Evaluating interventions for Ebola: The need for randomized trials

The Ebola outbreak in West Africa in 2014 increased recognition of the need for effective and safe interventions for the prevention and treatment of the severe and often fatal illness caused by infection with Ebola virus. Randomized clinical trials, preferably conducted in a blinded manner, provide the most reliable insights about the benefits and risks of strategies to reduce the clinical burden of Ebola-related illness.

[1]  L. Pauling,et al.  Supplemental ascorbate in the supportive treatment of cancer: reevaluation of prolongation of survival times in terminal human cancer. , 1978, Proceedings of the National Academy of Sciences of the United States of America.

[2]  Thomas R Fleming,et al.  Clinical Trials: Discerning Hype From Substance , 2010, Annals of Internal Medicine.

[3]  Charles Kooperberg,et al.  Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. , 2002, JAMA.

[4]  William Wright,et al.  United States v , 1922 .

[5]  K. Jacobsen,et al.  Ebola in Freetown area, Sierra Leone--a case study of 581 patients. , 2015, The New England journal of medicine.

[6]  P. Grambsch,et al.  Efficacy of liver transplantation in patients with primary biliary cirrhosis. , 1989, The New England journal of medicine.

[7]  T R Fleming,et al.  Trial of penicillamine in advanced primary biliary cirrhosis. , 1985, The New England journal of medicine.

[8]  Dorothy Bray,et al.  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 , 1999, The Lancet.

[9]  T. Fleming,et al.  Issues in noninferiority trials: the evidence in community-acquired pneumonia. , 2008, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[10]  L. Gostin Ethical Principles for the Conduct of Human Subject Research: Population-Based Research and Ethics , 1991, Law, medicine & health care : a publication of the American Society of Law & Medicine.

[11]  D P Byar,et al.  Design considerations for AIDS trials. , 1990, The New England journal of medicine.

[12]  John-Arne Røttingen,et al.  Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial , 2015, The Lancet.

[13]  T R Fleming,et al.  Historical controls, data banks, and randomized trials in clinical research: a review. , 1982, Cancer treatment reports.

[14]  T. Fleming Addressing Missing Data in Clinical Trials , 2011, Annals of Internal Medicine.

[15]  Patricia M. Grambsch,et al.  Data Monitoring Committees in Clinical Trials: A Practical Perspective. , 2003 .

[16]  L. Pauling,et al.  Supplemental ascorbate in the supportive treatment of cancer: Prolongation of survival times in terminal human cancer. , 1976, Proceedings of the National Academy of Sciences of the United States of America.

[17]  K. Lindblade,et al.  Decreased Ebola Transmission after Rapid Response to Outbreaks in Remote Areas, Liberia, 2014 , 2015, Emerging infectious diseases.

[18]  R. Gelber,et al.  Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial. , 2002, JAMA.

[19]  T. Fleming,et al.  High-dose vitamin C versus placebo in the treatment of patients with advanced cancer who have had no prior chemotherapy. A randomized double-blind comparison. , 1985, The New England journal of medicine.

[20]  S J Pocock,et al.  The combination of randomized and historical controls in clinical trials. , 1976, Journal of chronic diseases.

[21]  R. Temple,et al.  Evaluating Ebola therapies--the case for RCTs. , 2014, The New England journal of medicine.

[22]  David L. DeMets,et al.  Data Monitoring Committees in Clinical Trials , 2002 .

[23]  P. Grambsch,et al.  Prognosis in primary biliary cirrhosis: Model for decision making , 1989, Hepatology.

[24]  A. Unlu,et al.  High-dose vitamin C and cancer , 2016 .

[25]  Rachel S. G. Sealfon,et al.  Clinical illness and outcomes in patients with Ebola in Sierra Leone. , 2014, The New England journal of medicine.

[26]  T. Fleming,et al.  Maintaining confidentiality of interim data to enhance trial integrity and credibility , 2008, Clinical trials.