The Impact of Incorporating Clinical Relevance on the Feasibility of Clinical Trials Dieter HouschkeDietrich Häfner OriginalPaper 30 December 2008 Pages: 99 - 106
Sample Size Requirements for Clinical Trials with Repeated Binary Outcomes Chul Ahn OriginalPaper 30 December 2008 Pages: 107 - 113
Exact Tests for Epidemiological Risks under Independent Negative Binomial Sampling for Rare Events in Clinical Trials Seung-Ho Kang OriginalPaper 30 December 2008 Pages: 115 - 121
Getting Better Clinical Trial Data: An Inverted Viewpoint Rita Hattemer-ApostelStefanie FischerHorst Nowak OriginalPaper 30 December 2008 Pages: 123 - 130
“Substantial Evidence” from a Replicated Secondary Analysis, Followed by a Single Prospective Confirmatory Study Jonathan DenneGregory Enas OriginalPaper 30 December 2008 Pages: 131 - 138
An Approach to Rationalize Partitioning Sample Size into Individual Regions in a Multiregional Trial Norisuke KawaiChristy Chuang-SteinYoichi Li OriginalPaper 30 December 2008 Pages: 139 - 147
Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations Robert I. Roth OriginalPaper 30 December 2008 Pages: 149 - 159
Pharmaceutical and Analytical Quality Control Services: Ownership or Outsourcing—A South African Case Study Henry M. J. LengMalebona P. Matsoso OriginalPaper 30 December 2008 Pages: 161 - 173
Metrics Implementation in an Industry-Based Medical Information Department and Comparison to Metrics Tracked within Other Industry-Based Medical Information Departments Stacey C. SoaresChristi Marsh OriginalPaper 30 December 2008 Pages: 175 - 182
Mega Mergers: A Systematic Approach to the Integration of Two Medical Information Departments Andrew GazoChristine WybleLesley Fierro OriginalPaper 30 December 2008 Pages: 183 - 191
Monitoring Clinical Trial Data Using an Unblinded Industry Statistician Geraldine E. BaggsAnand SethSusan M. Toth OriginalPaper 30 December 2008 Pages: 193 - 199
