Volume 10.
(as bibtex)
107 references.
Articles

12. Analysis of multiple endpoints in clinical trials: It's time for the designations of primary, secondary and tertiary to go
Snapinn, Steven,
Jiang, Qi

12. Analysis of multiple endpoints in clinical trials: it's time for the designations of primary, secondary and tertiary to go†
Jiang, Qi,
Snapinn, Steven

105114. An alternative phase II/III design for continuous endpoints
Huang, WongShian,
Liu, Jenpei,
Hsiao, ChinFu

115121. The correlation structure of longitudinal measurements of vision in patients with macular degeneration
Burzykowski, Tomasz,
Buyse, M.

122127. A flexible class of models for data arising from a ‘thorough QT/QTc study’
Ghosh, Sujit K.,
Anand, Suraj P.

122127. A flexible class of models for data arising from a 'thorough QT/QTc study'
Anand, Suraj P.,
Ghosh, Sujit K.

128134. Guidelines for accurate EC50/IC50 estimation
Sebaugh, J. L.

135142. The effect of variability and carryover on average bioequivalence assessment: A simulation study
Pilar Sánchez O, Mar\’ıa,
Ocaña, Jordi,
Carrasco, Josep L.

1426. Confirmatory analysis for phase III population pharmacokinetics
Hu, Chuanpu,
Zhang, Ji,
Zhou, Honghui

143149. Fitting $E_max$ models to clinical trial doseresponse data
Kirby, Simon,
Brain, Phil,
Jones, Byron

143149. Fitting Emax models to clinical trial dose–response data
Jones, Byron,
Brain, Phil,
Kirby, Simon

150161. Optimal caliper widths for propensityscore matching when estimating differences in means and difference in proportions in observational studies
Austin, Peter C.

150161. Optimal caliper widths for propensityscore matching when estimating differences in means and differences in proportions in observational studies
Austin, Peter C.

162168. Reference regions for beattobeat ECG data
Crimin, Kimberly S.,
Emerson, John W.,
Muirhead, Robb J.

169174. A method for obtaining randomized block designs in preclinical studies with multiple quantitative blocking variables
Iturria, Stephen J.

175182. A course for clinical trial personnel in clinical study designs, randomization, allocation schedules, and interactive response systems
Golm, Gregory T.,
Bradstreet, Thomas E.,
Coffey, Laura A.

183184. Literature review OctoberDecember 2010
Stone, Andrew,
Zhou, Tianhui

183184. Literature Review October–December 2010
Zhou, Tianhui,
Stone, Andrew

185186. Adaptive design theory and implementation using SAS and R Mark Chang (2007) ISBN 1584889624; 440 pages; £48.99, $89.95 Chapman & Hall/CRC; http://www.crcpress.com
Rosenkranz, Gerd

187189. Erratum: Evaluations of Bayesian and maximum likelihood methods in PK models with belowquantificationlimit data
Roger, James,
Yang, Shuying

191195. Intenttotreat analysis in the presence of offtreatment or missing data
Keene, Oliver N.

196202. Another view on the analysis or cardiovascular morbidity/mortality trials
Rosenkranz, Gerd K.

196202. Another view on the analysis of cardiovascular morbidity/mortality trials†
Rosenkranz, Gerd K.

203212. Estimation of the limit of detection for quantal response bioassays
van den Heuvel, Edwin

213217. On assessing the presence of evaluationtime bias in progressionfree survival in randomized trials
Kay, Richard,
Wu, Jane,
Wittes, Janet

218226. Planning a Bayesian earlyphase phase I/II study for human vaccines in HER2 carcinomas
Gregori, Dario,
Masucci, Giuseppe,
Merletti, Franco,
Forni, Guido,
Baldi, Ileana,
Zohar, Sarah

218226. Planning a Bayesian earlyphase I/II study for human vaccines in HER2 carcinomas
Zohar, Sarah,
Baldi, Ileana,
Forni, Guido,
Merletti, Franco,
Masucci, Giuseppe,
Gregori, Dario

227231. Large sample inference for an assay quality measure used in highthroughput screening
Majumdar, Antara,
Stock, David

