Hsieh CC The effect of non-differential outcome misclassification on estimates of the attributable and prevented fraction. Stat Med. 1991 Mar;10(3):361-73.
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Paffenbarger RS Jr, Lee IM, Leung R Physical activity and personal characteristics associated with depression and suicide in American college men. Acta Psychiatr Scand Suppl. 1994;377:16-22.
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Sahi T, Paffenbarger RS Jr, Hsieh CC, Lee IM Body mass index, cigarette smoking, and other characteristics as predictors of self-reported, physician-diagnosed gallbladder disease in male college alumni. Am J Epidemiol. 1998 Apr 1;147(7):644-51.
Sasco AJ, Paffenbarger RS Jr Measles infection and Parkinson's disease. Am J Epidemiol. 1985 Dec;122(6):1017-31.
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Sesso HD, Paffenbarger RS, Lee IM Comparison of National Death Index and World Wide Web death searches. Am J Epidemiol. 2000 Jul 15;152(2):107-11.
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.