A joint industry‐sponsored data monitoring committee model for observational, retrospective drug safety studies in the real‐world setting

To share better practice in establishing data monitoring committees (DMCs) for observational, retrospective safety studies with joint‐industry sponsorship.

[1]  H. Howe.  North American Association of Central Cancer Registries , 2020, Definitions.

[2]  Jonathan H Seltzer,et al.  The changing landscape of data monitoring committees—Perspectives from regulators, members, and sponsors , 2018, Biometrical journal. Biometrische Zeitschrift.

[3]  D. DeMets,et al.  Data Monitoring Committees: Current issues , 2018, Clinical trials.

[4]  D. DeMets,et al.  Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative , 2017, Clinical trials.

[5]  L. Lund,et al.  Registry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions , 2017, Current Heart Failure Reports.

[6]  D. DeMets,et al.  Data Monitoring Committees - Expect the Unexpected. , 2016, The New England journal of medicine.

[7]  Jonathan H Seltzer,et al.  Responsibilities of Data Monitoring Committees: Consensus Recommendations , 2016, Therapeutic innovation & regulatory science.

[8]  Daniel L Gillen,et al.  Data monitoring committees for pragmatic clinical trials , 2015, Clinical trials.

[9]  D. DeMets,et al.  Enhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials , 2014, Journal of biopharmaceutical statistics.

[10]  Christy Chuang-Stein,et al.  A Practical Guide to Data Monitoring Committees in Adaptive Trials , 2014, Therapeutic innovation & regulatory science.

[11]  A. Carlsson,et al.  When is it safe to stop for safety? , 2012, Journal of thrombosis and haemostasis : JTH.

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

[13]  D. Cook,et al.  Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis. , 2009, Journal of critical care.

[14]  D. Moher,et al.  Improving the reporting of pragmatic trials: an extension of the CONSORT statement , 2008, BMJ : British Medical Journal.

[15]  Arthur S Slutsky,et al.  A primer on data safety monitoring boards: mission, methods, and controversies , 2007, Intensive Care Medicine.

[16]  S. Goodman.  Stopping at Nothing? Some Dilemmas of Data Monitoring in Clinical Trials , 2007, Annals of Internal Medicine.

[17]  L. Burgio,et al.  Data and safety monitoring in social behavioral intervention trials: the REACH II experience , 2006, Clinical trials.

[18]  Sydes,et al.  A proposed charter for clinical trial data monitoring committees: helping them to do their job well , 2005, The Lancet.

[19]  D. Lilienfeld.  Pharmacoepidemiology 101: data monitoring committees in the post‐marketing approval setting , 2004, Pharmacoepidemiology and drug safety.

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

[21]  D. DeMets,et al.  Issues in regulatory guidelines for data monitoring committees , 2004, Clinical trials.

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

[23]  D. DeMets,et al.  The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. , 1995, Controlled clinical trials.

[24]  John B. Watkins,et al.  Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making. , 2017, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[25]  Guideline on good pharmacovigilance practices ( GVP ) Module , 2013 .

[26]  I NHI,et al.  Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. , 1988, Controlled clinical trials.

[27]  J. Lellouch,et al.  Explanatory and pragmatic attitudes in therapeutical trials. , 1967, Journal of chronic diseases.