Latest Publications
- Dalgleish AG et al. Randomised, open label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer. British Journal of Cancer (2016) 1-8.
- E Burmeister Getz, KJ Carroll, B Jones, LZ Benet, Batch-to-Batch Pharmacokinetic Variability Confounds Current Bioequivalence Regulations: A Dry Powder Inhaler Randomized Clinical Trial, Clinical Pharmacology & Therapeutics, Volume 100, Number 3, Sept 2016
Survival Analysis and Oncology Trial Design
- Carroll KJ. On the use and utility of the Weibull model in the analysis of survival data. 2003, Controlled Clinical Trials 24: 682–701
- Klotz L, Schellhammer P, Carroll K. A re-assessment of the role of combined androgen blockade for advanced prostate cancer. BJU Int. 2004; 93(9):1177-82.
- Ellis S, Carroll KJ and Pemberton K. Analysis of Duration of Response in Oncology Trials. Contemporary Clinical Trials, 2008; 29: 456–465
Surrogate Endpoints and Assessment
- Newling D, Carroll K and Morris T. Is prostate-specific antigen progression a surrogate for objective clinical progression in early prostate cancer? 2004, Journal of Clinical Oncology, ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 4652
- Collette L, Burzykowski T, Carroll KJ et al. Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint Research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals. 2005, Journal of Clinical Oncology; 23:6139–6148.
- Buyse M, Burzykowski T, Carroll K et al. Progression-Free Survival Is a Surrogate for Survival in Advanced Colorectal Cancer. J Clin Oncol, 2007; 25:5218-5224.
Progression Free-Survival in Oncology Trials
- Carroll KJ. Analysis of progression-free survival in oncology trials: some common statistical issues. Pharmaceutical Statistics, 2007; Vol 6(2): 99-113
- Stone A, Wheeler C, Carroll K and Barge A. Optimizing randomized phase II trials assessing tumor progression. Contemporary Clinical Trials, 2007; 28(2):146-52
Biomarkers in Trial Design
- Carroll KJ. Biomarkers in drug development: friend or foe? A personal reflection gained working within oncology. Pharmaceutical Statistics, 2007; 6(4): 253–260
Conditional Approval in the EU
- Carroll K, Chaudri Ross H, Evans D et al. Conditional approval: discussion points from the PSI conditional approval expert group. Pharmaceutical Statistics, 2008; 7: 263–269
Cardiovascular Outcomes Trial Design
- Carroll KJ. Back to basics: explaining sample size in outcome trials, are statisticians doing a thorough job? Pharmaceutical Statistics, 2009; 8: 333–345.
Non-Inferiority Trial Design and Analysis
- Carroll K and Milsted R. Barriers to clinical development in oncology: The impact of new thinking around non-inferiority. 2004, Journal of Clinical Oncology, ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 6082.
- Carroll K, Milsted B and Lewis JA. Design and analysis of non-inferiority mortality trials in oncology. Letter to the Editor. Statistics in Medicine 2004, Vol 23(17): 2771-2774
- Carroll K, Milsted B and Lewis JA. Design and analysis of non-inferiority mortality trials in oncology. Letter to the Editor. Statistics in Medicine 2004, Vol 23(17): 2771-2774
- Carroll KJ. Active-controlled, non-inferiority trials in oncology: arbitrary limits, infeasible sample sizes and uninformative data analysis. Is there another way? Pharmaceutical Statistics, 2006; Vol 5(4): 283-293.
- Peterson P, Carroll K, Chuang-Stein C, Ho Y-Y, Jiang Q, Li Gang, Sanchez M, Sax R, Wang Y-C, Snapinn S. PISC Expert Team White Paper: Toward a Consistent Standard of Evidence When Evaluating the Efficacy of an Experimental Treatment From a Randomized, Active-Controlled Trial. Statistics in Biopharmaceutical Research 2010; 2(4): 522-531.
- Carroll KJ. Statistical issues and controversies in active-controlled, ‘non-inferiority’ trials. 2013 Statistics in Biopharmaceutical Research Vol 5(3): 229-238.
Multi Regional Trial Design and Analysis
- Inker et al Tufts Early Change in Urine Protein as a Surrogate End Point in Studies of IgA Nephropathy: An Individual-Patient Meta-analysis, Am J Kidney Dis. 2016
- Carroll, KJ and Le Maulf, F. Japanese Guideline on Global Clinical Trials: Statistical Implications and Alternative Criteria for Assessing Consistency. DIJ, 2011; 45: 657-667.
- Mahaffey, KW, Wojdyla DM, Carroll K et al. Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2011 Aug 2; 124(5):544-54.
- Carroll KJ and Fleming TR. Statistical evaluation and analysis of regional interactions: The PLATO trial case study. 2013 Statistics in Biopharmaceutical Research Vol 5(2): 91-101.
Decision Making in Drug Development
- Carroll KJ. Decision Making from Phase II to Phase III and the Probability of Success: Reassured by ‘Assurance’? 2013 Journal of Biopharmaceutical Statistics Vol 23(5): 1188-1200.
- Carroll KJ and Hemmings R. On the need for increased rigour and care in the conduct and interpretation of network meta-analyses in drug development. Pharm Stat. 2016; 15(2):135-42