International Symposium on Adaptive Clinical Trial Designs

Gallo P Chuang-Stein C Dragalin V Adaptive designs in clinical drug development—an executive summary of the PhRMA Working Group. J Biopharm Stat. 2006; 16:275–283.

Dragalin V . Adaptive designs: terminology and classification. Drug Inf J. 2006; 40(4):421–484.

For more information, see www.fda.gov/oc/initiatives/criticalpath/ and www.fda.gov/oc/speeches/trialdesign0710.html.

The Innovative Medicines Initiative (IMI): Strategic Research Agenda Creating Biomedical R&D Leadership for Europe to Benefit Patients and Society. Available at http://www.efpia.org/4_pos/SRA.pdf. Accessed October 10, 2006.

Committee for Medicinal Products for Human Use (CHMP). Draft reflection paper on methodological issues in confirmatory clinical trials with flexible design and analysis plan. London, March 23, 2006; Doc. Ref. CHMP/EWP/2459/02. Available at: http://www.emea.europa.eu/pdfs/human/ewp/245902en.pdf. Accessed October 10, 2006.

Gluud C . The culture of designing hepatobiliary trials. J Hepatol. 2006; 44:607–615.

Gluud LL . Bias in clinical intervention research. Am J Epidemiol. 2006; 163:493–501.

Higgins JPT Green S , eds. Cochrane Handbook for Systematic Reviews of Interventions 4.2.6 [updated September 2006]. Available at: http://www.cochrane.org/resources/handbook/hbook.htm. Accessed March 26, 2006.

World Health Organization. Research for health: a position paper on WHO's role and responsibilities in health research. ACHR45/05.16 Rev.1; 2006:1–28. Available at http://www.who.int/rpc/meetings/position_paper.pdf. Accessed November 7, 2006.

Young C Horton R . Putting clinical trials into context. Lancet. 2005; 366:107–108.

Wetterslev J. Thorlund K Brok J Gluud C . Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol. In press.

Wetterslev J Thorlund K Brok J Gluud C . Trial sequential analyses of six Cochrane Neonatal Review Group meta-analyses using actual information size. Clin Trials. 2005; 2(Suppl 1):32–33.

Brok J . Thorlund K, Gluud C, Wetterslev J. Trial sequential analyses of six Cochrane Neonatal Review Group meta-analyses considering adequacy of al location concealment. Clin Trials. 2005; 2(Suppl 1):61–62.

Thorlund K Wetterslev J . Brok J, Gluud C. Trial sequential analyses of six Cochrane Neonatal Review Group meta-analyses considering heterogeneity and trial weight. Clin Trials. 2005; 2(Suppl 1):62.

Thorlund K Wetterslev J Brok J Gluud C . Heterogeneity sample size correction factor for meta-analyses. Poster 141 Abstract. XIII. Cochrane Colloq. 2005:146.

Brok J Thorlund K Wetterslev J Gluud C . Trial sequential analyses of positive Cochrane neonatal meta-analyses considering adequacy of allocation concealment. Clin Trials. 2006; 3:241.