A Quantitative Process for Enhancing End of Phase 2 Decisions

References

• Arrowsmith, J. (2011a), “Trial Watch: Phase III and Submission Failures: 2007–2010,” Nature Reviews Drug Discovery, 10, 87.
   PubMed Web of Science ®Google Scholar
• ——— (2011b), “Trial Watch: Phase II and Submission Failures: 2008–2010,” Nature Reviews Drug Discovery, 10, 328–329.
   Google Scholar
• DiMasi, J.A., Feldman, L., Seckler, A., and Wilson, A. (2012), “Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs,” Clinical Pharmacology & Therapeutics, 87, 272–277.
   Google Scholar
• Guyot, P., Ades, A., Ouwens, M.J. N. M., and Welton, M.J. (2012), “Enhanced Secondary Analysis of Survival Data. Reconstructing the Data From Published Survival Curves,” BMC Medical Research Methodology, 12, 9.
   PubMed Web of Science ®Google Scholar
• Higgins, J.P. T., and Green, S. (2011), “Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [Updated March 2011],” The Cochrane Collaboration. Available at www.cochrane-handbook.org.
   Google Scholar
• Hong, S., and Shi, L. (2012), “Predictive Power to Assist Phase 3 Go/No Go Decision Based Upon Phase 2 Data on a Different Endpoint,” Statistics in Medicine, 31, 831–843.
   PubMedGoogle Scholar
• Kirby, S., Burke, J., Chuang-Stein, C., and Sin, C. (2012), “Discounting Phase 2 Results When Planning Phase 3 Clinical Trials,” Pharmaceutical Statistics, 11, 373–385.
   PubMed Web of Science ®Google Scholar
• Kola, I., and Landis, J. (2004), “Can the Pharmaceutical Industry Reduce Attrition Rates?” Nature Reviews Drug Discovery, 3, 711–716.
   PubMed Web of Science ®Google Scholar
• Lambert, P.C., Sutton, A.J., Burton, P.R., Abrams, K.R., and Jones, D.R. (2005), “How Vague is Vague? Simulations Study of the Impact of the Use of Vague Prior Distributions in MCMC Using WinBUGS,” Statistics in Medicine, 24, 2401–2428.
   PubMed Web of Science ®Google Scholar
• Moher, D., Liberati, A., Tetzlaff, J., and Altman, D.G. (2009) “The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement,” British Medical Journal, 339, 332–336.
   Web of Science ®Google Scholar
• Nixon, R.M., Bansback, N., Stevens, J.W., Brennan, A., and Madan, J. (2009a), “Using Short Term Evidence to Predict Six-Month Outcomes in Clinical Trials of Signs and Symptoms in Rheumatoid Arthritis,” Pharmaceutical Statistics, 8, 150–162.
   PubMed Web of Science ®Google Scholar
• Nixon, R.M., O’Hagan, A., Oakley, J., Madan, J., Stevens, J.W., Bansback, N., and Brennan, A. (2009b), “The Rheumatoid Arthritis Drug Development Model: A Case Study in Bayesian Clinical Trial Simulation,” Pharmaceutical Statistics, 8, 371–389.
   PubMed Web of Science ®Google Scholar
• O’Hagan, A., Stevens, J.W., and Campbell, M.J. (2005), “Assurance in Clinical Trial Design,” Pharmaceutical Statistics, 4, 187–201.
   Web of Science ®Google Scholar
• Paul, S.M., Mytelka, D.S., Dunwiddie, C.T., Persinger, C.C., Munos, B.H., Lindborg, S.R., and Schacht, A.L. (2010), “How to Improve R&D Productivity: The Pharmaceutical Industry's Grand Challenge.” Nature Reviews Drug Discovery, 9, 203–214.
   PubMed Web of Science ®Google Scholar
• Sargent, D.J., Wieand, H.S., Haller, D.G., Gray, R., Benedetti, J.K., Buyse, M., Labianca, R., Seitz, J.F., O’Callaghan, C.J., Francini, G., Grothey, A., O’Connell, M., Catalano, P.J., Blanke, C.D., Kerr, D., Green, E., Wolmark, N., Andre, T., Goldberg, R.M., and De Gramont, A. (2005), “Disease-Free Survival Versus Overall Survival As a Primary End Point for Adjuvant Colon Cancer Studies: Individual Patient Data From 20,898 Patients on 18 Randomized Trials,” Journal of Clinical Oncology, 23, 8664–8670.
   PubMed Web of Science ®Google Scholar
• Spiegelhalter, D.J., Abrams, K.R., and Myles, J.P. (2004), Bayesian Approaches to Clinical Trials and Health Care Evaluation, Chichester: Wiley.
   Google Scholar
• Spiegelhalter, D.J., Freedman, L.S., and Parmar, M.K. B. (1993), “Applying Bayesian Ideas in Drug Development and Clinical Trials,” Statistics in Medicine, 12, 1501–1511.
   PubMed Web of Science ®Google Scholar
• Stallard, N., Whitehead, J., and Cleall, S. (2005), “Decision Making in a Phase II Trial. A New Approach Combining Bayesian and Frequentist Concepts.” Pharmaceutical Statistics, 4, 119–128.
   Web of Science ®Google Scholar
• The European Medicines Agency (2011), Special topics: Benefit Risk Methodology. . Available at www.emea.europa.eu.
   Google Scholar
• Tierney, J.F., Stewart, L.A., Ghersi, D., Burdett, S., and Sydes, M.R. (2007), “Practical Methods for Incorporating Summary Time-to-Event Data Into Meta-Analysis,” Trials, 8, 16.
   PubMed Web of Science ®Google Scholar