Example of Team Science Award Nomination
Nominee: The Women’s Health Initiative Investigators
Institutions: 40 academic institutions across US with Coordinating Center at Fred Hutchison Cancer Research Center
Background: The Women’s Health Initiative (WHI) was designed in the 1993 to elucidate the etiology and prevention strategies of major causes of morbidity and mortality that uniquely or disproportionately affect postmenopausal women. The primary outcomes in WHI included cardiovascular disease (CVD), cancers of the breast and colon, hip and total fractures, and other diseases including cognitive impairment and dementia. WHI enrolled 161,808 participants (age 50-79 at enrollment) including 17% ethnic and racial minority women in one or more randomized, controlled clinical trials (CT) [hormone therapy (HT) trials of either estrogen progestin (E+P) or estrogen only (E-alone); dietary (low-fat eating pattern) modification (DM); and/or calcium plus vitamin D supplementation (CaD)] or an observational study (OS) at 40 U.S. clinical centers.
Impact: In 2002, the E+P HT trial was stopped due to excess incidence of coronary heart disease (CHD), stroke, venous thromboembolism (VTE), and breast cancer; the E-alone HT trial was stopped in 2004, just over a year early, due to excess stroke and no benefit for CHD. The DM and CaD trials continued to their planned close-outs in 2005 and demonstrated that calcium plus vitamin D supplementation slowed bone loss but did not significantly decrease fractures and low-fat dietary modification did not significantly reduce risk of cancer. As a result of these studies, recommendations for adoption of certain specific preventive health strategies for postmenopausal women has changed and oral estrogen and estrogen plus progestin use decreased by 62-76%. The Institute of Medicine Dietary Reference Index for calcium plus vitamin D supplementation was also informed by the data generated by the WHI CaD trial. With over 1000 publications, including many in top tier journals, WHI investigators have contributed substantially to our understanding of disease, and associated risk factors and mechanisms.
Support of Translational Science: What is unique about WHI relative to most established cohorts is its unwavering commitment to extending collaborative opportunities to a new cadre of clinical and translational science investigators by ensuring that the WHI data and biologic resources was widely available to the scientific community. As a result of this focused effort to enhance collaboration with scientists from multiple disciplines to participate as part of the WHI scientific team., almost 200 ancillary studies have been proposed to help delineate mechanisms related to outcomes in the trials, identify environmental influences on health and wellness or to identify new predictive biomarkers (including epigenetic and expression genetics) for more than 60 different diseases that uniquely or disproportionately occur in women.
To support the career development of the next generation of women’s health investigators, the WHI has provided FTE support to more than 80 new early career investigators with both formal and informal mentoring through the Regional Centers (RCs) and Scientific Interest Groups. Through creation of a network of biostatistics resources at the coordinating center and the 4 RCs, investigators have access to expertise on the appropriate use of the WHI dataset to support their ability to conduct WHI analyses independently or when necessary, to obtain more direct analytic support for generation of publications and ancillary studies. Pilot funding programs funded more than 20 feasibility pilot studies for the collection of preliminary data to support development and submission of ancillary studies. In addition, feasibility funds were leveraged to create two investigator-initiated questionnaires aimed at expanding data collection on outcomes, family history and health behaviors and risk factors.
Summary: WHI has a demonstrated track record of providing a nimble cost-effective infrastructure to foster a culture of interdisciplinary team science into new scientific areas. It is because of the transformative translational efforts of the WHI investigators to build upon its two decades of scientific inquiry to establish the new generation of interdisciplinary research teams that we nominate WHI for the ACTS team science award. WHI has translated research discoveries into clinical applications with dissemination and adoption into widespread clinical practice to address the most pressing questions in postmenopausal women’s health.