Compassionate Use: A way to provide experimental, not-yet-approved treatment to patients who are critically ill and are not responsive to other treatments. Physicians may need to get case-by-case approval from the FDA for "compassionate use" of a drug or therapy.
Inclusion/Exclusion Criteria: These determine whether an individual may take part in a clinical trial. Criteria are based on age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Investigational New Drug Application (IND): After preclinical testing, a company files an IND with the FDA to begin to test the drug in humans. The IND becomes effective if the FDA does not disapprove it within 30 days. The IND describes prior experiments, the new study protocol, the composition and manufacture of the investigational drug, and any toxic effects found in the animal studies.
Orphan Drugs: Medications for diseases and conditions that occur rarely. Pharmaceutical companies have little financial incentive to develop drugs for these diseases. Orphan drug status, conferred by the FDA, gives a manufacturer specific financial incentives to develop such medications.
Phase 3: A drug that shows positive results in small groups of patients may be studied in a larger phase 3 trial to confirm its efficacy and note adverse events that occur with long-term use. Hundreds or thousands of patients may be involved.
Office-based physicians can earn significant revenue by conducting clinical trials. Here's a look at the pros and cons to decide whether trials are right for a practice.
Medscape Business of Medicine, June 2, 2010
Carmen Arismendy, MD, CCRC
CEO and President, Arysmed LLC, Ridgewood, New Jersey www.arysmed.com Dr. Arismendy is a Certified Clinical Research Coordinator. She has previously worked as a research coordinator at Mt. Sinai Hospital in New York City and in clinical investigation with New York University Hospital.
Kenneth A. Getz, MBA Senior Research Fellow, Tufts Center for the Study of Drug Development (CSDD), Tufts University, Boston, Massachusetts
Founder and Chairman, Center for Information and Study on Clinical Research Participation (CISCRP) and CenterWatch, Boston, Massachusetts