232235. Issues for stratified randomization based on a factor derived from a continuous baseline variable
Qu, Yongming

236249. Review of the statistical analysis of the dog telemetry study
Aylott, Mike,
Bate, Simon,
Collins, Susie,
Jarvis, Philip,
Saul, Jim

250256. The role of the minimum clinically important difference and its impact on designing a trial
ChuangStein, Christy,
Kirby, Simon,
Hirsch, Ian,
Atkinson, Gary

257264. Detecting data fabrication in clinical trials from cluster analysis perspective
Wu, Xiaoru,
Carlsson, Martin

265276. Mixed models for data though QT studies: Part 1. assessment of marginal QT prolongation
Schall, Robert,
Ring, Arne

265276. Mixed models for data from thorough QT studies: part 1. assessment of marginal QT prolongation
Ring, Arne,
Schall, Robert

2733. Estimating time to steady state using the effective rate of drug accumulation
Panebianco, Deborah L.,
Maes, Andrea

277279. An MSEreduced estimator for the response proportion in a twostage clinical trial
Li, Qizhai

280281. Literature Review July–September 2010
Zhou, Tianhui,
Stone, Andrew

284288. Estimation of pharmacokinetic parameters with the R package PK
Wolfsegger, Martin J.,
Jaki, Thomas

289292. A ratiotocontrol Williamstype test for trend
Djira, Gemechis D.,
Hothorn, Ludwig A.

293301. Mixed models for data from thorough QT studies: Part 2. Onestep assessment of conditional QT prolongation
Schall, Robert

37. Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies
ChuangStein, Christy,
Beltangady, Mohan

302310. Evaluating surrogate variables for improving microarray multiple testing inference
Mehrotra, Devan V.,
Hu, Peter H.,
Chen, Guang,
Lunceford, Jared K.

311317. The perils with the misuse of predictive power
Fina, Paolo,
Dallow, Nigel

318324. Testing noninferiority and superiority for two endpoints for several treatments with a control
Lawrence, John

325331. Sample size reestimation for survival data in clinical trials with an adaptive design
Iwasaki, Manabu,
Togo, Kanae

332340. Assessing noninferiority to an aggregate response with an application to development of pneumococcal conjugate vaccines
Dallas, Michael J.,
Liu, Guanghan F.,
Pan, Yi

3439. Potential surrogate endpoints in cancer research Some considerations and examples
Duffy, S. W.,
Treasure, F. P.

3439. Potential surrogate endpoints in cancer research – some considerations and examples
Treasure, F. P.,
Duffy, S. W.

341346. Block responseadaptive randomization in clinical trials with binary endpoints
Magirr, Dominic

347356. An adaptive seamless phase II/III design for oncology trials with subpopulation selection using correlated survival endpoints†
Jennison, Christopher,
Stone, Andrew,
Jenkins, Martin

357362. Assessing departure from dose linearity under a repeated measures incomplete block design
Chow, SheinChung,
Cheng, Bin

363368. A guide to the design and analysis of small clinical studies
Islam, M. Zahur,
Kianifard, Farid

369373. A flexible multistage design for phase II oncology trials
Xiong, Xiaoping,
Tan, Ming T.

374378. A note on dealing with missing standard errors in metaanalyses of continuous outcome measures in WinBUGS
Stevens, John W.

379380. Literature Review January–March 2011
Zhou, Tianhui,
Stone, Andrew

384392. Review of JMP genomics
Lovell, David P.

4044. Graphical displays for clarifying how allocation ratio affects total sample size for the two sample logrank test
Saville, Benjamin R.,
Kim, Yong S.,
Koch, Gary G.

4549. The impact of period effects on dose level contrasts in alternating crossover designs for firsttimeinhuman studies
KoehneVoss, Stephan,
Schmidli, Heinz,
Smith, David M.,
Pigeot, Iris

5059. Effects of unstratified and centrestratified randomization in multicentre clinical trials
Anisimov, Vladimir V.

6069. Making available information from studies sponsored by the pharmaceutical industry: Some current practices
O'Kelly, Michael,
Julious, Steven A.,
Pyke, Stephen,
Day, Simon,
Todd, Sue,
Seldrup, Jorgen,
Matcham, James

