Liver and biliary diseases affect Americans of all ages and walks of life, with considerable impacts on the personal, economic, and societal levels. As the newly appointed NIDDK Director, I am committed to vigorous, multi-pronged research efforts with regard to liver disease and the many other debilitating diseases within the Institute's mission. I am pleased to share with the liver disease research community my vision for the Institute over the next few years, with specific examples with respect to this field of research. At all levels of the NIDDK organization, we will continue to pursue the most compelling research to combat the many forms of liver disease, including diseases that affect the liver, gallbladder, and biliary tract. Moreover, we will remain firmly committed to basic, translational, and clinical research; research training and career development; and the dissemination of health information to improve the lives of patients, their families, and those at risk for developing these diseases.
Together, we in the NIDDK will build upon the emerging opportunities that are the fruits of past research investments. Through careful planning and analysis, we will use our budgetary resources to sustain research momentum and capitalize on research achievements. In moving research forward, the following core principles will guide my leadership.
Maintain a Vigorous Investigator-Initiated Research Portfolio: The innovativeness and problem-solving capability of individual investigators are crucial for research progress. Therefore, the NIDDK will maintain funding of investigator-initiated grants at the highest possible level. The Institute currently sustains strong investigator-driven portfolios in such areas as basic liver biology, liver development and regeneration, and liver and biliary pathophysiology, including studies relevant to conditions such as viral hepatitis, fatty liver disease, and gallstones. We will also maximize our investments by supporting cross-cutting science. For example, the NIDDK supports efforts focusing on inflammation as a common disease mechanism and on biomarker development--two areas of major relevance to diseases within the liver and biliary system, as well as other organ systems. The NIDDK will continue to strongly support investigator-driven studies, which have yielded abundant insights into liver and biliary health and disease through explorations into areas such as liver inflammation and fibrosis, liver regeneration signals, factors controlling bile acid transport and gallstone formation, and strategies for combating hepatitis virus infection.
Support Pivotal Clinical Studies and Trials: Clinical studies will continue to be an integral component of NIDDK-sponsored research. The NIDDK supports multi-site clinical research into many liver and biliary conditions. Examples include clinical trials of hepatitis C therapy in affected patient populations, studies of acute liver failure and liver transplantation, and clinical networks focusing on non-alcoholic fatty liver disease and drug-induced liver injury. Researchers are pursuing clinical studies to conquer liver and biliary diseases that affect children, including efforts to identify contributors to fatty liver disease and possible therapeutic strategies, uncover the causes of acute liver failure, and improve approaches for liver transplantation. A key goal is to find ways to prevent liver damage from occurring in the first place, and to prevent its progression in patients who are already experiencing impaired liver function. Through the work of research consortia in which investigators share their talents and resources, we are building upon past advances to identify new genetic factors that influence the development of biliary and liver diseases in children, as well as new approaches to diagnosis and treatment. The NIDDK will seek ways to maximize these investments in clinical liver disease research by expanding access to research resources through ancillary studies to large clinical trials, and through repositories of biological samples that can aid the investigative community.
Because some liver diseases place a disproportionate burden on minority populations, we will continue to seek insights and answers to health disparities. For example, the NIDDK supports a clinical study aimed at discovering why African Americans with hepatitis C are less responsive to treatment than Caucasian Americans. This research involves minority participants and study leaders.
Preserve a Stable Pool of Talented New Investigators: The ideas and fresh perspectives of new investigators invigorate the liver disease research community. Through fostering mentorship and promoting special consideration for funding, we will strive to ensure that new investigators can realize their potential for contributing to biomedical research. We are also taking steps to encourage today's generation of young scientists to view liver and biliary disease research as a viable career.
The NIDDK has created a number of special opportunities for new investigators. For example, over the past several years, applications from new investigators for regular research grants (R01 grants) received a two percentile point advantage in funding consideration compared to applications from established investigators. More recently, new investigator applications that have just missed our general funding line--commonly called the "payline"--have received individual consideration for possible award through an approach we term "special emphasis funding." NIDDK Program Directors also give new investigator applications special consideration for short-term support (R56 awards) to help explore a research concept that was proposed in an initial application that scored outside the payline. This type of award helps investigators collect preliminary data in order to submit a revised, stronger R01 application for a longer-term regular research grant.
The NIDDK also has a vigorous research career development award program for scientists who are at early stages of their careers. These opportunities will be complemented by NIDDK's participation in NIH-wide efforts to support new investigators, such as through the NIH Pathway to Independence Program and the NIH Loan Repayment Program. The NIDDK's Division of Digestive Diseases and Nutrition regularly co-sponsors workshops for new investigators given career development awards. At these workshops, staff members meet with attendees and discuss the workings of the NIH, and senior investigators from the hepatology community provide grant-writing suggestions and career advice. Another way the NIDDK supports junior investigators in their transition to independence is through an ongoing initiative that allows career development awardees (those with K08 and K23 awards) to apply for a small research grant to expand upon their career award project, demonstrate independence from their mentor, and gain grant-writing experience.
