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CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2005;3:S64–S66

unding Opportunities in Endoscopic Imaging Research

RANK A. HAMILTONivision of Digestive Diseases and Nutrition, National Institute Of Diabetes, Digestive and Kidney Diseases, National Institutes of Health,

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dvances in gastrointestinal endoscopy have greatly en-anced the clinicians’ ability to diagnose and treat manyigestive disorders. During the last 30 years, some newherapeutic endoscope techniques have become thetandard of care, and other newer evolving technologiesre being evaluated. Despite these endoscopic ad-ances, there has been expressed concern that federalunding of endoscopic research has lagged behind othervolving technologic and scientific discoveries. This arti-le provides an overview of the background of one fed-ral agency’s attempt to engage the endoscopy commu-ity in the research enterprise through a variety ofechanisms of career development, grant support, and

ndoscopic research and development.

he National Institutes of Health (NIH) and theAmerican Digestive Health Foundation jointly

ponsored a workshop1 in the winter of 1998 to addressnd identify major gaps and opportunities in endoscopicesearch. During the workshop, a body of evidence wasresented that clearly demonstrated that during the last0 years the practice of gastroenterology had been revo-utionized by the advances in endoscopic procedures andechniques. Despite these advances, there were identifiedaps in endoscopic research funding. In addition, theyroposed that a partnership of academic medical centersnd the NIH would greatly improve the quality ofatient care through enhancement of endoscopic re-earch.

The workshop identified the most compelling endo-copic opportunities in 4 main areas: (1) Barrett’s esoph-gus by using promising endoscopic technologies such ashromoendoscopy and fluorescence spectroscopy, (2) co-on surveillance by using chromoendoscopy and fluores-ence spectroscopy, (3) chronic pancreatitis by usingndoscopic approaches in the management of this con-ition, and (4) training and career development as essen-ial for the future of endoscopic research.

This jointly sponsored workshop has provided a frame-ork for National Institute of Diabetes, Digestive andidney Diseases (NIDDK) and NIH to develop initia-

ives in the area of endoscopic research and training.

urthermore, the outcome of this meeting has served as

catalyst for the gastrointestinal (GI) community andIH to develop a partnership to design and implement

trategies to improve communication about the needs inndoscopic research and evolving imaging technology.

Enhanced Funding Opportunities forEndoscopic ResearchAfter this meeting, the NIH program staff began

o develop educational workshops about research oppor-unities for NIH funding at national meetings. Withhese ongoing dialogues with the GI communities, theIH Office of the Director, acutely aware of rapid ad-

ances in medical imaging technologies, convened atate of the Science Conference on Endoscopic Retro-rade Cholangiopancreatography (ERCP) in January002.2

The panel made several recommendations in referenceo research and training. Furthermore, they reemphasizedRCP’s value as a tool for diagnosing pancreaticobiliaryiseases and that the procedure continues to hold greattility in treatment of both benign and malignant dis-ases of the pancreas and biliary tract.

In response to the recommendations of the panel, thised the NIDDK and National Cancer Institute to de-elop an initiative for a program announcement PAR3-033 entitled Endoscopic Clinical Research in Pancre-tic and Biliary Disorders. This announcement is desig-ated “special emphasis” with set aside funds for meri-orious grant proposals. The goal of this small grantsrogram is to provide flexibility for initiating prelimi-ary, short-term studies, thus allowing new ideas to benvestigated in a more expeditious manner without re-uirements for preliminary data. Such support is neededo encourage experienced investigators as well as new

Abbreviations used in this paper: ERCP, endoscopic retrogradeholangiopancreatography; GI, gastrointestinal; NBIB, National Insti-ute for Biomedical Imaging and Bioengineering; NIDDK, Nationalnstitute of Diabetes, Digestive and Kidney Diseases; NIH, Nationalnstitutes of Health; SBIR, Small Business Innovation Research; STTR,mall Business Technology Transfer.

© 2005 by the American Gastroenterological Association1542-3565/05/$30.00

PII: 10.1053/S1542-3565(05)00258-2

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nvestigators to pursue new approaches, in underdevel-ped topics, or more risky avenues of research. If suc-essful, these awards should lead to significant scientificdvances in defining the role of ERCP or newer imagingechniques in pancreaticobiliary diseases.

The research topics in this solicitation were encour-ged in the following areas: (1) comparison of interven-ional endoscopic procedures versus interventional radio-ogic approaches versus surgery for treatment of differentomplications of chronic pancreatitis, (2) studies of theole of endoscopic interventions for acute pancreatitis,hronic pancreatitis, or its complications, (3) studies ofhe role of ERCP in sphincter of Oddi dysfunctionbiliary or pancreatic sphincter), and (4) clinical studiesf the role of endoscopic and other advanced technologiesn early diagnosis, staging, or treatment of biliary orancreatic malignancy.

Career DevelopmentIn addition to enhancing the development of clin-

cal researchers that includes endoscopic researchers, aatient-Oriented Career Development Award (K23) haseen developed. The K23 provides the clinician, throughultidisciplinary didactic training, the opportunity to

btain both the knowledge and the research skills nec-ssary to compete for independent support in patient-riented research. This initiative is consistent with theecommendations of the NIH Director’s Panel on Clin-cal Research and the recommendations from the Insti-ute of Medicine Committee on Addressing Career Pathsor Clinical Research.

