NCRR creates new GCRC research subject ombudsman position. J Investig Med2001;49222.
6.
PocockS, FurbergCD.Procedures of data and safety monitoring committees. Am Heart J2001;141:289–294.
7.
WittesJ.Behind closed doors: The data monitoring board in randomized clinical trials. Stat Med1993;12:419–424.
8.
CaliffRM, EllenbergSS.Statistical approaches and policies for the operations of Data and Safety Monitoring Committees. Am Heart J2001;141:301–305.
9.
DeMetsDL, PocockSJ, JulianDG.The agonising negative trend in monitoring of clinical trials. Lancet1999;354:1983–1988.
10.
BollandK, WhiteheadJ.Formal approaches to safety monitoring of clinical trials in life-threatening conditions. Stat Med2000;19:2899–2917.
11.
PocockSJ.When to stop a clinical trial. BMJ1992;305:235–240.
12.
PackerM, WittesJ, StumpD.Terms of reference for data and safety monitoring committees. Am Heart J2001;141:542–547.
13.
ZelenM.Early stopping, interim analyses, and monitoring committees: What are the tradeoffs?J Clin Oncol1987;5:1314–1315.
14.
EchtDS, LiebsonPR, MitchellLB, PetersRW, Obias-MannoD, BarkerAH, ArensbergD, BakerA, FriedmanL, GreeneHL, . Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med1991;324:781–788.
15.
Branched-chain amino acids and amyotrophic lateral sclerosis: A treatment failure?The Italian ALS Study Group. Neurology 1993;432466–2470.
16.
McKenzieR, FriedMW, SallieR, ConjeevaramH, Di BisceglieAM, ParkY, SavareseB, KleinerD, TsokosM, LucianoC, . Hepatic failure and lactic acidosis due to fialuridine (FIAU), an investigational nucleoside analogue for chronic hepatitis B. N Engl J Med1995;333:1099–1105.
17.
Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl J Med1989;321406–412.
18.
PawitanY, HallstromA.Statistical interim monitoring of the Cardiac Arrhythmia Suppression Trial. Stat Med1990;9:1081–1090.
19.
MeinertCL, KnatterudGL, ProutTE, KlimtCR.A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. Diabetes1970;19:789–830.
FriedelD, ThomasR, FisherRS.Ischemic colitis during treatment with alosetron. Gastroenterology2001;120:557–560.
22.
FriedmanMA, WoodcockJ, LumpkinMM, ShurenJE, HassAE, ThompsonLJ.The safety of newly approved medicines: Do recent market removals mean there is a problem?JAMA1999;281:1728–1734.
23.
CairnsJA, HallstromA, HeldP.Should all trials have a data safety and monitoring committee?Am Heart J2001;141:156–163.
24.
GreenSJ, FlemingTR,O'FallonJR. Policies for study monitoring and interim reporting of results. J Clin Oncol1987;5:1477–1484.