Evaluation and Review of Strategies to Assess Cardiovascular Risk in Clinical Trials in Patients with Type 2 Diabetes Mellitus

REFERENCES

• Committee for Medicinal Products for Human Use (CHMP) (2012), `` Guideline on Clinical Investigation of Medicinal Products in the Treatment or Prevention of Diabetes Mellitus,’’ . available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129256.pdf
   Google Scholar
• FDA Guidance to Industry (2008), `` Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,’’ available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf
   Google Scholar
• FDA Guidance to Industry (DMC Guidance) (2006), ``Establishment and Operation of Clinical Trial Data Monitoring Committees,’’ available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127073.pdf
   Google Scholar
• Geiger, M.J., Mehta, C., Turner, J. R., Arbet-Engels, C., Hantel, S., Hirshberg, B., Koglin, J., Mendzelevski, B., Sager, P. T., Shapiro, D., Stewart, M., Todaro, T. G., and Gaydos, B. (2015), “Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes,” Therapeutic Innovation and Regulatory Science, 49, 50–64.
   Google Scholar
• Green, J.B., Bethel, M.A., Paul, S.K., Ring, A., Kaufman, K.D., Shapiro, D.R., Califf, R.M., and Holman, R.R. (2013), “Rationale, Design, and Organization of A Randomized, Controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in Patients With Type 2 Diabetes and Established Cardiovascular Disease,” American Heart Journal, 166, 983–989.
   Google Scholar
• Hennekens, C.H., and DeMets, D. (2009), “The Need for Large Scale Randomized Evidence Without Undue Emphasis on Small Trials, Their Metaanalyses or Subgroup Analyses,” The Journal of the American Medical Association, 302, 2361–2362.
   Google Scholar
• Hoaglin, D.C., Hawkins, N., Jansen, J.P., Scott, D.A., Itzler, R., Cappelleri, J.C., Boersma, C., Thompson, D., Larholt, K.M., Diaz, M., and Barrett, A. (2011), “Conduct Indirect-Treatment-Comparison and Network-Meta-Analysis Studies: Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices—Part 2,” Value in Health, 14, 429–437.
   Google Scholar
• Home, P.D., Pocock, S.J., Beck-Nielsen, H., Curtis, P.S., Gomis, R., Hanefeld, M., Jones, N. P., Komajda, M., McMurray, J. J. (2009), “Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD): A Multicentre, Randomised, Open-Label Trial,” Lancet, 373, 2125–2135.
   Google Scholar
• Jansen, J.P., Trikalinos, T., Cappelleri, J.C., Daw, J., Andes, S., Eldessouki, R., and Salanti, G. (2014), “Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: An ISPOR-AMCP-NPC Good Practice Task Force Report,” Value in Health, 17, 157–173.
   Google Scholar
• Jansen, J.P., Fleurence, R., Devine, B., Itzler, R., Barrett, A., Hawkins, N., Lee, K., Boersma, C., Annemans, L., and Cappelleri, J.C. (2011), “Interpreting Indirect Treatment Comparisons and Network Meta-Analysis for Health-Care Decision Making. Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: Part I,” Value in Health, 14, 417–428.
   Google Scholar
• Jennison, C., and Turnbull, B.W. (2000), Group Sequential Methods with Applications to Clinical Trials, Boca Raton, FL: Chapman & Hall.
   Google Scholar
• Madigan, D., Ryan, P.B., and Schuemie, M. “Does Design Matter? Systematic Evaluation of the Impact of Analytical Choices on Effect Estimates in Observational Studies,” Therapeutic Advances in Drug Safety, 4, 53–62.
   Google Scholar
• Nissen, S.E., and Wolski, K. (2007), “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death From Cardiovascular Causes,” The New England Journal of Medicine, 356, 2457–2471.
   Google Scholar
• Nissen, S.E., Wolski, K., and Topol, E.J. (2005), “Effect of Muraglitazar on Death and Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes Mellitus,” The Journal of the American Medical Association, 294, 2581–2586.
   Google Scholar
• Tian, L., Cai, T., Pfeffer, M. A., Piankov, N., Cremieux, P. Y., and Wei, L. J. (2009), “Exact and Efficient Inference Procedure for Meta-Analysis and its Application to the Analysis of Independent 2×2 Tables with All Available Data but Without Artificial Continuity Correction,” Biostatistics, 10, 275–281.
   Google Scholar