In addition, the NIH has adopted another award forentors in clinical research including endscopic research

alled the K24 Award. The purpose of the Midcareernvestigator Award in Patient-Oriented Research is torovide support for clinician investigators who are at thessociate Professor level or higher to allow them pro-

ected time to devote to patient-oriented research and to

able 1. Small Business Innovation Research (SBIR)

Set aside program for small business concerns to engage infederal research and development (R&D), with potential forcommercialization.

Stimulate technological innovation.Meet federal R&D.2.5% of the NIH budget is allocated.Increase private sector commercialization of innovations derived

from federal R&D for this activity.Foster and encourage participation by minorities and disadvantaged

persons in technologic innovation.Small Business Innovation Development Act of 1982.

ata from reference 3.

ct as research mentors primarily for clinical residents, D

linical fellows, and/or junior clinical faculty. This awards intended to advance both the research and the men-oring endeavors of outstanding patient-oriented inves-igators.

Small Business Innovations inResearch ProgramBecause of the rapid changes in technologies, the

IH has continued to support the use of a congression-lly mandated program to promote the development ofew endoscopic techniques called the Small Businessnnovation Research (SBIR) and Small Business Tech-ology Transfer (STTR) grant programs (Tables 1 and 2).he rationale for this program is that small biotechnol-gy firms represent a unique national resource for eco-omic growth that might be the fastest and most effi-ient mechanism to create technologic innovation toonvert cutting edge biomedical research into new tech-ology breakthroughs and competitive new products. Its believed that this should provide an opportunity for alley players in biomedical research to benefit. SBIRrants provide $850,000 (Phases I and II) or more andTTR grants provide $600,000 (Phases I and II) or moren research dollars to catalyze the commercialization ofnnovative endoscopic projects that will benefit publicealth. Furthermore, these grants offer company scien-ists an opportunity to pursue innovative projects forhich company support might not be available, and theyromote and foster partnerships with collaborators, in-luding academic investigators.

By serving as a collaborator, consultant, or principalnvestigator for STTR, an academic investigator can gainong-term financial and scientific benefits. Collaborationith a company also offers access to company resources

nd expertise and possibly jobs for graduate students andostdoctoral fellows. In a rapidly changing culture inhich research institutions are becoming more commit-

ed to innovation and entrepreneurship to enhance theconomic development of their regions, NIH SBIR and

able 2. Small Business Technology Transfer (STTR)

Set aside program to facilitate cooperative research anddevelopment between small business concerns and USresearch institutions with potential for commercialization.

Stimulate and foster scientific\technologic innovation throughcooperative research.

0.30% of NIH budget allocated for this activity.Foster technology transfer between small business concerns and

research institutions.Small Business Research and Development Enhancement Act of

1992.

ata from reference 3.

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S66 FRANK A. HAMILTON CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 3, No. 7

TTR grants can add value to an academic institution’sntellectual property. Table 3 lists some of the successtories through this mechanism.

As part of the government’s effort to improve and capi-alize on technologic advances, the National Institute foriomedical Imaging and Bioengineering (NIBIB) became

he newest of the research institutes at the NIH on Decem-er 29, 2000. The NIBIB is authorized by law HR 1795PL 106-580), which was signed by President Bill Clinton.

The mission of the NIBIB is to “improve health byromoting fundamental discoveries, design and develop-ent, and translation and assessment of technological

apabilities. The Institute coordinates with biomedicalmaging and bioengineering programs of other agenciesnd NIH institutes to support imaging and engineeringesearch with potential medical applications and facili-ates the transfer of such technologies to medical appli-ations.”3

Although still in its infancy, it is anticipated that thisnstitute will serve to augment the imaging researchctivities throughout the NIH and the academic research

able 3. Recently Funded Endoscopic Proposals ThroughSBIR/STTR Mechanism

Radiofrequency ablation of Barrett’s esophagusMultichannel gastric pacing for gastroparesisEndoscope-based B scan 200 MHZ Acoustic Microscope for in

situ histologic assessmentSimulator for ERCP training module

ata from reference 3.

ommunity. f

ConclusionOver the years, the evolving endoscopic proce-

ures and imaging technologies have greatly improvedatient care. Yet, there are many unanswered questionsbout endoscopic surveillance and the best approaches tohe management of complex GI disorders. To more effi-iently assess the evolving imaging and endoscopic tech-ologies, there is a need for partnership with the researchommunity and NIH to address the important clinicaluestions and the manpower issue in patient-orientedesearch.

As noted above, initiatives and funding opportunitiesor endoscopic research have evolved and improved overhe years. Yet there are many challenges that still faceIH and the GI community that will require continued

nteractions at national meetings to promote endoscopicesearch and the development of endoscopic researchersor the future.

References. Lieberman DA, Hamilton FA. NIH-ADHF Workshop on Endoscopy

Priorities: workshop statement and recommendations. Gastroin-test Endosc 1999;49:1–4.

. Hamilton FA. A day in court for ERCP: a plea answered. Gastroin-test Endosc 2002;56:S154–S156.

. NIH website. Available at: www.nih.gov. Accessed November 5,2004.

Address requests for reprints to: Frank A. Hamilton, MD, MPH,ivision of Digestive Diseases and Nutrition, National Institute ofiabetes, Digestive and Kidney Diseases, National Institutes ofealth, Bethesda, MD 20892. e-mail: hamiltonf@ep.niddk.nih.gov;

ax: (301) 480-8300.