Publications of Frank Miller
Publications in peerreviewed journals
 Friede T, Posch M, Zohar S, Alberti C, Benda N, Comets E, Day S, Dmitrienko A, Graf A, Günhan BK, Hee SW, Lentz F, Madan J, Miller F, Ondra T, Pearce M, Röver C, Toumazi A, Unkel S, Ursino M, Wassmer G, Stallard N (2018).
Recent advances in methodology for clinical trials in small populations: the InSPiRe project.
Orphanet Journal of Rare Diseases to appear.
 Miller F, Burman CF (2018).
A decision theoretical modeling for Phase III investments and drug licensing.
Journal of Biopharmaceutical Statistics, 28, 698721.
 Miller F, Zohar S, Stallard N, Madan J, Posch M, Hee SW, Pearce M, Vågerö M, Day S (2018).
Approaches to sample size calculation for clinical trials in rare diseases.
Pharmaceutical Statistics, 17, 214230. A prepeer reviewed version is available on the InSPiReproject homepage.
 Pearce M, Hee SW, Madan J, Posch M, Day S, Miller F, Zohar S, Stallard N (2018).
Value of information methods to design a clinical trial in a small population to optimise a health economic utility function.
BMC Medical Research Methodology, 18: 20.
 Posch M, Klinglmueller F, König F, Miller F (2018).
Estimation after blinded sample size reassessment.
Statistical Methods in Medical Research, 27, 18301846.
 Broberg P, Miller F (2017).
Conditional estimation in twostage adaptive designs.
Biometrics, 73, 895904.
The author version of the paper is available on arXiv.
 Hee SW, Willis A, Smith CT, Day S, Miller F, Madan J, Posch M, Zohar S, Stallard N (2017).
Does the low prevalence affect the sample size of interventional clinical trials of rare diseases? An analysis of data from the aggregate analysis of clinicaltrials.gov.
Orphanet Journal of Rare Diseases, 12: 44.
 Stallard N, Miller F, Day S, Hee SW, Madan J, Zohar S, Posch M (2017).
Determination of the optimal size for a clinical trial accounting for the population size.
Biometrical Journal, 59, 609625.
 Hee SW, Hamborg T, Day S, Madan J, Miller F, Posch M, Zohar S, Stallard N (2016).
Decision theoretic designs for small trials and pilot studies: a review.
Statistical Methods in Medical Research, 25, 10221038.
 Ondra T, Dmitrienko A, Friede T, Graf A, Miller F, Stallard N, Posch M (2016).
Methods for identification and confirmation of targeted subgroups in clinical trials: a systematic review.
Journal of Biopharmaceutical Statistics, 26, 99119.
 FackleFornius E, Miller F, Nyquist H (2015).
Implementation of maximin efficient designs in dosefinding studies.
Pharmaceutical Statistics, 14, 6373.
 Karin A, Hannesdottir K, Jaeger J, Annas P, Segerdahl M, Karlsson P, Sjögren N, von Rosen T, Miller F (2014).
Psychometric evaluation of ADASCog and NTB for measuring drug response.
Acta Neurologica Scandinavica, 129, 114122.
 Miller F, Björnsson M, Svensson O, Karlsten R (2014).
Experiences with an adaptive design for a dosefinding study in patients with osteoarthritis.
Contemporary Clinical Trials, 37, 189199.
 Miner PB Jr, Silberg DG, Ruth M, Miller F, Pandolfino J (2014).
Dosedependent effects of lesogaberan on reflux measures in patients with refractory gastroesophageal reflux disease: a randomized, placebocontrolled study.
BMC Gastroenterology, 14: 188.
 Fransson B, Silberg DG, Niazi M, Miller F, Ruth M, Aurell Holmberg A (2012).
Effect of food on the bioavailability of lesogaberan given as an oral solution or as modifiedrelease capsules in healthy male volunteers. International Journal of Clinical Pharmacology and Therapeutics, 50, 307314.
 Friede T, Miller F (2012).
Blinded continuous monitoring
of the nuisance parameter in clinical trials.
