KN:
You have led the NIDDK for more than 6 years. Tell us about the institute and your vision of NIDDK’s role in promoting scientific endeavor.
Rodgers:
As the NIDDK’s director, I want to underscore the institute’s commitment to vigorous, multipronged research efforts. In particular, I want to respond to two questions I have been asked at recent meetings with NIDDK constituency groups: “How will NIDDK research move forward now and in the future?” and “How will the institute meet the challenges of the current budget landscape?”
Clearly, at all levels of the NIDDK we will continue to pursue the most compelling research to combat the many debilitating and costly chronic diseases within our mission: kidney and urologic diseases, diabetes and other endocrine and metabolic diseases, liver and other digestive diseases, nutritional disorders, obesity, and hematologic diseases. 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 these diseases.
Together, we at NIDDK will build upon the emerging opportunities that are the fruits of past research investments. Through careful planning and analysis, we will meet the challenge of deploying our budgetary resources in the most effective and efficient ways to sustain research momentum and fully capitalize on research achievements. In moving research forward, several overarching principles will guide my leadership and that of the NIDDK extramural division directors:
Maintaining a vigorous investigator-initiated research portfolio. The innovations and problem-solving skills of individual investigators are crucial for research progress. Therefore, NIDDK will maintain funding of investigator-initiated grants at the highest possible level. We will also maximize our investments by supporting cross-cutting science that is broadly applicable to many disease-specific research issues. Examples include identification of biomarkers that can aid in disease diagnosis and assessment of new treatments in clinical trials, development of cell-based therapeutic approaches for repairing damaged tissues, and the use of cutting-edge research methods to identify new candidate drugs.
Supporting pivotal clinical studies and trials. Clinical studies will continue to be an integral component of research on the broad spectrum of diseases for which NIDDK has research responsibility. We have supported large epidemiologic studies of chronic kidney disease (CKD) in adults through the Chronic Renal Insufficiency Cohort (CRIC), and in children through the Chronic Kidney Disease in Children Prospective Cohort (CKiD). Shortly, NIDDK will fund new clinical studies and trial initiatives in glomerular diseases, CKD, and end stage renal disease (ESRD). Because many of these diseases disproportionately affect minority populations, we will continue to seek insights and answers to health disparities. For example, we will continue to ensure substantial minority participation in clinical trials relevant to these diseases. We are also maximizing our investments by expanding the investigative community’s access to the valuable research resources accrued in our major clinical trials. We are doing this by funding ancillary studies to these trials and by supporting a central repository for biologic materials from clinical trials.
Preserving a stable pool of talented new investigators. The ideas and fresh perspectives of new investigators invigorate the research community. We will strive to ensure that today’s generation of young scientists can realize their potential for contributing to biomedical research and will view research as a viable career. We will foster mentorship through our K Awardee (career development) workshops and New PI workshops for first-time RO1 investigators, and promote special consideration for funding of talented new investigators through the use of differential paylines and special emphasis.
Fostering exceptional research training and mentoring opportunities. Maintaining an NIDDK-focused pipeline of outstanding investigators is critically important to our research progress. We will continue to support significant opportunities at the graduate and postdoctoral levels, as well as through research career development awards and undergraduate research educational opportunities. To ensure that we are deploying our research training resources most productively, we are analyzing data to determine the most effective aspects of training programs so that we can share them with our entire community.
Ensuring 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. Examples include the National Kidney Disease Education Program (NKDEP), the National Diabetes Education Program (NDEP), the Weight-control Information Network (WIN), and new programs to promote celiac disease awareness and the prevention of obesity in children.
As we plan for the future, we will continue to seek and value external advice from investigators, professional scientific organizations, patient advocates, and the public. Key sources of input will continue to be our National Advisory Council, Interagency Coordinating Committees, strategic planning processes like the Kidney Research National Dialogue (KRND), ad hoc planning groups, and scientific conferences and workshops. This input will provide a useful scientific guidepost as we make resource allocation decisions. 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 many chronic diseases within the NIDDK’s mission. Our continuing goal will be to seize and maximize these opportunities to reduce the burden of disease and improve the public health. To this end, I look forward to working with the NIDDK’s many stakeholders now and in the future.
KN:
What are the most important things you take into account when allocating funds, and how much discretion do NIH and NIDDK have in allocating research dollars?
Rodgers:
A substantial percentage of budget allocation is dedicated to investigator-initiated grants, in accordance with the available NIDDK payline. The proportion that goes to kidney disease thus depends on the number of applications and how well they score in review. The institute also has a process for larger (more costly) initiatives, although this has become smaller with the flattening of the NIH budget. Initiatives are proposed by KUH (kidney, urologic, and hematologic diseases) program staff and are then reviewed for scientific opportunity by the NIDDK Council. Finally, kidney investigator–initiated applications have competed successfully for Common Fund, T1D, and large-scale genetics projects. Topics include “Kidney on a Chip,” “Metabolomics in CKD,” “Systems Biology Approaches for Diabetic Nephropathy,” a cluster randomized trial in patients on dialysis that is part of an NIH health systems collaboratory, and a clinical trial to determine the value of APOL1 screening.
KN:
NIDDK spearheaded the Kidney Research National Dialogue (KRND). How has the information NIDDK gathered altered the planned Blueprint for Kidney Research?
