Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials: a practical perspective. Hoboken: John Wiley & Sons; 2003.
Google Scholar
Herson J. Data and safety monitoring committees in clinical trials. Boca Raton: Chapman & Hall/CRC/Taylor & Francis; 2009.
Book
Google Scholar
Anand SS, Wittes J, Yusuf S. What information should a sponsor of a randomized trial receive during its conduct? Clin Trials. 2011;8:716–9.
Article
PubMed
Google Scholar
Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 3rd ed. New York: Springer; 1998.
Book
Google Scholar
Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MK, Pocock SJ, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess. 2005;9:1–238. iii–iv.
Article
CAS
Google Scholar
Borer JS, Gordon DJ, Geller NL. When should data and safety monitoring committees share interim results in cardiovascular trials? JAMA. 2008;299:1710–2.
Article
CAS
PubMed
Google Scholar
Bloudoff-Indelicato M. Threat of interim data leaks prompts call for international rules. Nat Med. 2015;21:200.
Article
CAS
PubMed
Google Scholar
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. http://www.ich.org/home.html. Accessed Dec 2015.
Who we are. 2017. http://www.who.int/about/who-we-are/en/. Accessed Dec 2015.
Wong G, Greenhalgh T, Westhorp G, Buckingham J, Pawson R. RAMESES publication standards: meta-narrative reviews. BMC Med. 2013;11(1):20.
Article
PubMed
PubMed Central
Google Scholar
George SL. A survey of monitoring practices in cancer clinical trials. Stat Med. 1993;12(5-6):435–50.
Article
CAS
PubMed
Google Scholar
Geller NL, Stylianou M. Practical issues in data monitoring of clinical trials: summary of responses to a questionnaire at NIH. Stat Med. 1993;12(5-6):543–51. discussion 553.
Article
CAS
PubMed
Google Scholar
Tereskerz PM, Guterbock TM, Kermer DA, Moreno JD. An opinion and practice survey on the structure and management of data and safety monitoring boards. Account Res. 2011;18:1–30.
Article
PubMed
Google Scholar
Silverman H. Ethical issues during the conduct of clinical trials. Proc Am Thorac Soc. 2007;4:180–4. discussion 184.
Article
PubMed
Google Scholar
Slutsky AS, Lavery JV. Data safety and monitoring boards. N Engl J Med. 2004;350(11):1143–7.
Article
CAS
PubMed
Google Scholar
Fleming TR, Sharples K, McCall J, Moore A, Rodgers A, Stewart R. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials. 2008;5:157–67.
Article
PubMed
PubMed Central
Google Scholar
Rouse DJ. Data monitoring and safety committees and their operations. Obstet Gynecol Surv. 2003;58(5):329–36.
PubMed
Google Scholar
Migrino RQ, Topol EJ. A matter of life and death? The Heart Protection Study and protection of clinical trial participants. Control Clin Trials. 2003;24(5):501–5.
Article
PubMed
Google Scholar
Hemmings R, Day S. Regulatory perspectives on data safety monitoring boards: protecting the integrity of data. Drug Saf. 2004;27:1–6.
Article
PubMed
Google Scholar
US Food and Drug Administration. The establishment and operation of clinical trial data monitoring committees for clinical trial sponsors. Rockville: US Food and Drug Administration; 2006. p. 38.
Google Scholar
Eckstein L. Building a more connected DSMB: better integrating ethics review and safety monitoring. Account Res Policies Qual Assur. 2015;22(2):81–105.
Google Scholar
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Harmonised tripartite guideline; statistical principles for clinical trials E9. Geneva: ICH; 1998. p. 39.
Chalmers I, Altman DG, McHaffie H, Owens N, Cooke RW. Data sharing among data monitoring committees and responsibilities to patients and science. Trials. 2013;14:102.
Article
PubMed
PubMed Central
Google Scholar
Shah SK, Dawson L, Dixon DO, Lie RK. Should sponsors and DSMBs share interim results across trials? J Acquir Immune Defic Syndr. 2011;58(5):433–5.
Article
PubMed
PubMed Central
Google Scholar
US Food and Drug Administration. FDA guidance on clinical trial data monitoring committees (DMCs). Rockville: US Food and Drug Administration; 2001. p. 237.
Google Scholar
Pocock SJ. Statistical and ethical issues in monitoring clinical trials. Stat Med. 1993;12(15-16):1459–69. discussion 1471–5.
Article
CAS
PubMed
Google Scholar
Chow SC, Corey R, Lin M. On the independence of data monitoring committee in adaptive design clinical trials. J Biopharm Stat. 2012;22(4):853–67.
Article
PubMed
Google Scholar
Fleming TR, Hennekens CH, Pfeffer MA, DeMets DL. Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials. J Biopharm Stat. 2014;24(5):968–75.
