Clinical Research: NIH Has Implemented Key Provisions of the Clinical Research Enhancement Act
Published: 2002-09-18T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: Clinical research is critical for the development of strategies for the prevention, diagnosis, prognosis, treatment, and cure of diseases. Clinical research has been defined as patient-oriented research, epidemiologic and behavioral studies, and outcomes research and health services research. The National Institutes of Health (NIH) is the principal federal agency that funds clinical research supporting individual clinical investigators, clinical trials, general and specialized clinical research centers, and clinical research training. For many years, there have been concerns that clinical research proposals are viewed less favorably than basic research during the peer review process at NIH and that clinical research has not received its fair share of NIH funding. In November 2000, the Clinical Research Enhancement Act was enacted to address some of these concerns. NIH reports that it has increased its financial support of clinical research and that spending on clinical research has kept pace with total NIH research spending. NIH has taken some steps to improve its peer review of clinical research applications. The Center for Scientific Review recently added two new peer review study sections for the review of clinical research applications--one for clinical cardiovascular science and other for clinical oncology. NIH has increased its support of general clinical research centers, as required by the act, although the program has grown more slowly than NIH's overall estimated expenditures on clinical research. NIH has established the four clinical research career enhancement award programs mandated by the act. Three of these programs have been implemented, and they support new and midcareer clinical investigators and institutional clinical research teaching programs. The fourth program is designed to support graduate training in clinical investigation. NIH has initiated a new extramural loan repayment program specifically for clinical investigators as required by the act. This program was launched in December 2001. NIH received 456 applications by the February 2002 deadline. Twenty-one of NIH's institutes plan to fund 396 loan repayment contracts, for a total of $20.2 million, by the end of fiscal year 2002.

section_title: Letter
paragraphs: Clinical research is critical for the development of strategies for the  prevention, diagnosis, prognosis, treatment, and cure of diseases. Clinical  research has been defined as patient-oriented research, epidemiologic and  behavioral studies, and outcomes research and health services research.  In contrast, basic biomedical research involves fundamental investigations  that do not focus directly on patients or their diseases. The National  Institutes of Health (NIH) is the principal federal agency that funds clinical  research, supporting individual clinical investigators, clinical trials,  general and specialized clinical research centers, and clinical research  training. NIH’s total budget grew dramatically from about $12.8 billion in  fiscal year 1997 to an estimated $23.6 billion in fiscal year 2002. NIH’s 27  institutes and centers (ICs) each receive separate appropriations and  accomplish their missions through intramural research (government  scientists conducting research at NIH’s own laboratories and clinics) and,  to a greater extent, through extramural research (scientists conducting  research at institutions outside of NIH). Scientists compete for funding  from NIH, and research proposals are evaluated for their eligibility for  funding by peer review study sections of primarily nonfederal scientists.
As NIH’s overall budget has grown, more attention has focused on its  support of clinical research. For many years there have been concerns that  clinical research proposals are viewed less favorably than basic research  during the peer review process at NIH and that clinical research has not  received its fair share of NIH funding. Also at issue have been the declining  numbers of physician-investigators and the challenges they face, such as  inadequate clinical research training and high debt from educational loans.  In November 2000 the Clinical Research Enhancement Act (CREA) was  enacted to address some of these concerns. The act directed NIH to  consider recommendations from earlier studies for enhancing clinical  research and to support and expand its resources for clinical research in  general and in specific ways. The act also mandated that we evaluate  NIH’s implementation of its provisions. To that end, we determined  whether and how NIH has (1) increased its funding of clinical research  and expanded its clinical research activities, (2) improved its review of  clinical research proposals, (3) supported general clinical research centers  (GCRC) and expanded their activities, (4) established new clinical  research career development and training programs, and (5) implemented  a loan repayment program for extramural clinical investigators.
To assess NIH’s progress in complying with the requirements of CREA, we  reviewed NIH documents and data on clinical research expenditures, peer  review of clinical research, clinical research training and career  development award programs, and the clinical research loan repayment  program. We also interviewed officials at several offices and institutes  within NIH, including the Office of the Director, the Center for Scientific  Review (CSR), the National Center for Research Resources (NCRR), and  other institutes. Finally, we interviewed and consulted with key  stakeholders, including the Association of American Medical Colleges  (AAMC), the Institute of Medicine’s (IOM) Clinical Research Roundtable,  and other clinical research experts. The scope of our report was restricted  to NIH’s implementation of CREA, and we did not evaluate the  effectiveness of NIH’s actions in promoting clinical research. NIH took  some actions required by CREA prior to its passage. For this reason, we  looked at all relevant actions taken by NIH, not just those initiated since  November 2000. We conducted our work from December 2001 through  August 2002 in accordance with generally accepted government auditing  standards.