Foster Exceptional Research Training and Mentoring Opportunities: Maintaining an NIDDK-focused pipeline of outstanding investigators is critically important to our progress in liver disease research. To this end, we offer programs for individuals who are different stages in their careers--ranging from those who have already attained advanced degrees to those who are very early in their educational development.
We will continue to support significant opportunities at the graduate-student and postdoctoral levels, as well as research career development awards and undergraduate research educational paths. Opportunities are provided to ensure that we have a cadre of well-trained PhD scientists, as well as physician scientists specializing in hepatology. For example, the NIDDK's Division of Digestive Diseases and Nutrition supports a vigorous program of research training grants for predoctoral students and postdoctoral fellows. The NIDDK Liver Diseases Branch also sponsors a program for training medical fellows for careers as physician scientists in hepatology. Such fellows have made major contributions to both basic and clinical research in the field of liver diseases. Up-and-coming scientists are supported by mentored career development awards, and more senior researchers are supported by mid-career development awards to provide mentorship to clinical investigators. We encourage minority investigators to apply for all of our research training and career development awards and also support a Network of Minority Research Investigators to further their long-term academic research careers. NIDDK staff members also participate in numerous career workshops and national scientific meetings throughout the year to disseminate information on funding opportunities in liver disease research.
Ensure Knowledge Dissemination Through Outreach and Communications: We are continuing efforts to ensure that the science-based knowledge gained from NIDDK-funded research is imparted to health care providers and the public for the direct benefit of patients and their families. For example, a wealth of materials is available through the National Digestive Diseases Information Clearinghouse on a wide range of liver disease topics, including gallstones, viral hepatitis, fatty liver disease, autoimmune and genetic forms of liver disease, and liver transplantation. Additionally, liver disease research advances and profiles of patients living with liver and biliary conditions are part of a yearly compendium prepared by the Institute entitled "NIDDK: Recent Advances and Emerging Opportunities."
Importantly, as we plan for the future and address resource allocation challenges, we will continue to seek and value external advice from professional scientific organizations, patient advocates, investigators, and the public. Key sources of input include our National Advisory Council, Interagency Coordinating Committees, strategic planning processes, ad hoc planning groups, and scientific conferences and workshops. Of particular note is the ongoing implementation of the 10-year, trans-NIH Action Plan for Liver Disease Research, which was developed with extensive community input under the auspices of the statutory Digestive Diseases Interagency Coordinating Committee and released in 2004. The National Digestive Diseases Commission is currently deliberating to fulfill its charge of developing a long-range research plan for the field, with a section of the plan devoted to diseases of the liver and biliary system. This section will build upon the recommendations in the Liver Disease Action Plan. The NIDDK also sponsors conferences and workshops to facilitate dissemination of research findings and foster planning to advance future liver disease research. Recent meetings have focused on acute liver failure, biliary atresia screening, and improving outcomes of pediatric liver transplantation. For 2008, the NIDDK is planning an NIH Consensus Development Conference on hepatitis B management, which will address issues specific to groups at higher risk such as Asian Americans/Pacific Islanders. Stakeholder input from these and other planning processes will provide a useful scientific guidepost to inform our long-range strategic directions and program-development efforts. Active collaboration with other components of the NIH and other federal agencies will also remain a cornerstone of NIDDK planning efforts.
Ever-increasing knowledge and the advent of new technologies bring new scientific opportunities for alleviating and conquering the liver and biliary diseases within the NIDDK's mission. We will continue to support research that will further evidence-based medicine and will promote the translation of research discoveries into medical practice for the direct benefit of patients. Through these efforts, we aim to reduce the burden of liver disease and improve the nation's health. To this end, I look forward to working with the NIDDK's many stakeholders.
For general information on the NIDDK:
http://www.niddk.nih.gov
For information from the National Digestive Diseases Information Clearinghouse:
http://digestive.niddk.nih.gov
For information on funding opportunities for new investigators:
http://www2.niddk.nih.gov/Funding/Grants/Resources_NewInvestigators.htm
For information on training and career development opportunities:
http://www2.niddk.nih.gov/Funding/TrainingCareerDev
For a copy of the Action Plan for Liver Disease Research:
http://liverplan.niddk.nih.gov
For information on the National Commission on Digestive Diseases:
http://www.niddk.nih.gov/federal/ncdd/index.htm