University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding data and safety monitoring committees in clinical trials (afternoon panel session)

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References

Greenhouse

SW.

Halperin, Max. In: Balakrishnan

Colton

Everitt

et al . (eds) Wiley StatsRef: statistics reference online. John Wiley & Sons, 2014. https://onlinelibrary.wiley.com/doi/pdf/10.1002/9781118445112.tat04794 (Accessed June 4, 2018).

Wei

Lachin

JM.

Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J Am Stat Assoc 1984; 79: 653–661.

Frick

A maxmin linear test of normal means and its application to Lachin’s data. Commun Stat Theory Methods 1994; 23: 1021–1029.

Lachin

JM.

Applications of the Wei-Lachin multivariate one-sided test for multiple outcomes on possibly different scales. PLoS ONE 2014; 9: e108784.

Lachin

Bebu

Application of the Wei-Lachin multivariate one-directional test to multiple event-time outcomes. Clin Trials 2015; 12: 627–633.

The PEACE Trial Investigators. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med. 2004; 351: 2058–2068.

ClinicalTrials.gov. Prevention of events with angiotensin-converting enzyme inhibitor therapy (PEACE), https://clinicaltrials.gov/ct2/show/NCT00000558 2005, (Accessed 7 May 2018).

Pocock

Ariti

Collier

et al . The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J 2012; 33: 176–182.

Bebu

Lachin

JM.

Large sample inference for a win ratio analysis of a composite outcome based on prioritized components. Biostatistics 2016; 17: 178–187.

10.

Marshall

Olkin

A multivariate exponential distribution. J Am Stat Assoc 1967; 62: 30–44.

11.

Rid

Wendler

A framework for risk-benefit evaluations in biomedical research. Kennedy Inst Ethics J 2011; 21: 141–179.

12.

Wittes

Barrett-Connor

Braunwald

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: 218–234.

13.

Evans

Rubin

Follmann

et al . Desirability of outcome ranking (DOOR) and response adjusted for duration of antibiotic risk (RADAR). Clin Infect Dis 2015; 61: 800–806.

14.

Evans

Follmann

Using outcomes to analyze patients rather than patients to analyze outcomes: a step toward pragmatism in benefit:risk evaluation. Stat Biopharm Res 2016; 8: 386–393.

15.

Saldanha

Yang

et al . Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS. J Clin Epidemiol 2017; 84: 85–94.

16.

Steering Committee of the Physicians’ Health Study Research Group. Preliminary report: findings from the aspirin component of the Ongoing Physicians’ Health Study. N Engl J Med 1988; 318: 262–264.

17.

Greenhouse

. Cornfield, Jerome. In: Encyclopedia of biostatistics. John Wiley & Sons, 2005. https://onlinelibrary.wiley.com/doi/full/10.1002/0470011815.b2a170322005 Accessed June 4, 2018)

18.

ClinicalTrials.gov. Cardiac arrhythmia suppression trial (CAST), https://clinicaltrials.gov/ct2/show/NCT00000526 (2016, accessed 7 May 2018).

19.

Berk

Goldberg

Donovan

et al . Therapeutic recommendations in polycythemia vera based on Polycythemia Vera Study Group protocols. Semin Hematol 1986; 23: 132–143.

20.

Berk

Goldberg

Silverstein

et al . Increased incidence of acute leukemia in polycythemia vera associated with chlorambucil therapy. N Engl J Med 1981; 304: 441–447.

21.

https://clinicaltrials.gov/ct2/show/NCT03134196 (Accessed 4 June 2018).

22.

Kimmel

French

Kasner

et al . A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med 2013; 369: 2283–2293.

23.

US Department of Health & Human Services, Office for Human Research Protections. Unanticipated problems involving risks & adverse events guidance (2007), https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-data-and-safety-monitoring-extramural-clinical-studies (Accessed 5 June 2018).

24.

National Institutes of Health (NIH), https://humansubjects.nih.gov/data_safetydata-and-safety-monitoring-board-guidelines (Accessed 4 April 2018).

25.

Friedman

Furberg

DeMets

Reboussin

Granger

CB.

Fundamentals of Clinical Trials, 5th Edition, Springer, 2015, p 452