subsections: section_title: Background
paragraphs: In the 1990s, a number of influential studies sponsored by NIH, IOM, and  AAMC and the American Medical Association (AMA) identified some  major problems in clinical research and highlighted NIH’s role in  addressing some of these problems. First, there was a general concern  that clinical research was receiving substantially less support than basic  research at NIH, yet there was little systematic data to document how  much, in fact, NIH was spending on clinical research. In an analysis of NIH  investigator-initiated extramural grants active in 1991, an IOM committee  found that 16 percent involved human research. A few years later, a panel  appointed by the NIH director known as the “Nathan Panel,” developed a  broad definition of clinical research (the definition NIH now uses) and,  applying this definition to all NIH competing extramural research grants in  fiscal year 1996, found that 27 percent of grants and 38 percent of dollars  were devoted to clinical research. The Nathan Panel believed that this  fraction of the extramural budget devoted to clinical research was  reasonable and should remain about the same, as efforts to increase the  NIH budget as a whole were pursued. The studies sponsored by NIH, IOM,  and AAMC/AMA recommended that NIH monitor and track its  expenditures on clinical research.
A second concern was that clinical research proposals, especially those  from individual investigators, did not fare as well as basic research  proposals in peer review at NIH. Grant applications for clinical trials,  clinical research centers, and clinical research training are typically  reviewed by the sponsoring institute; however, the peer review of  individual investigator grant applications usually takes place centrally,  within CSR. CSR has approximately 65 study sections that review  research. A study section is a panel of experts established according to  scientific disciplines or research areas for the purpose of evaluating the  scientific and technical merit of grant applications. In 1994 an NIH- commissioned study reported that patient-oriented research applications  were less likely to receive favorable reviews in CSR than laboratory- oriented research applications when reviewed in study sections with less  than 30 percent patient-oriented research applications. However when  patient-oriented research applications were grouped in study sections with  greater than 50 percent patient-oriented research, they fared as well as  laboratory-oriented research applications. Consequently, this report  recommended that study sections reviewing patient-oriented research  should have at least 50 percent of such applications and that a means  should be developed and implemented to collect and track data  prospectively on research applications that are predominantly patient- oriented, laboratory-oriented, mixed, or clinical epidemiology and  behavioral research. Similarly, the Nathan Panel recommended that panels  that review clinical research must include experienced clinical  investigators and that at least 30 to 50 percent of the applications reviewed  by these panels must be for clinical research. The IOM committee also  recommended more oversight of study section composition, functions,  and outcomes pertaining to human research.
A third problem identified in these studies was the adequacy of support for  the infrastructure (that is, facilities, equipment, data systems, and research  personnel) for the conduct of clinical research. Since the late 1950s, NIH  has funded GCRCs across the U.S to provide clinical research  infrastructure—facilities, equipment, and personnel—for NIH-funded  investigators as well as non-federally funded investigators conducting  patient-oriented research. Interdisciplinary and collaborative research is  encouraged at these centers. The Nathan Panel, the IOM committee, and  others recommended increasing financial support for GCRCs and  broadening their leadership role in clinical research and research training.
A fourth concern was the decline in the number of physicians conducting  clinical research. According to data collected by the AMA, the number of  physicians reporting research as their primary career activity fell by 6  percent from 1980 to 1997 (from 15,377 to 14,434), while the number  reporting patient care as their primary career activity almost doubled  (376,512 to 620,472). Observers identified a variety of challenges in  pursuing a career as a clinical investigator, including the indebtedness of  medical students, the length of time a clinical scientist must train, the  culture of academic medicine, as well as the competition from other  career options. For many years NIH has supported the training of  investigators through extramural and intramural predoctoral, postdoctoral  training and career development awards. However, there was concern that  these awards were being directed toward basic research and were not  sufficiently supporting the training and development of clinical  investigators. The IOM committee, the Nathan Panel, and the AAMC/AMA  reports recommended that NIH provide substantial new support for  clinical research training, career development, and debt relief.
section_title: Growth in NIH’s Spending on Clinical Research Has Kept Pace with Total Spending
paragraphs: NIH reports that it increased its funding of clinical research and expanded  its clinical research activities in response to CREA. NIH estimates that it  spent about one-third of its budget, or approximately $6.4 billion, on  clinical research in fiscal year 2001. Based on these estimates, the  proportion of the NIH budget spent on clinical research has remained  fairly constant since fiscal year 1997. NIH’s estimates of clinical research  expenditures represent the best available indications of financial trends  over time, but they are not precise figures because the process of counting  clinical research dollars varies widely across ICs. Finally, in response to  CREA, some NIH ICs have developed specific clinical research initiatives.
