The major goals of this project are to investigate and develop statistical models and procedures related to the early detection chronic diseases. The research is motivated from current problems in the early detection of cancer --- especially breast cancer. The research is divided into three major areas: (i) planning clinical trials to evaluate the benefits of early detection of disease; (ii) estimation of parameters (sensitivities, pre-clinical sojourn time distributions) during the course of a trial as well as after the last scheduled examination; and (iii) develop and extend quantitative methods to aid public health planners in the planning of early detection programs to benefit larger populations. The major issues in planning large public health programs for the early detection of disease are: at which ages should individuals begin to participate, the time between examinations and the number of examinations. Methods will be developed for evaluating any proposed public health program. The economic and health implications of applying these models are potentially large. The major issues in planning early detection clinical trials are to take advantage of the special features of these trials; e.g., number of exams, spacing between exams, the changing incidence of disease with age, and the history of each subject with regard to earlier exams. Experimental design problems arise as in some disease area control groups (no exams) may not be feasible. The major issues in parameter estimation relate to having more than one detection modality, possibly resulting in different pre-clinical sojourn time distributions, ascertaining if sensitivity and sojourn time distributions are age dependent, compliance, and investigating if different detection modalities are independent.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA078607-01
Application #
2681266
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Program Officer
Nayfield, Susan G
Project Start
1998-08-01
Project End
2001-07-31
Budget Start
1998-08-01
Budget End
1999-07-31
Support Year
1
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Dana-Farber Cancer Institute
Department
Type
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
02215
Lee, Sandra J; Zelen, Marvin (2008) Mortality modeling of early detection programs. Biometrics 64:386-95
Davidov, Ori; Zelen, Marvin (2003) The theory of case-control studies for early detection programs. Biostatistics 4:411-21
Lee, S J; Zelen, M (2003) Modelling the early detection of breast cancer. Ann Oncol 14:1199-202
Parmigiani, Giovanni; Skates, Steven; Zelen, Marvin (2002) Modeling and optimization in early detection programs with a single exam. Biometrics 58:30-6
Shen, Y; Wu, D; Zelen, M (2001) Testing the independence of two diagnostic tests. Biometrics 57:1009-17
Shen, Y; Zelen, M (2001) Screening sensitivity and sojourn time from breast cancer early detection clinical trials: mammograms and physical examinations. J Clin Oncol 19:3490-9