J. Royal Stat. Soc. – Series C, 61, 601618.
 Kalliomäki J, Miller F, Kågedal M, Karlsten R (2012).
Early phase drug development for treatment of chronic pain –
new options for clinical trial and program design. Contemporary Clinical Trials, 33, 689699.
 Bischoff W, Miller F (2010).
Doptimally lackoffittestsefficient designs with an application to a fertilizerresponserelationship.
Journal of
Statistics and Applications, 5, 119137.
 Dragalin V, Bornkamp B, Bretz F, Miller F, Padmanabhan SK, Patel N, Perevozskaya I, Pinheiro J, Smith JR (2010).
A simulation study to compare new adaptive doseranging designs. Statistics in Biopharmaceutical Research, 2, 487512.
 Miller F (2010).
Adaptive
dosefinding: Proof of Concept with type I error control. Biometrical
Journal, 52, 577589.
 Niazi M, Silberg DG, Miller F, Ruth M, Aurell Holmberg A (2010).
Evaluation of the Pharmacokinetic Interaction
Between Lesogaberan (AZD3355), a Novel Reflux Inhibitor, and Esomeprazole in Healthy Subjects. Drugs in R&D, 10(4), 243251.
 Peuskens J, Trivedi J, Brecher M, Miller F on behalf of the Study 4 investigators (2010).
Longterm
symptomatic remission of schizophrenia with oncedaily extended release quetiapine fumarate: posthoc analysis of data from
a randomised withdrawal, placebocontrolled study. Int Clin Psychopharmacol. 25(3), 183187.
 Pinheiro J, Sax F, Antonijevic Z, Bornkamp B, Bretz F,
ChuangStein C, Dragalin V, Fardipour P, Gallo P, Gillespie W, Hsu CH, Miller F, Padmanabhan SK, Patel N, Perevozskaya I,
Roy A, Sanil A, Smith JR (2010).
Adaptive and modelbased doseranging trials:
quantitative evaluation and recommendations. Statistics in Biopharmaceutical
Research, 2, 435454. Rejoinder p.466468.
 Bischoff W, Miller F (2009).
A
seamless phase II/III design with samplesize reestimation. Journal of
Biopharmaceutical Statistics, 19,595609.
 Miller F, Friede T, Kieser M (2009).
Blinded
assessment of treatment effects utilizing information about the
randomization block length. Statistics in Medicine, 28, 16901706.
 Newcomer J, Ratner R, Eriksson J, Emsley R, Meulien D, Miller F, LeonovaEdlund J, Leong R, Brecher M (2009).
A 24week, multicenter, openlabel,
randomized study to compare changes in glucose metabolism in patients with schizophrenia receiving treatment with olanzapine,
quetiapine and risperidone.
J Clin Psychiatry 70(4), 487499.
 Möller HJ, Johnson S, Mateva T, Brecher M, Svensson O, Miller F, Meulien D (2008).
Evaluation
of the feasibility of switching from immediate release quetiapine to
extended release quetiapine fumarate in stable outpatients with schizophrenia.
International Clinical Psychopharmacology, 23 (2), 95105.
 Miller F, Guilbaud O, Dette H (2007).
Optimal
designs for estimating the interesting part of a doseeffect
curve. Journal of Biopharmaceutical Statistics, 17,
10971115. Link
to preprint (at RuhrUniversität Bochum).
 Peuskens J, Trivedi J, Malyarov S, Brecher M, Svensson O, Miller F, Persson I, Meulien D
on behalf of the study D1444C00004 investigators (2007).
Prevention of Schizophrenia Relapse with
Extended Release Quetiapine Fumarate Dosed Once Daily: A Randomized, PlaceboControlled Trial in Clinically Stable Patients.
Psychiatry, 4, 3450.
 Bischoff W, Miller F (2006).
Lackoffitefficiently optimal designs
to estimate the highest coefficient of a polynomial with large
degree. Statistics and Probability Letters, 15, 17011704.
 Bischoff W, Miller F (2006).
Optimal designs which are efficient for
lack of fit tests. Annals of
Statistics, 34, 20152025.
