Boukydis CF, Bigsby R, Lester BM Clinical use of the Neonatal Intensive Care Unit Network Neurobehavioral Scale. Pediatrics. 2004 Mar;113(3 Pt 2):679-89.
Das A, Poole WK, Bada HS A repeated measures approach for simultaneous modeling of multiple neurobehavioral outcomes in newborns exposed to cocaine in utero. Am J Epidemiol. 2004 May 1;159(9):891-9.
Gauthier SM, Bauer CR, Messinger DS, Closius JM The Bayley Scales of Infant Development. II: Where to start? J Dev Behav Pediatr. 1999 Apr;20(2):75-9. Erratum in: J Dev Behav Pediatr 1999 Jun;20(3):197.
Lester BM, Tronick EZ History and description of the Neonatal Intensive Care Unit Network Neurobehavioral Scale. Pediatrics. 2004 Mar;113(3 Pt 2):634-40.
Lester BM The Maternal Lifestyles Study. Ann N Y Acad Sci. 1998 Jun 21;846:296-305.
Stone KC, High PC, Miller-Loncar CL, Lagasse LL, Lester BM Longitudinal study of maternal report of sleep problems in children with prenatal exposure to cocaine and other drugs. Behav Sleep Med. 2009;7(4):196-207. doi: 10.1080/15402000903190108.
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.