Affiliation: National Institutes of Health
- Analysis of progression-free survival data using a discrete time survival model that incorporates measurements with and without diagnostic errorSally Hunsberger
National Cancer Institute, Biostatistics Research Branch, Rockville, MD, USA
Clin Trials 7:634-42. 2010..The second method is considered to be the reference standard but is expensive, time consuming, and logistically difficult. The first method has measurement error associated with it, but, it is less expensive and easier to obtain...
- A comparison of phase II study strategiesSally Hunsberger
Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland 20892, USA
Clin Cancer Res 15:5950-5. 2009..In this article, we compare different phase II study strategies to determine the most efficient drug development path in terms of number of patients and length of time to conclusion of drug efficacy on overall survival...
- Dose escalation trial designs based on a molecularly targeted endpointSally Hunsberger
Biometrics Research Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Stat Med 24:2171-81. 2005..A limited simulation study is performed and the designs are compared with respect to the dose level at the end of escalation and the number of patients treated on study...
- A finite mixture survival model to characterize risk groups of neuroblastomaSally Hunsberger
Biometric Research Branch, National Cancer Institute, 6130 Executive Boulevard, Rm 8120, Rockville, MD 20852, USA
Stat Med 28:1301-14. 2009..The robustness of the model and the prediction method is examined via simulation by looking at misclassification rates under misspecified models...
- Testing logistic regression coefficients with clustered data and few positive outcomesSally Hunsberger
Biometric Research Branch, National Cancer Institute, Bethesda, MD 20892, U S A
Stat Med 27:1305-24. 2008..The proposed method is also useful when testing goodness-of-fit of logistic regression models using deciles-of-risk tables...
- Design issues of randomized phase II trials and a proposal for phase II screening trialsLawrence V Rubinstein
Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA
J Clin Oncol 23:7199-206. 2005....
- Proposal for the use of progression-free survival in unblinded randomized trialsBoris Freidlin
Biometric Research Branch and the Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
J Clin Oncol 25:2122-6. 2007..This proposal, possibly combined with central review of progression scans for these two time points, essentially eliminates any bias, with little risk of major efficiency loss compared with using the reported progression times...
- Physical activity, weight control, and breast cancer risk and survival: clinical trial rationale and design considerationsRachel Ballard-Barbash
Applied Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, EPN 4005, Executive Blvd, Bethesda, MD 20892 7344, USA
J Natl Cancer Inst 101:630-43. 2009....
- Current academic clinical trials in ovarian cancer: Gynecologic Cancer Intergroup and US National Cancer Institute Clinical Trials Planning Meeting, May 2009Edward L Trimble
National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 7436, USA
Int J Gynecol Cancer 20:1290-8. 2010..To review the current status of large phase academic clinical trials for women with ovarian cancer, address cross-cutting issues, and identify promising areas for future collaboration...
- Practical midcourse sample size modification in clinical trialsMichael A Proschan
National Heart, Lung, and Blood Institute, Bethesda, MD, USA
Control Clin Trials 24:4-15. 2003..We show how to compute the p value and confidence interval for this two-stage procedure. If the original sample size is maintained, analysis of the data is the same as for a fixed sample procedure...
- On analyzing circadian rhythms data using nonlinear mixed models with harmonic termsPaul S Albert
Biometric Research Branch, National Cancer Institute, Executive Plaza North, Bethesda, Maryland 20892 7434, USA
Biometrics 61:1115-20; discussion 1120-2. 2005..The proposed parametric approach provides an alternative to Wang et al.'s semiparametric approach and has the added advantage of being easy to implement in most statistical software packages...
- Effective incorporation of biomarkers into phase II trialsLisa M McShane
Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA
Clin Cancer Res 15:1898-905. 2009..A rational and coordinated approach to the inclusion of biomarker studies throughout the drug development process will be the key to attaining the goal of personalized medicine...
- Preliminary data release for randomized clinical trials of noninferiority: a new proposalEdward L Korn
Biometric Research Branch and Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, EPN 8128, National Cancer Institute, Bethesda, MD 20892, USA
J Clin Oncol 23:5831-6. 2005..Examples are given demonstrating how the proposal would work, along with a discussion of possible objections to the proposal...
- Very high-dose methotrexate (33.6 g/m(2)) as central nervous system preventive therapy for childhood acute lymphoblastic leukemia: results of National Cancer Institute/Children's Cancer Group trials CCG-191P, CCG-134P and CCG-144PPaul C Nathan
Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA
Leuk Lymphoma 47:2488-504. 2006..VHD-MTX achieved similar survival to other CNS-directed therapies without the long-term impact on intelligence, but with substantial acute toxicities...
- Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP systemClifford A Hudis
Breast Cancer Medicine Service, Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA
J Clin Oncol 25:2127-32. 2007....
- Innovative designs in behavioural trialsBruce Thompson
Clinical Trials and Surveys Corporation, Suite 350, Village of Cross Keys, Baltimore, Maryland 21210, USA
Stat Med 21:2981-9. 2002..In this paper we use the design of the Raynaud's Treatment Study to demonstrate methods that can be used to control for non-specific effects and differential drop-out from the study...
- The effect of digoxin on the quality of life in patients with heart failureEllis Lader
New York University School of Medicine, New York, New York, USA
J Card Fail 9:4-12. 2003..A prespecified substudy evaluated the effect of digoxin therapy on health-related quality of life (HQOL) in a subset of these patients...