7073. Proposed best practice for statisticians in the reporting an publication of pharmaceutical industrysponsored clinical trials
Matcham, James,
Julious, Steven,
Pyke, Stephen,
O'Kelly, Michael,
Todd, Susan,
Seldrup, Jorgen,
Day, Simon

7073. Proposed best practice for statisticians in the reporting and publication of pharmaceutical industrysponsored clinical trials
Day, Simon,
Seldrup, Jorgen,
Todd, Susan,
O'Kelly, Michael,
Pyke, Stephen,
Julious, Steven,
Matcham, James

7479. The potential for bias in reporting of industrysponsored clinical trials
Pyke, Stephen,
Julious, Steven A.,
Day, Simon,
O'Kelly, Michael,
Todd, Susan,
Matcham, James,
Seldrup, Jorgen

813. Blinded sample size recalculation for clinical trials with normal data and baseline adjusted analysis
Friede, Tim,
Kieser, Meinhard

8081. Comments on ‘The potential for bias in the reporting of industry sponsored clinical trials’ by Stephen Pyke et al. and ‘Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry sponsored clinical trials’ by James Matcham et al. Pharmaceutical Statistics
Campbell, M. J.

8081. Comment on ''The potential for bias in the reporting of industry sponsored clinical trials'' (2010V10 p7479) and comment on ''proposed best practice for statisticians in the reporting and publication of pharmaceutical industry sponsored clinical trials''' (2010V10, p7073)
Campbell, M. J.

8284. Professional responsibilities
Jacobs, Adam

8788. Statistical resource needs the be increased in the European regulatory agencies
Keene, Oliver N.,
Hughes, Sara H.,
Howitt, Nigel

8788. Statistical resource needs to be increased in the European regulatory agencies
Directors, on behalf of the PSI and EFSPI Boards of,
Howitt, Nigel,
Hughes, Sara H.,
Keene, Oliver N.

8995. Adapting by calibration the sample size of a phase III trial on the basis of phase II data
Martini, Daniele De

8995. Adapting by calibrating the sample size of a phase III trial in the basis of phase II data
De Martini, Daniele

96104. Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim
Posch, Martin,
Mauer, Willi,
Bretz, Frank

. Issues in the assessment of noninferiority: perspectives drawn from case studies
Abt, Markus,
Beyer, Ulrich,
Burger, H. Ulrich

. Designing a noninferiority study in kidney transplantation: a case study†
Racine, Amy,
O'Hagan, Anthony,
Schmidli, Heinz,
Witte, Steffen

. Indirect comparisons in the comparative efficacy and noninferiority settings
Jiang, Qi,
Snapinn, Steven

. The draft FDA guideline on noninferiority clinical trials: a critical review from European pharmaceutical industry statisticians
(EFSPI), on behalf of European Federation of Statisticians in the Pharmaceutical Industry,
Hummel, Jürgen,
Huitfeldt, Bernhard

. Determining the noninferiority margin for patient reported outcomes
Schmelter, Thomas,
Gerlinger, Christoph

. 10 Years with ICH E10: Choice of Control Groups
Enas, Gregory G.,
Rockhold, Frank W.

. Modeling data with structural and temporal correlation using lower level and higher level multilevel models†
Miller, Sam,
Zhou, Yinghui,
James, Gareth

. Time to end the noninferiority complex?
Julious, Steven A.

. Why a Bayesian approach to safety analysis in pharmacovigilance is important
Kim, Joseph,
Wang, Jixian,
Quartey, George,
PrietoMerino, David

. Opportunities for minimization of confounding in observational research
Kim, Joseph,
Wang, Jixian,
FeudjoTepie, Maurille,
Quartey, George

. Subgroup analyses of clinical effectiveness to support health technology assessments
Reid, Carol,
Fletcher, Christine,
ChuangStein, Christy,
Paget, MarieAnge

. Statistical approaches for conducting network metaanalysis in drug development
subteam, on behalf of PSI Health Technology Special Interest Group Evidence Synthesis,
Moneuse, Patrick,
Tate, Helen,
Cappelleri, Joseph C.,
Fletcher, Chrissie,
Lawton, Andy,
Lane, Peter W.,
Roger, James,
Jones, Byron

. Predictive event modelling in multicenter clinical trials with waiting time to response
Anisimov, Vladimir V.

