Epstein JB, Sciubba J, Silverman S Jr, Sroussi HY Utility of toluidine blue in oral premalignant lesions and squamous cell carcinoma: continuing research and implications for clinical practice. Head Neck. 2007 Oct;29(10):948-58. Review.
Feuer EJ, Kessler LG Test statistic and sample size for a two-sample McNemar test. Biometrics. 1989 Jun;45(2):629-36. Erratum in: Biometrics 1989 Sep;45(3):1039.
Genden EM, Desai S, Sung CK Transoral robotic surgery for the management of head and neck cancer: a preliminary experience. Head Neck. 2009 Mar;31(3):283-9. doi: 10.1002/hed.20972.
Gillenwater A, Jacob R, Richards-Kortum R Fluorescence spectroscopy: a technique with potential to improve the early detection of aerodigestive tract neoplasia. Head Neck. 1998 Sep;20(6):556-62. Review.
Kerawala CJ, Beale V, Reed M, Martin IC The role of vital tissue staining in the marginal control of oral squamous cell carcinoma. Int J Oral Maxillofac Surg. 2000 Feb;29(1):32-5.
Martin IC, Kerawala CJ, Reed M The application of toluidine blue as a diagnostic adjunct in the detection of epithelial dysplasia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Apr;85(4):444-6.
McNeil BJ, Weichselbaum R, Pauker SG Speech and survival: tradeoffs between quality and quantity of life in laryngeal cancer. N Engl J Med. 1981 Oct 22;305(17):982-7.
Rosenberg D, Cretin S Use of meta-analysis to evaluate tolonium chloride in oral cancer screening. Oral Surg Oral Med Oral Pathol. 1989 May;67(5):621-7.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
