Access to Investigational DrugsThe process of new drug development has many parts. In the United States, until a drug has been approved by the FDA, it can generally be obtained only through several mechanisms: enrollment in a clinical trial studying the drug, an expanded access program, or special exemption/compassionate use programs. See Access to Investigational Drugs: Questions and Answers for more information. Group C DrugsIn the 1970s, researchers from the NCI became concerned about the lag between the date when an investigational drug was found to have anti-tumor activity and the time that drug became available on the market. Working with the FDA, the NCI established the Group C classification system to allow access to certain drugs. Group C drugs are provided to properly trained physicians who have registered using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Each Group C drug protocol specifies patient eligibility, drug use, and how information about the patient's use of the drug should be reported. Group C designation (now called Group C/Treatment INDs) speeds new drugs to patients who need them most. The process also allows the NCI to gather important information on the safety and activity of the drugs as they are used in the "real world" prior to their final FDA approval. Group C drugs are always provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Treatment INDsIn 1987, the FDA began authorizing the use of new drugs still in the development process to treat certain seriously ill patients. In these cases, the process is referred to as a treatment investigational new drug application (Treatment IND). Clinical trials of the new drug must already be underway and have demonstrated positive results that can be reproduced. The FDA sets guidelines about what constitutes serious and life-threatening illnesses, how much must already be known about a drug's side effects and benefits, and where doctors can obtain the drug for treatment. For many seriously ill patients, the risks associated with taking a not-yet-completely proven drug are outweighed by the possible benefits. If you have mesothelioma, we might be able to help you. Fill out this form. This website is sponsored by Jonathan David* of The
David Law Firm. The David Law Firm is located in The Woodlands, Texas
(Greater Houston Area) and can be reached toll free at 1-800-998-9729
for more information on mesothelioma. Jonathan David is not a medical
doctor. The information on these pages is for the education of mesothelioma
patients and their families regarding potential medical and legal
options. Patients are advised to consult with a medical doctor.
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use of chemotherapy in patients with advanced malignant pleural mesothelioma:
a clinical practice guideline.
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