 Bischoff W, Miller F. (2006).
Efficient
lack of fit designs that are
optimal to estimate the highest coefficient of a polynomial. Journal of
Statistical Planning and Inference, 136, 42394249.
 Bischoff W, Hashorva E, Hüsler J, Miller F (2005).
Analsis of a
changepoint regression problem in quality control by partial sums processes and
Kolmogorov type tests. Metrika,62, 8598.
 Bischoff W, Miller F (2005).
Adaptive two stage test procedures to
find the best treatment in clinical trials. Biometrika, 92, 197212.
 Miller F (2005).
Variance
estimation in clinical studies with interim sample size
reestimation. Biometrics, 61, 355361.
Link to preprint.
 Bischoff W, Hashorva E, Hüsler J, Miller F (2004).
On
the power of the Kolmogorov test to detect the trend of a Brownian bridge with applications to a
changepoint problem in regression models. Statistics &
Probability Letters, 66, 105115.
 Bischoff W, Hashorva E, Hüsler J, Miller F (2003).
Exact
asymptotics for boundary crossings of the Brownian bridge with trend with
application to the Kolmogorov test. Annals of the Institute of Statistical
Mathematics, 55, 849864.
 Bischoff W, Miller F, Hashorva E, Hüsler J (2003).
Asymptotics of
a boundary crossing probability of a Brownian bridge with general
trend. Methodology and Computing in Applied Probability, 5, 271287.
 Bischoff W, Miller F (2002).
A minimax two stage procedure for
comparing treatments: looking at a hybrid test and estimation problem as a
whole. Statistica Sinica, 12, 11331144.
 Friede T, Miller F, Bischoff W, Kieser M (2001).
A note on change
point estimation in doseresponse trials. Computational
Statistics and Data Analysis, 37, 219232.
 Bischoff W, Miller F (2000).
Asymptotically optimal tests and optimal
designs for testing the mean in regression models with applications to
changepoint problems. Annals of the Institute of Statistical Mathematics,
52, 658679.
 Friede T, Kieser M, Miller F (2000).
Modeling
the Recovery from Depressive Illness by an Exponential Model with Mixed Effects. Methods of
Information in Medicine, 39, 1215.
Book chapters, book review and discussionpaper
 Miller F (2015).
When is an adaptive design useful in clinical dosefinding trials?
In FackleFornius E, editor, Festschrift in Honor of Hans Nyquist on the Occasion of his 65th Birthday. Department of Statistics, Stockholm University.
 Gaydos B, Koch A, Miller F, Posch M, Vandemeulebroecke M, Wang SJ (2012).
Perspective on adaptive designs: 4 years European Medicines Agency reflection paper, 1 year draft US FDA guidance – where are we now?
Clinical Investigation, 2, 235240.
 Burman CF, Miller F, Wong KW (2010).
Improving dosefinding – a philosophic view.
Book chapter in Handbook of Adaptive Designs in Pharmaceutical and Clinical Development by Pong, A., Chow, S.C.
 Miller F, Wiklund SJ (2008).
Book review:
Adaptive design methods in clinical trials. SheinChung Chow and Mark Chang,
Chapman & Hall/CRC, Boca Raton, FL, 2007. Statistics in Medicine, 27, 46114612.
Open access computer program
 Program for adaptive multiple contrast tests and other test considered
in my article "Adaptive dosefinding: Proof of Concept with type I error control." (Biometrical Journal).
Program was peerreviewed. Open access.
Monographs in German (PhD and diploma thesis)
 Miller F (2002).
Optimale
Versuchspläne bei Einschränkungen in der Versuchspunktwahl (Optimal experimental
designs under constraints – in German). PhD thesis. Fakultät für
Mathematik – Universität Karlsruhe.
 Miller F (1997).
ChangepointProbleme im Regressionsmodell und optimale
Versuchsplanung (Changepointproblems in regression models and optimal
experimental design – in German). Diploma thesis. Fakultät für Mathematik
 Universität Karlsruhe.
Citations report
at Google Scholar
