Costs of Clinical Trials Study

The Cost of Cancer Trials Study (CCTS) is a study of cancer patients throughout the U.S. being conducted by RAND, a private, non-profit research institution based in Santa Monica, California, with principal funding and scientific guidance from the National Cancer Institute. This study will estimate the incremental costs of medical treatment provided as part of NCI- sponsored protocols. Incremental costs refers to the costs of additional medical resources, if any, provided to patients on protocols above and beyond those that would have been received in the absence of trial participation. The results from this study should be of interest to policymakers, insurers and healthcare decision makers trying to determine appropriate reimbursement for clinical trials. As secondary endpoints, patient satisfaction and health outcomes of patients in trials will be compared with those not in trials. The study will use a multi-stage study design to select 1,600 patients at 50-60 study sites among all of the institutions, clinics or practices in the U.S. that are participating in NCI-sponsored Phase II or III clinical trials. The patient sample will be obtained by randomly selecting patients who have enrolled in a clinical trial during a specified period of time at these study sites. Using cancer registries and chart reviews, a matched control group of cancer patients who did not enroll in a clinical trial will be sampled and followed. Using economic models of costs, the two groups will be compared to estimate the cost of trial participation.

AGENCY SPONSOR: National Cancer Institute


PIC ID: 7116

PERFORMER: Rand Corporation
Santa Monica, CA


Planning and Development of the Early Childhood Longitudinal Study--Year 2000 Birth Cohort

The Early Childhood Longitudinal Study, Year 2000 Birth Cohort (ECLS-B) is sponsored by the U.S. Department of Education, National Center for Education Statistics, in collaboration with the National Center for Health Statistics, the National Institutes of Health, the Administration on Children, Youth & Families, the Department of Agriculture, and other Federal agencies. It is designed to provide detailed information about children's early life experiences, including children's health, development and care, and education from birth through first grade. Beginning in September 2000, over 12,000 nine- month-olds nationwide will be recruited into the ECLS-B. At this time, parents will be interviewed and infants will be observed to learn about their health and development. The study will follow the children and their families for at least six years, by which time most of the children will have reached first grade. Evaluation funds will help shape the ECLS-B into an important health planning, evaluation and research tool. Specifically, the funds will be used to supplement questions and assessments, including costs associated with question development, assessment of data collection methodologies, and field testing. Funds have been committed to support an oversample of twins, an oversample of very low birth weight (VLBW) infants, a self-administered questionnaire for resident fathers, and a self-administered pilot questionnaire for non-resident fathers who have some contact with the child. Data from the ECLS-B are expected to inform many government analyses and policy reviews, including program evaluation and research efforts to focus on infants, and variables that mediate the impact of service or intervention programs, or otherwise influence children's health in this country.

AGENCY SPONSOR: National Institute of Child Health and Human Development

FEDERAL CONTACT: Li, Rose Maria, Ph.D.

PIC ID: 7115

PERFORMER: Department of Education, National Center for Educ Statistics
Washington, DC


Planning Phase for an Evaluation of the NIDR Center Program

This project developed a study design for an evaluation of the National Institute of Dental Research (NIDR) center program.

AGENCY SPONSOR: National Institute of Dental and Craniofacial Research

FEDERAL CONTACT: Corrigan, Dr. James G.

PIC ID: 5578

PERFORMER: National Institute of Dental Research
Bethesda, MD


Population Centers Program Evaluation

For over three decades, the Demographic and Behavioral Sciences Branch (DBSB) has supported the Population Centers Program (PCP), which has provided infrastructure support for population research. Currently, 12 centers are supported nationwide. While the PCP has been critical in supporting the development of population research over these 30 years, it is clear that the needs and institutional context of the discipline have changed significantly over time. In response, the DBSB is evaluating how the PCP is meeting the needs of population researchers today, and whether there are different ways of structuring and competing the program to better serve the future of the science. The DBSB is recruiting a group of five eminent scientists to serve as consultants, and prepare background and summary papers, as well as recommendations, to assist the Branch in conducting the evaluation. Using a variety of data, these scientists will perform a needs assessment, evaluate the current status of the PCP, and prepare papers that summarize their findings and suggestions for modifying the program. The DBSB will convene two or three meetings over the course of a year to monitor progress and assess the need for additional data. The DBSB will also design a procedure for inviting public comment from those who want to express their views on the Center's program, and these comments will be shared with the consultants. Based on the recommendations made by individual consultants, and discussions at meetings of the consultants and other scientists, the DBSB will work with Institute staff to translate the suggestions into appropriate NICHD mechanisms and policies.

AGENCY SPONSOR: National Institute of Child Health and Human Development

FEDERAL CONTACT: Bachrach, Christine A., Ph.D.

PIC ID: 7119

PERFORMER: National Institute of Child Health and Human Development
Bethesda, MD


Surgeon General's Report on Oral Health

The Surgeon General's (SG's) report will provide an opportunity to describe oral health and provide the backdrop to present the case for the critical inter-relationship between oral health and general health.

AGENCY SPONSOR: National Institute of Dental and Craniofacial Research

FEDERAL CONTACT: Kleinman, Dr. Dushanka

PIC ID: 6861

PERFORMER: National Institutes of Health
Bethesda, MD


Vaccine Development: Establishing Priorities for the United States for the 21st Century

This evaluation will undertake a detailed assessment of vaccine research and development needs and priorities for the upcoming decade. The committee will then apply the model to general priorities for domestic vaccine development for the next ten to twenty years.

AGENCY SPONSOR: National Institute of Allergy and Infectious Diseases

FEDERAL CONTACT: Rabinovich, D. Regina, M.D.

PIC ID: 5984

PERFORMER: National Academy of Sciences
Washington, DC