subsections: section_title: NIH Estimates That It Spends about One-Third of Its Budget on Clinical Research
paragraphs: In fiscal year 2001, NIH estimated that it spent approximately $6.4 billion  on clinical research, which represented about 32 percent of total research  spending (see table 1). The institutes that spent the most on clinical  research in fiscal year 2001 were the National Cancer Institute (NCI); the  National Heart, Lung, and Blood Institute (NHLBI); and the National  Institute of Mental Health (NIMH) (see app. I). NIH’s estimated  expenditures on clinical research have kept pace with the overall growth  in NIH’s budget. As NIH’s reported clinical research expenditures  increased by 44 percent (adjusted for inflation) from fiscal year 1997 to  fiscal year 2001, the proportion of research dollars spent on clinical  research remained constant, at 32 percent, each year.
NIH estimates that in fiscal year 2001, it spent approximately $5.9 billion  on extramural clinical research, about 35 percent of its total extramural  research expenditures. NIH’s extramural clinical research dollars were  spent through a variety of funding mechanisms in fiscal year 2001. About  40 percent of the awarded dollars were grants to individual investigators,  followed by other funding mechanisms, center grants, cooperative  agreements, research program projects, and research and development  contracts (see fig. 1). Of NIH’s total extramural research expenditures for  cooperative agreements and center grants, the majority of dollars were  spent on clinical research in fiscal year 2001.
In fiscal year 2001, NIH estimated that it spent about $529 million, or   27 percent of its intramural research expenditures, on clinical research.  NIH’s intramural clinical research activities include research at the  Clinical Center on NIH’s Bethesda, Maryland, campus, as well as research  by individual institutes. The Clinical Center’s budget represents more than  half of the intramural clinical research expenditures. The budget of the  Clinical Center increased from approximately $204 million in fiscal year  1997 to an estimated $303 million in fiscal year 2002. This budget increase  supported an increase in admissions, inpatient days, and outpatient visits.
section_title: Flaws Exist in NIH’s Process of Counting Clinical Research Expenditures
paragraphs: NIH’s reports of clinical research expenditures represent the best available  indications of financial trends, but are not precise figures. The methods  NIH uses to count clinical research dollars are inconsistent across ICs,  potentially underestimating or overestimating its actual clinical research  expenditures. Since fiscal year 1997, the Office of Budget, within the Office  of the Director, has collected information from each IC on its extramural  and intramural clinical research expenditures. The ICs use the NIH  definition of clinical research (described earlier), but they count the  dollars in very different ways. The 20 ICs that fund clinical research  reported three different ways of counting clinical research dollars. First,  12 ICs count 100 percent of the grant dollars of research projects that  include any clinical research. Second, one institute, NCI, codes a research  project’s “percent relevance” to clinical research. Projects are coded as  100 percent, major, minor, or 0 percent clinical research. If they are  classified as “major,” they are assigned a percentage relevancy of 50  percent, and 50 percent of the dollars are counted. If they are classified as  “minor,” they are assigned a percentage relevancy of 5 percent, and 5  percent of the dollars are counted. Third, 7 ICs either attempt to estimate  the dollars of a research project spent on clinical research or the  percentage of a project that is clinical research and apply that percentage  to the total grant dollars.
These different methods of counting clinical research dollars can produce  very different results. For example, given a hypothetical grant to an  investigator of $300,000 for which an IC has estimated that $50,000 of the  budget would be spent on clinical research, some ICs would report that  $300,000 was spent on clinical research; NCI could conclude that this grant  has only minor relevance to clinical research and therefore would count 5  percent, or $15,000, as clinical research dollars; the rest of the ICs would  estimate that this project is about 17 percent clinical research and  therefore count $50,000 of the grant as clinical research dollars.
The Office of Budget said that the reason the ICs count clinical research  dollars differently is that each developed its own methods over time, and  for historical consistency, they are reluctant to change. One IC director,  who heads an NIH Director’s committee concerned with clinical research  spending told us that NIH is working on ways to make its process of  tracking and reporting clinical research dollars more consistent and  accurate.
