Bailey DJ, Eatchel K, Wambaugh J Sound Production Treatment: Synthesis and Quantification of Outcomes. Am J Speech Lang Pathol. 2015 Nov;24(4):S798-814. doi: 10.1044/2015_AJSLP-14-0127.
Mauszycki SC, Bailey DJ, Wambaugh JL Acquired Apraxia of Speech: The Relationship Between Awareness of Errors in Word Productions and Treatment Outcomes. Am J Speech Lang Pathol. 2017 Jun 22;26(2S):664-673. doi: 10.1044/2017_AJSLP-16-0111.
Wambaugh J, Nessler C, Wright S, Mauszycki S, DeLong C Sound production treatment for acquired apraxia of speech: Effects of blocked and random practice on multisyllabic word production. Int J Speech Lang Pathol. 2016 Oct;18(5):450-64. doi: 10.3109/17549
Wambaugh JL, Nessler C, Cameron R, Mauszycki SC Treatment for acquired apraxia of speech: examination of treatment intensity and practice schedule. Am J Speech Lang Pathol. 2013 Feb;22(1):84-102. doi: 10.1044/1058-0360(2012/12-0025). Epub 2012 Oct 15.
Wambaugh JL, Nessler C, Wright S, Mauszycki SC Sound production treatment: effects of blocked and random practice. Am J Speech Lang Pathol. 2014 May;23(2):S225-45. doi: 10.1044/2014_AJSLP-13-0072.
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.