Article
PubMed
PubMed Central
Google Scholar
D’Agostino Sr RB. The statistician and the data monitoring committee. Stat Med. 2004;23(10):1501–2.
Article
PubMed
Google Scholar
Fleming TR. Standard versus adaptive monitoring procedures: a commentary. Stat Med. 2006;25(19):3305–12. discussion 3313–4, 3326–47.
Article
PubMed
Google Scholar
Siegel JP, O’Neill RT, Temple R, Campbell G, Foulkes MA. Independence of the statistician who analyses unblinded data. Stat Med. 2004;23(10):1527–9.
Article
PubMed
Google Scholar
NHLBI policy for data and safety monitoring of extramural clinical studies. http://www.nhlbi.nih.gov/research/funding/human-subjects/data-safety-monitoring-policy. Accessed Dec 2015.
Guidelines for NCCIH-appointed data and safety monitoring boards. https://nccih.nih.gov/research/policies/datasafety. Accessed Dec 2015.
Sartor O, Halabi S. Independent data monitoring committees: an update and overview. Urol Oncol. 2015;33(3):143–8.
Article
PubMed
PubMed Central
Google Scholar
Williams GW, Davis RL, Getson AJ, Gould AL, Hwang IK, Matthews H, Shih WCJ, Snapinn SM, Waltonbowen KL. Monitoring of clinical trials and interim analyses from a drug sponsors point of view. Stat Med. 1993;12(5-6):481–92.
Article
CAS
PubMed
Google Scholar
DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P, Julian D, Kaplan R, Levine R, Neaton J, et al. Issues in regulatory guidelines for data monitoring committees. Clin Trials. 2004;1(2):162–9.
Article
PubMed
Google Scholar
Delgado-Herrera L, Anbar D. A model for the interim analysis process: a case study. Control Clin Trials. 2003;24:51–65.
Article
PubMed
Google Scholar
DeMets DL, Fleming TR. The independent statistician for data monitoring committees. Stat Med. 2004;23(10):1513–7.
Article
PubMed
Google Scholar
Stephens RJ, Langley RE, Mulvenna P, Nankivell M, Vail A, Parmar MK. Interim results in clinical trials: do we need to keep all interim randomised clinical trial results confidential? Lung Cancer. 2014;85(2):116–8.
Article
CAS
PubMed
Google Scholar
Green S, Crowley J. Data monitoring committees for Southwest Oncology Group clinical trials. Stat Med. 1993;12(5-6):451–5.
Article
CAS
PubMed
Google Scholar
Lilford RJ, Braunholtz D, Edwards S, Stevens A. Monitoring clinical trials - interim data should be publicly available. Br Med J. 2001;323(7310):441–2.
Article
CAS
Google Scholar
Miller FG, Wendler D. Is it ethical to keep interim findings of randomised controlled trials confidential? J Med Ethics. 2008;34:198–201.
Article
CAS
PubMed
Google Scholar
Vail A, Hornbuckle J, Spiegelhalter DJ, Thornton JG. Prospective application of Bayesian monitoring and analysis in an ‘open’ randomized clinical trial. Stat Med. 2001;20(24):3777–87.
Article
CAS
PubMed
Google Scholar
Fleming TR, Ellenberg S, DeMets DL. Monitoring clinical trials: issues and controversies regarding confidentiality. Stat Med. 2002;21(19):2843–51.
Article
PubMed
Google Scholar
Glover JM, Kay R. Who advises the Data Monitoring Committee (DMC)? A review of regulatory guidance for sponsors on DMCs after 5 years and advice for DMC members. Drug Inf J. 2012;46(5):525–31.
Google Scholar
Califf RM, Ellenberg SS. Statistical approaches and policies for the operations of Data and Safety Monitoring Committees. Am Heart J. 2001;141(2):301–5.
Article
CAS
PubMed
Google Scholar
Hicks LK, Laupacis A, Slutsky AS. A primer on data safety monitoring boards: mission, methods, and controversies. Intensive Care Med. 2007;33(10):1815–8.
Article
PubMed
Google Scholar
DeMets DL. Relationships between Data Monitoring Committees. Control Clin Trials. 2000;21(1):54–5.
Article
Google Scholar
Dixon DO, Lagakos SW. Should data and safety monitoring boards share confidential interim data? Control Clin Trials. 2000;21:1–6. discussion 54–55.
Article
CAS
PubMed
Google Scholar
Dixon DO, Weiss S, Cahill K, Fox L, Love J, McNamara J, Soto-Torres LE. Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials. Clin Trials. 2011;8:727–35.
Article
PubMed
Google Scholar
Yusuf, Whitley R, Assenzo R, Fleming T, Deykin, Hawkins B, Meier, Gent, Tognoni, Ellenberg J, et al. The operation of data monitoring committees - discussion. Stat Med. 1993;12(5-6):527–42.
