Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges?

Susan Ellenberg discusses alternative approaches towards evaluating data as it accumulates in clinical trials, and to protecting the integrity and preventing undue risks to participants, as the trial continues.

[1]  H Merabet,et al.  The design and analysis of sequential clinical trials , 2013 .

[2]  World Bank,et al.  Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards , 2012, International Journal of Pharmaceutical Medicine.

[3]  D. Dixon,et al.  Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials , 2011, Clinical trials.

[4]  R. Klitzman.  How local IRBs view central IRBs in the US , 2011, BMC medical ethics.

[5]  J. Menikoff,et al.  The paradoxical problem with multiple-IRB review. , 2010, The New England journal of medicine.

[6]  J. Drazen,et al.  Don't mess with the DSMB. , 2010, The New England journal of medicine.

[7]  D. DeMets,et al.  Bias and trials stopped early for benefit. , 2010, Journal of the American Medical Association (JAMA).

[8]  D. Berry,et al.  Bias and trials stopped early for benefit. , 2010, JAMA.

[9]  Boris Freidlin,et al.  Bias and trials stopped early for benefit. , 2010, JAMA.

[10]  G. Guyatt,et al.  Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. , 2010, JAMA.

[11]  P. Tereskerz.  Data Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability , 2010, Accountability in research.

[12]  D. Berry,et al.  Bias and Trials Stopped Early for Benefit. Authors' reply , 2010 .

[13]  T. Mondoro.  Data safety monitoring boards: a word from a sponsor (NHLBI) , 2009, Transfusion.

[14]  M. Rabins,et al.  Vioxx and the Merck Team Effort , 2009 .

[15]  Matthias Briel,et al.  Early stopping of randomized clinical trials for overt efficacy is problematic. , 2008, Journal of clinical epidemiology.

[16]  H. Cohen,et al.  Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board , 2007, Clinical trials.

[17]  Curt D. Furberg,et al.  Data Monitoring in Clinical Trials: A Case Studies Approach , 2005 .

[18]  D. Spiegelhalter,et al.  Issues in data monitoring and interim analysis of trials. , 2005, Health technology assessment.

[19]  D. DeMets,et al.  Liability issues for data monitoring committee members , 2004, Clinical trials.

[20]  D. DeMets,et al.  The independent statistician for data monitoring committees , 2004, Statistics in medicine.

[21]  Stuart J Pocock,et al.  A major trial needs three statisticians: why, how and who? , 2004, Statistics in medicine.

[22]  J. Wittes.  Playing safe and preserving integrity: making the FDA model work , 2004, Statistics in medicine.

[23]  G. Campbell,et al.  Independence of the statistician who analyses unblinded data , 2004, Statistics in medicine.

[24]  S. George,et al.  Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? , 2004, Statistics in medicine.

[25]  D. Spiegelhalter,et al.  Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials , 2004, Clinical trials.

[26]  D. Spiegelhalter,et al.  Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study , 2004, Clinical trials.

[27]  D. Clayton,et al.  Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML12 randomization. , 2003, Controlled clinical trials.

[28]  David L. DeMets,et al.  Data Monitoring Committees in Clinical Trials: A Practical Perspective , 2002 .

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

[30]  S. Pocock,et al.  When to stop a clinical trial. , 1992, BMJ.

[31]  K. K. Lan,et al.  Discrete sequential boundaries for clinical trials , 1983 .

[32]  P. O'Brien,et al.  A multiple testing procedure for clinical trials. , 1979, Biometrics.

[33]  S. Pocock.  Group sequential methods in the design and analysis of clinical trials , 1977 .

[34]  K McPherson,et al.  Statistics: the problem of examining accumulating data more than once. , 1974, The New England journal of medicine.