Rodgers:
NIDDK has completed the first phase of KRND and is working on the development of the individual chapters for the “Blueprint for Kidney Research,” which also will be published as a series of individual commentaries in the Clinical Journal of the American Society of Nephrology (CJASN). Responses to the question, “What are the critical questions and objectives in kidney research?”—which numbered over 270—were broad ranging and insightful. Upon review, the collection of questions in a particular kidney research area captured the distinctiveness of each field’s critical questions. However, it has become clear that more discussions are needed to refine the content of the individual topic discussions to truly capture the current state of each field and provide high-impact conceptual models, recommendations, and potential “roadmaps.” These second-level discussions are now being completed through a hybrid structure of electronic discourse and telephone conferencing. We have taken postings from the KRND and the individual chapter commentaries into consideration during the development of current initiatives.
KN:
What will the KRND mean to individual investigators?
Rodgers:
The KRND is a good source of ideas for trainees, early stage investigators, and seasoned, established investigators who wish to think more deeply about their own research trajectory. We hope it will stimulate innovative directions that advance kidney research and aid in establishing research collaborations. Our hope is that the CJASN commentaries will effectively communicate these ideas to the broadest community possible.
KN:
Has the focus on translational research at NIH changed funding goals at individual institutes?
Rodgers:
NIDDK’s research portfolio supports a broad range of science, including patient-oriented clinical research, basic and translational research, clinical trials, pragmatic clinical trials, public health, and translation to the clinic. Translational research serves as an evolving source for new ideas and thoughtful future directions, but is only one part of the portfolio.
KN:
What do you consider the most promising translational opportunities in kidney research and practice?
Rodgers:
The most promising translational opportunities at the moment are those that pertain to glomerular disease, CKD, dialysis, and acute kidney injury (AKI). We have put forth recent funding announcements in all of these areas. We also encourage investigators and associated small start-up companies working on innovative devices, tools, and drugs to submit Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applications, as congressionally mandated funding has increased in these areas.
KN:
The percentage of funded grant applications is decreasing, and automatic spending cuts may take effect between 2013 and 2021. If automatic spending cuts go into effect, how should investigators and research institutions prepare?
Rodgers:
This is quite difficult to predict, yet it goes without saying that the high quality of research must be maintained in the face of any future spending cuts. We are attempting to support all five of our core principles as strongly as possible during periods of fiscal uncertainty.
KN:
How does NIDDK balance approaches to retain established researchers with the need to attract new researchers to the field?
Rodgers:
The NIDDK tries very hard to do both, largely through a special emphasis on funding and bridge awards for established investigators who just missed the payline, and via concerted efforts to entice undergraduate, medical school, and doctoral students to consider nephrology as a research career. We also give a special advantage to early stage investigators with a differential payline, as well as particular consideration of those who just missed the payline. We have recently hosted a mentoring workshop for our first-time R01 investigators (New PI Workshop) and are actively planning a similar one for our career development awardees (K Awardee Workshop). Finally, we just set up a Facebook page for our training and career programs (http://www.facebook.com/NIDDKKUHtrainee). We need to attract new researchers’ talent and ideas to sustain nephrology research in the future.
KN:
Many scientists and clinicians struggle to help resolve disparities in kidney disease. What are the most important recent gains in this area?
Rodgers:
There have been gains in the identification of genetic markers for risk of glomerular disease and CKD in African Americans, but significant disparities remain in outcomes. The rate of CKD in African Americans is not greater than the rate for whites, but the rate of ESRD is much higher for African Americans. I think the new genetic findings hold potential promise, but we still do not know how to operationalize them. This is an active area of investigation that may provide clinical benefits. Perhaps this will help resolve a paradoxical finding in the ESRD literature that showed despite decreased access to care and increased socioeconomic challenges, African American hemodialysis patients survive longer than white patients—an unresolved mystery that if solved could provide public health insights. The NKDEP program has been very active in finding ways to get the message out to minority communities and others with increased risk of CKD and to the providers who serve them.
KN:
In 2007 the NIDDK wrote about the economic imperative to conquer diabetes. Doesn’t the same kind of imperative exist for kidney disease?
Rodgers:
It absolutely does. The NIDDK supports a wide range of studies:
Basic science, including physiology, pathophysiology, development, injury, repair, and regeneration
Epidemiology research, such as the aforementioned CRIC and CKiD studies, and the Assessment, Serial Evaluation and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI)
Translational research, including the Diabetic Complications Consortium (DCC) and the CKD Biomarker Consortium
Clinical trials, including new RFAs in 2013 for glomerular, CKD, and ESRD clinical study initiatives
KN:
What do you consider the greatest opportunity for kidney researchers over the next decade? Could antifibrotic research not only point toward better management of kidney disease, but lead to actual regression? If so, how?
Rodgers:
I believe that over the next 10 years, we will see significant strides in the treatment of fibrosis, whether the fibrosis is a result of glomerular disease, slowly progressive CKD, or follows a bout of AKI. Recent research in animal models has pointed to many potential targets to limit, if not reverse progressive fibrosis in the kidney and other organs. We are designing a future initiative that has a long-term aim to find agents that reverse established disease—through repair, regeneration, or reversal of fibrosis.