FlemingTR. Historical controls, data banks and randomized trials in clinical research: a review. Cancer Treat Rep1982; 66: 1101–1105.
2.
PocockSJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis1976; 29: 175–188.
3.
ByarDPSchoenfeldDAGreenSB. Design considerations for AIDS trials. N Engl J Med1990; 323: 1343–1348.
4.
DicksonERFlemingTRWiesnerRH. Trial of penicillamine in advanced primary biliary cirrhosis. N Engl J Med1985; 312: 1011–1015.
5.
DicksonERGrambschPFlemingTR. Prognosis in primary biliary cirrhosis: model for decision making. Hepatology1989; 10: 1–7.
6.
MarkusBHDicksonERGrambschPM. Efficacy of liver transplantation in patients with primary biliary cirrhosis. N Engl J Med1989; 320: 1709–1713.
7.
FlemingTRPowersJH. Issues in noninferiority trials: the evidence in community-acquired pneumonia. Clin Infect Dis2008; 47: S108–S120.
8.
CameronEPaulingL. Supplemental ascorbate in the supportive treatment of cancer: prolongation of survival times in terminal human cancer. Proc Natl Acad Sci USA1976; 73: 3685–3689.
9.
CameronEPaulingL. Supplemental ascorbate in the supportive treatment of cancer: reevaluation of prolongation of survival times in terminal human cancer. Proc Natl Acad Sci USA1978; 75: 4538–4542.
10.
MoertelCCFlemingTRCreaganET. High dose vitamin c and placebo in the treatment of advanced cancer patients with no prior chemotherapy. A randomized double-blind comparison. N Engl J Med1985; 312: 137–141.
11.
Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative Randomized Controlled Trial. JAMA2002; 288: 321–333.
12.
FlemingTRSharplesKMcCallJ. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials2008; 5: 157–167.
13.
EllenbergSFlemingTDeMetsD. Data monitoring committees in clinical trials: a practical perspective. Chichester: John Wiley & Sons, Ltd., 2002.
SissokoDFolkessonEAbdoulM. Favipiravir in patients with Ebola virus disease: early results of the JIKI trial in Guinea. In: Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 23–26 February 2015, abstract number: 103-ALB.
17.
FlemingTR. Clinical trials: discerning hype from substance. Ann Intern Med2010; 153: 400–406.
18.
Henao-RestrepoAMLonginiIMEggerM. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial. Lancet2015; 386: 857–866.
19.
FlemingTR. Addressing missing data in clinical trials. Ann Intern Med2011; 154: 113–117.
20.
GostinL. Ethical principles for the conduct of human subject research: population-based research and ethics. Law Med Health Care1991; 19: 191–201.
21.
GuayLAMusokePFlemingT. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet1999; 354: 795–802.
22.
DorenbaumACunninghamCKGelberRD. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial. JAMA2002; 288: 189–198.
23.
CoxEBorioLTempleR. Evaluating Ebola therapies—the case for RCTs. N Engl J Med2014; 371: 2350–2351.
24.
SchieffelinJSShafferJGGobaA. Clinical illness and outcomes in patients with Ebola in Sierra Leone. N Engl J Med2014; 371: 2092–2100.
25.
AnsumanaRJacobsenKHSahrF. Ebola in Freetown area, Sierra Leone—a case study of 581 patients. N Engl J Med2015; 372: 587–588.
26.
LindbladeKAKatehFNagbeTK. Decreased Ebola transmission after rapid response to outbreaks in remote areas, Liberia, 2014. Emerg Infect Dis2015; 21: 1800–1807.
27.
US Supreme Court. UNITED STATES v. RUTHERFORD, 442 U.S. 544. UNITED STATES ET AL. v. RUTHERFORD ET AL. CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT. No. 78-605. Argued April25, 1979. Decided June18, 1979.