This project continues the development of clinical trial design and statistical analysis methodology for psychopharmacological and other treatments used in the care of the mentally ill.
The specific aims are to: (1) develop design and statistical analysis strategies for dose-response and bioassay studies to characterize a test treatment relative to a standard treatment. Based on models that include patients who are unresponsive at any dose, who respond at any dose or who respond depending on whether their dose is adequate, we will develop methods to analyze """"""""doctor's choice"""""""" study designs. Recursive partitioning approaches for identifying variables that share a common relative potency will be studied. (2) develop clinical trial designs and methods of analysis resulting in clinically informative measures. We will develop an inference framework for optimal scaling techniques for the general linear model and for two-way tables when the data arise from ordered categories. We will develop efficient designs and nonparametric and parametric models and estimators of parameters that are clinically informative. (3) develop simple designs and statistical methods for testing whether each component of a combination therapy contributes to its effect and whether the combination is antagonistic, additive or synergistic. In the multivariate combination problem, we will study new hypothesis formulations that further characterize the requirement that each component """"""""contributes"""""""" to the combination's effects. Alternatives that are more demanding than admissible but less demanding than uniformly best will be developed. We will study the problem of finding a simple experimental design to test for dose additivity, synergy or antagonism when there are two or more doses of the combination, single and multiple endpoints and combinations with two or more drugs. (4) develop robust and optimal crossover and response adaptive clinical trial designs for estimation of treatment and carryover effects. We shall seek optimal crossover designs for an arbitrary number of treatments and periods when there are carryover effects. We will develop response adaptive designs to allocate treatments to patients so as to increase power for hypotheses testing situations involving a min statistic and in the optimal crossover design problem.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH042959-09
Application #
2415910
Study Section
Special Emphasis Panel (SRCM)
Project Start
1988-08-01
Project End
1999-04-30
Budget Start
1997-05-01
Budget End
1998-04-30
Support Year
9
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Nathan Kline Institute for Psychiatric Research
Department
Type
DUNS #
167204762
City
Orangeburg
State
NY
Country
United States
Zip Code
10962
Laska, E M; Meisner, M; Siegel, C et al. (2001) Statistical cost-effectiveness analysis of two treatments based on net health benefits. Stat Med 20:1279-302
Laska, E M; Meisner, M; Siegel, C (1999) Power and sample size in cost-effectiveness analysis. Med Decis Making 19:339-43
Laska, E M; Meisner, M; Siegel, C et al. (1999) Ratio-based and net benefit-based approaches to health care resource allocation: proofs of optimality and equivalence. Health Econ 8:171-4
Laska, E M; Meisner, M; Siegel, C (1997) Statistical inference for cost-effectiveness ratios. Health Econ 6:229-42
Laska, E M; Meisner, M; Siegel, C (1997) The usefulness of average cost-effective ratios. Health Econ 6:497-504
Laska, E M; Meisner, M; Tang, D I (1997) Classification of the effectiveness of combination treatments. Stat Med 16:2211-28
Czobor, P; Volavka, J (1996) Dimensions of the Brief Psychiatric Rating Scale: an examination of stability during haloperidol treatment. Compr Psychiatry 37:205-15
Siegel, C; Laska, E; Meisner, M (1996) Statistical methods for cost-effectiveness analyses. Control Clin Trials 17:387-406
Wolkin, A; Sanfilipo, M; Duncan, E et al. (1996) Blunted change in cerebral glucose utilization after haloperidol treatment in schizophrenic patients with prominent negative symptoms. Am J Psychiatry 153:346-54
Czobor, P; Volavka, J (1996) Positive and negative symptoms: is their change related? Schizophr Bull 22:577-90

Showing the most recent 10 out of 23 publications