Smith GC, Pell JP, Dobbie R Birth order, gestational age, and risk of delivery related perinatal death in twins: retrospective cohort study. BMJ. 2002 Nov 2;325(7371):1004.
Smith GC, Shah I, White IR, Pell JP, Dobbie R Mode of delivery and the risk of delivery-related perinatal death among twins at term: a retrospective cohort study of 8073 births. BJOG. 2005 Aug;112(8):1139-44.
Smith GC Perinatal death in twins. Author's reply on absolute risk. BMJ. 2007 Apr 14;334(7597):762.
National Prospective and Comparative Study on the Mode of Delivery of Twins
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.