. Modelling and simulation in the pharmaceutical industry—some reflections
Wiklund, Stig Johan,
Burman, CarlFredrik

. A statistician's perspective on biomarkers in drug development
Group, on behalf of the PSI Biomarker Special Interest,
Matcham, James,
Jarvis, Philip,
Herath, Athula,
Delmar, Paul,
Ratnayake, Jayantha,
Sabin, Tony,
Harbron, Chris,
Smart, Trevor,
Flynn, Aiden,
Jenkins, Martin

. Recommendations on the statistical analysis of the Comet assay
Vonk, Richardus,
Saul, Jim,
Jarvis, Philip,
Geys, Helena,
Bate, Simon,
Aylott, Mike,
Bright, Jonathan

. An assessment of the statistical methods used to analyse toxicology studies
Sherington, John,
Geys, Helena,
Bate, Simon,
Aylott, Mike,
Saul, Jim,
Jarvis, Philip

. Six sigma in the pharmaceutical industry Brian K Nunnally, and John S McConnell (2007) ISBN: 1420054392; 224 pages; £59.99, €48.90, $93.95 Chapman & Hall/CRC; http://www.crcpress.com
Porter, Max

. Validating clinical trial data reporting with SAS, Matthews CI, Shilling BC (2008) ISBN: 9781599941288; 228 pages; $36.95, £52.05 SAS Institute Inc.;http://www.sas.com/
Weir, Christopher J.

. Statistical thinking for nonstatisticians in drug regulation Richard Kay (2007) ISBN 0470319712; 296 pages; £39.95, €52.90, $80.00 Wiley; http://www.wiley.com/
Mitchell, Lada

. Bayesian biostatistics and diagnostic medicine broemeling Lyle D (2007) ISBN 1584887672; 216 pages; £42.99, $83.95 Chapman & Hall/CRC; http://www.crcpress.com/
Yang, Shuying

. PSI's Pharmaceutical Statistics Journal Club
Harris, Julia,
Cleverly, Ann,
Maudsley, Rhiannon

. Commentary: Professional responsibilities
Jacobs, Adam

. Handbook of regression and modeling: applications for the clinical and pharmaceutical industries Paulson DS (2007) ISBN 157444610X; 520 pages; £57.99, $104.95 Chapman & Hall/CRC; http://www.crcpress.com/
Rosenblad, Andreas

. A review of risk measures in pharmacoepidemiology with tips for statisticians in the pharmaceutical industry
Kim, Joseph,
Wang, Jixian,
Quartey, George

. Pharmaceutical Statistics 10th anniversary
Stevens, John W.,
Hutchinson, Katherine

. Pharmaceutical Statistics Using SAS®: A Practical Guide Alex Dmitrienko, Christy ChuangStein, Ralph D'Agostino ISBN: 9781590478868, 444 pages; $69.95, £98.54; SAS Institute Inc; www.sas.com
Liu, Feng,
Li, Gang

. Introduction to statistical methods for clinical trials, Thomas D Cook, David L DeMets ISBN: 9781584880271; 439 pages; $73.95Chapman and Hall/CRC
Ebbutt, Alan

. Bayesian Computation with R, Jim Albert (2008) ISBN 0387713840; 270 pages; $49.95 Springer; http://www.Springer.com/
Southworth, Harry

. DNA methylation microarrays: Experimental design and statistical analysis, SunChong Wang, Arturas Petronis (2008) ISBN: 1420067273; 256 pages; £49.99, $79.95 Chapman & Hall/CRC;http://www.crcpress.com/
Bujac, Sarah

. Data and safety monitoring committees in clinical trials, Herson J (2009) ISBN: 9781420070378; 173 pages + xviii; £54.99, $89.95 Chapman and Hall/CRC;http://www.crcpress.com
Day, Simon

. Adjusting for covariates in noninferiority studies with margins defined as risk differences†
Cuffe, Robert L.,
Embleton, Andrew,
Mohamed, Khadeeja

. Active controlled studies in antibiotic drug development
Dane, Aaron

. The ABC of noninferiority margin setting from indirect comparisons
Julious, Steven A.

. An evidential approach to noninferiority clinical trials†
Blume, Jeffrey D.,
Wang, SueJane