October 5, 2009
Dear Colleagues and Friends:
The National Children’s Study (NCS) is the largest and most complex longitudinal study ever undertaken to examine environmental and genetic influences on human growth, development and health outcomes. Since January 2009, the study has been in a pilot or feasibility phase, termed the Vanguard Study, at selected Vanguard Study Centers. The NCS Program Office has analyzed the Vanguard Study experience to date and based on this analysis, several changes will be implemented to ensure that the NCS will accomplish its scientific and public health goals aligned with the highest scientific, ethical and fiscally responsible standards.
The Vanguard Study will focus entirely on assuring the feasibility, acceptability and determining the cost of the procedures and data collections being considered for the Main Study. The Main Study will focus on data collection and addressing hypotheses related to the environment, genetic, growth, development and health outcome interactions. Feasibility refers to the technical performance of the study infrastructure and all the assessments scheduled to occur. The term assessment refers to evaluation of the tests, measures and specimen collections performed at each study visit. Acceptability refers to the impact of each visit and each assessment on the participants, study personnel and NCS infrastructure. Cost refers to the time, money, number and type of personnel and effort required.
The Vanguard Study will continue for the same length of time as the Main Study, but always by a time interval, currently estimated as about two and a half years, ahead of the Main Study with the purpose of developing and refining the operations and assessments that will be in the Main Study. There is no intent to merge data between the Vanguard Study and the Main Study because they have different objectives and the assessments in the Main Study will be selected from and may be modified from those in the Vanguard Study.
The selection of assessments to include in the Main Study will be a four step process. The first step is evaluation of technical performance, reliability and reproducibility. For all assessments that meet these criteria, a second step will be a selection based on how informative and how valuable the information is relative to other assessments. The third step will be to select those assessments that are the most specific and avoid redundancy with other types of assessments. Finally, and perhaps most important, the assessment must address a question that has potentially important public health impact, requires a study of the size and robustness of the NCS, and is unlikely to be answered in another context. The entire selection process will be guided by the NCS Program Office and vetted through the Interagency Coordinating Committee, the NCS Advisory Committee and the NIH scientific community to ensure the highest quality scientific and public health advice.
By proceeding in this manner, the NCS will be best able to provide the data that can be analyzed to address important scientific and public health questions. As such, and until we know the portfolio of visits and visit assessments to be included in the Main Study, any and all scientific and public health hypotheses are candidates to inform the portfolio of qualified study assessments. The determination of the design of the final protocol for the Main Study will be based on a combination of the most important scientific questions to be addressed and the ability of the data collection techniques and assessment tools to provide valid answers. The NCS Main Study also will remain available as a platform for additional assessments, data collection and analyses through the Adjunct Study program.
If you have questions, feel free to send an e-mail to firstname.lastname@example.org. Thank you.
Steven Hirschfeld, MD PhD
Captain U.S. Public Health Officer
Operations Chief and Chief Medical Officer
USPHS Rapid Deployment Force-1
Associate Director for Clinical Research
Acting Director, National Children’s Study
Eunice Kennedy Shriver National Institute of Child Health and Human Development