Article
Google Scholar
Ellenberg SS. Independent data monitoring committees: rationale, operations and controversies. Stat Med. 2001;20:2573–83.
Article
CAS
PubMed
Google Scholar
Wittes J, Barrett-Connor E, Braunwald E, Chesney M, Cohen HJ, Demets D, Dunn L, Dwyer J, Heaney RP, Vogel V, et al. Monitoring the randomized trials of the Women’s Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials. 2007;4:218–34.
Article
PubMed
Google Scholar
Peppercorn J, Buss WG, Fost N, Godley PA. The dilemma of data-safety monitoring: provision of significant new data to research participants. Lancet. 2008;371(9611):527–9.
Article
PubMed
Google Scholar
Fleming TR. Protecting the confidentiality of interim data: addressing current challenges. Clin Trials. 2015;12(1):5–11.
Article
PubMed
Google Scholar
Nissen SE. Commentary: confidentiality of interim trial data—the emerging crisis. Clin Trials. 2015;12(1):15–7.
Article
PubMed
Google Scholar
US Food and Drug Administration, Department of Health and Human Services, Parks M, Rosebraugh C, Jenkins J, Woodcock J. Memorandum; disclosure of interim cardiovascular risk study data NDA 22271 Nesina (alogliptin) tablets and its fixed dose combination product NDAs 22426 and 203414. Rockville: US Food and Drug Administration; 2013.
Google Scholar
US Food and Drug Administration. Presentations for: Part 15 public hearing; confidentiality of interim results in cardiovascular (CV) outcomes safety trials. Rockville: US Food and Drug Administration; 2014.
Google Scholar
London AJ. Commentary: data monitoring confidentiality and FDA transparency. Clin Trials. 2015;12(1):12–4.
Article
PubMed
Google Scholar
US Food and Drug Administration. Transcript for hearing: Part 15 public hearing; confidentiality of interim results in cardiovascular (CV) outcomes safety trials. Rockville: US Food and Drug Administration; 2014.
Google Scholar
Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials; Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER; Request for Comments. http://www.fda.gov/Drugs/NewsEvents/ucm405023.htm. Accessed Dec 2015.
Gallo P. Operational challenges in adaptive design implementation. Pharm Stat. 2006;5(2):119–24.
Article
PubMed
Google Scholar
Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J. Adaptive designs in clinical drug development—an Executive Summary of the PhRMA Working Group. J Biopharm Stat. 2006;16(3):275–83. discussion 285–91, 293–8, 311–2.
Article
PubMed
Google Scholar
Gallo P. Confidentiality and trial integrity issues for adaptive designs. Drug Inf J. 2006;40(4):445–50.
Google Scholar
Herson J. Coordinating data monitoring committees and adaptive clinical trial designs. Drug Inf J. 2008;42(4):297–301.
Google Scholar
Antonijevic Z, Gallo P, Chuang-Stein C, Dragalin V, Loewy J, Menon S, Miller ER, Morgan CC, Sanchez M. Views on emerging issues pertaining to data monitoring committees for adaptive trials. Ther Innov Regul Sci. 2013;47(4):495–502.
Article
Google Scholar
Day S. Data monitoring committees in clinical trials: best practice, complexities and considerations. Clin Invest. 2015;5(7):615–7.
Article
CAS
Google Scholar
Gallo P, Fardipour P, Dragalin V, Krams M, Littman GS, Bretz F. Data monitoring in adaptive dose-ranging trials. Stat Biopharm Res. 2010;2(4):513–21.
Article
Google Scholar
Korn EL, Hunsberger S, Freidlin B, Smith MA, Abrams JS. Preliminary data release for randomized clinical trials of noninferiority: a new proposal. J Clin Oncol. 2005;23:5831–6.
Article
PubMed
Google Scholar
Allardyce RA, Bagshaw PF, Frampton CM, Frizelle FA, Hewett PJ, Rieger NA, Smith JS, Solomon MJ, Stevenson AR. Ethical issues with the disclosure of surgical trial short-term data. ANZ J Surg. 2011;81(3):125–31.
Article
PubMed
Google Scholar
DeMets DL. Commentary on Anand et al. Clin Trials. 2011;8:722–3. discussion 726.
Article
PubMed
Google Scholar
Rockhold FW, Enas GG. Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. Stat Med. 1993;12(5-6):471–9.
Article
CAS
PubMed
Google Scholar
DeMets DL, Fleming TR, Whitley RJ, Childress JF, Ellenberg SS, Foulkes M, Mayer KH, O’Fallon J, Pollard RB, Rahal JJ, et al. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials. 1995;16:408–21.
Article
CAS
PubMed
Google Scholar
Smith MA, Ungerleider RS, Korn EL, Rubinstein L, Simon R. Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute. J Clin Oncol. 1997;15(7):2736–43.
Article
CAS
PubMed
Google Scholar