Cocks K, Torgerson DJ Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.
Connor KM, Davidson JR Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
Elgazzar R, Nolan TS, Joseph JJ, Aboagye-Mensah EB, Azap RA, Gray DM 2nd Community-engaged and community-based participatory research to promote American Heart Association Life's Simple 7 among African American adults: A systematic review. PLoS One. 2020 Sep 1;15(9):e0238374. doi: 10.1371/journal.pone.0238374. eCollection 2020.
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484.
Leon AC, Davis LL, Kraemer HC The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
Moore CG, Carter RE, Nietert PJ, Stewart PW Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.
Sim J, Lewis M The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
Taub HA, Baker MT The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. Exp Aging Res. 1983 Fall;9(3):135-8. doi: 10.1080/03610738308258441.
Wallston KA The validity of the multidimensional health locus of control scales. J Health Psychol. 2005 Sep;10(5):623-31. doi: 10.1177/1359105305055304.
Mobile Health for Enhanced Hypertension Self-Management in Underserved Urban Residents
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.