed the development of better drugs, which could ultimately save them money. In 1998, states began to pass laws requiring insurers to cover the routine medical costs...
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For Further Information: (Magill’s Medical Guide, Sixth Edition)
CenterWatch Clinical Trials Listing Service. http://www.centerwatch.com.
Finn, Robert. Cancer Clinical Trials: Experimental Treatments and How They Can Help You. Sebastopol, Calif.: O’Reilly, 1999.
Green, Stephanie, Jacqueline Benedetti, and John Crowley. Clinical Trials in Oncology. 2d ed. Boca Raton, Fla.: Chapman & Hall, 2003.
Harrington, David P. “The Randomized Clinical Trial.” Journal of the American Statistical Association 95, no. 449 (March, 2000): 312-315.
Malay, Marilyn. Making the Decision: A Cancer Patient’s Guide to Clinical Trials. Sudbury, Mass.: Jones and Bartlett, 2002.
Quinn, Susan. Human Trials: Scientists, Investors, and Patients in the Quest for a Cure. Cambridge, Mass.: Perseus, 2002.
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Clinical Trials (Encyclopedia of Cancer)
A clinical trial is a research study designed to answer specific medical questions regarding cancer care.
The clinical trial is a scientific study that follows a written guideline (protocol) or recipe for treatment. It is the only scientific mechanism designed to test the effectiveness of new and promising therapies. The clinical trial provides intensive testing of new or updated treatment regimens. Almost all standard treatments in the field of oncology (cancer) originated from clinical trials. These trials are conducted by medical, surgical and radiation oncologists (cancer specialists).
Cancer clinical trials are the key to preventing, diagnosing and treating all types of cancer. It is estimated that 60% of all cancer patients in the United States are being cured. Yet, fewer than 3% of adult cancer patients participate in clinical trials. In contrast, about 71% of children enter clinical trials. This has led to major advancements in treatment and high cure rates for many childhood cancers such as Wilms' tumor (malignant neoplasm of the kidney), osteosarcoma (tumor of the bone), and childhood leukemia (cancer of the blood).
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Clinical Trials (Encyclopedia of Neurological Disorders)
A clinical trial is a carefully designed research study that is carried out with human volunteers. The trial is designed to answer specific questions concerning the effectiveness of a drug, treatment, or diagnostic method, or to improve patients' quality of life.
Qualification for a clinical trial involves the selection of various desirable criteria (inclusion criteria), as well as criteria by which volunteers are rejected (exclusion criteria). Typical criteria include age, gender, the type and severity of the disease, prior treatment, and other medical conditions.
Depending on the clinical trial, the volunteers that are recruited could be healthy or ill with the disease under study. There are a number of different types of clinical trials that utilize differing types of study plans (protocols). A treatment trial evaluates a new treatment, new drug combinations, new surgical strategies, or innovative radiation therapy. A prevention trial seeks to find better ways to prevent disease from occurring or prevent disease from returning. Medicines, vaccines, vitamins, and lifestyle changes can all be candidates for a prevention trial. A diagnostic trial is designed to find better means of diagnosis for a particular disease or medical condition. A screening trial is designed to determine the...
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