Bouman AC, ten Cate-Hoek AJ, Ramaekers BL, Joore MA Sample Size Estimation for Non-Inferiority Trials: Frequentist Approach versus Decision Theory Approach. PLoS One. 2015 Jun 15;10(6):e0130531. doi: 10.1371/journal.pone.0130531. eCollection 2015.
Chebli JM, Gaburri PD, Chebli LA Oral refeeding in mild acute pancreatitis: an old challenge. World J Gastrointest Pathophysiol. 2011 Dec 15;2(6):100-2. doi: 10.4291/wjgp.v2.i6.100.
Eckerwall GE, Tingstedt BB, Bergenzaun PE, Andersson RG Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery--a randomized clinical study. Clin Nutr. 2007 Dec;26(6):758-63. Epub 2007 Aug 24.
Li JY, Yu T, Chen GC, Yuan YH, Zhong W, Zhao LN, Chen QK Enteral nutrition within 48 hours of admission improves clinical outcomes of acute pancreatitis by reducing complications: a meta-analysis. PLoS One. 2013 Jun 6;8(6):e64926. doi: 10.1371/journal.pone.0064926. Print 2013.
Marik PE What is the best way to feed patients with pancreatitis? Curr Opin Crit Care. 2009 Apr;15(2):131-8. doi: 10.1097/MCC.0b013e328319910a. Review.
McClave SA, Heyland DK The physiologic response and associated clinical benefits from provision of early enteral nutrition. Nutr Clin Pract. 2009 Jun-Jul;24(3):305-15. doi: 10.1177/0884533609335176. Review.
Meng WB, Li X, Li YM, Zhou WC, Zhu XL Three initial diets for management of mild acute pancreatitis: a meta-analysis. World J Gastroenterol. 2011 Oct 7;17(37):4235-41. doi: 10.3748/wjg.v17.i37.4235.
Moraes JM, Felga GE, Chebli LA, Franco MB, Gomes CA, Gaburri PD, Zanini A, Chebli JM A full solid diet as the initial meal in mild acute pancreatitis is safe and result in a shorter length of hospitalization: results from a prospective, randomized, controlled, double-blind clinical trial. J Clin Gastroenterol. 2010 Aug;44(7):517-22. doi: 10.1097/MCG.0b013e3181c986b3.
Working Group IAP/APA Acute Pancreatitis Guidelines IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
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.