section_title: NIH Institutes Have Developed New Clinical Research Initiatives
paragraphs: In response to CREA, some institutes have developed new clinical  research initiatives. For example, since the passage of CREA, NCI has  funded two new clinical cancer centers and funded 22 new Specialized  Programs of Research Excellence for different types of cancer, all of  which involved early phase clinical trials. NHLBI is establishing new  clinical research centers to study ways to reduce racial and economic  disparities in asthma prevalence, treatment, and mortality and is funding  trials to assess innovative strategies to improve the implementation of  clinical practice guidelines for heart, lung, and blood diseases. The  National Institute of Arthritis and Musculoskeletal Diseases has a new  osteoarthritis initiative; funds multidisciplinary clinical research centers in  arthritis, musculoskeletal, and skin diseases; and plans to enhance its  translational research projects in children’s diseases. The National  Institute of Allergy and Infectious Diseases (NIAID) has continued to fund  large clinical trial networks such as the AIDS Clinical Trials Group, a   $120 million per year initiative that involves research on pediatric and  adult AIDS.
section_title: NIH Has Taken Steps to Improve Its Peer Review of Clinical Research
paragraphs: Since passage of CREA, NIH has acted to strengthen its peer review of  clinical research applications. CSR established two new study sections in  the areas of clinical oncology and clinical cardiovascular sciences. In  study sections with a mix of clinical and basic proposals, CSR tries to  group clinical research applications and reviewers, but officials could not  provide data to determine how successful it has been in achieving this  goal. NIH has established peer review mechanisms at the institutes for the  review of career development and training awards established under  CREA.
subsections: section_title: CSR Has Established Two New Clinically Focused Study Sections for Peer Review
paragraphs: In response to concerns that clinical research proposals are not fairly  reviewed in its study sections, CSR has established two new clinically  oriented study sections, Clinical Oncology and Clinical Cardiovascular  Sciences. In these scientific areas, CSR found that there were a sufficient  number of clinical research applications to justify separate study sections.  Although the two new clinical research study sections have been  welcomed by the research community, some concerns remain among  clinical investigators about the fairness of the review of clinical research  by other study sections that have a mix of clinical and basic research. In  these study sections, CSR officials told us they try to group clinical  research applications and clinical research reviewers. CSR officials told us  that it is their general goal to review clinical research applications in study  sections in which at least 30 percent of the applications involve clinical  research and in which at least 30 percent of the reviewers are themselves  clinical investigators. CSR officials also explained that this goal cannot  always be achieved because if the number of clinical research applications  in a specific scientific area is small, it may not be possible to group the  applications to 30 percent and still review them in a study section that  provides the appropriate scientific context for review. They emphasized  that reviewing applications in the appropriate scientific context is given  priority over quantitative targets for grouping. CSR officials could not  provide data on the extent to which they have been able to group clinical  research applications and have very limited data on which reviewers are  clinical investigators. The officials told us that, to date, they do not have  reliable and accurate methods for identifying and tracking clinical  applications or clinical reviewers.
CSR officials told us they are in the process of a broader review and  restructuring of their peer review system, with input from the scientific  community, to account for new developments in science. According to  CSR, one of the goals of this reorganization is grouping applications and  reviewers at 30 percent so that there is a “density of expertise” in review  sections. In addition, CSR has recently appointed a special advisor on  clinical research review to serve as a liaison with the clinical research  communities.
section_title: Clinical Research Career Development and Training Applications Are Reviewed by ICs
paragraphs: To determine NIH’s response to CREA’s requirement that NIH establish  appropriate mechanisms for the peer review of clinical research career  development and training applications, we surveyed nine ICs that  sponsored the highest number of clinical research career development  awards in fiscal year 2001. We found that three ICs used a Special  Emphasis Panel, while the six others used established committees or  subcommittees to review clinical research career development and  training applications. In addition, the ICs reported that most of the  reviewers of these applications have clinical research experience, and  some are involved in clinical research training. One institute brings in  temporary reviewers to augment its committee if special expertise is  needed. NCRR uses CSR for peer review of some career development  applications that require very specific scientific expertise and therefore  require review by the discipline-specific study sections of CSR.
section_title: NIH Has Increased Its Support and Scope of GCRCs
paragraphs: NIH has increased its support of GCRCs and GCRCs’ scope of work, as  required by CREA. The GCRC budget has grown over time, although more  slowly than NIH’s estimates of clinical research spending. Adjusted for  inflation, the funding for GCRCs increased by 24 percent from fiscal year  1997 to fiscal year 2001, compared to a 44 percent estimated increase in  clinical research spending at NIH during that same period. Although NIH  has stopped funding some GCRCs, there has been a gradual increase in the  number of GCRCs over time, from 74 in fiscal year 1997 to 79 in fiscal year  2001. There has also been an increase in the activities of GCRCs and some  expansion in their scope since passage of CREA.
subsections: section_title: Funding, Number, and Activities of GCRCs Have Increased
paragraphs: NIH has increased funding for the GCRC program, although funding for  the GCRCs has grown more slowly than NIH’s estimate of overall  expenditures on clinical research. From fiscal year 1997 through fiscal  year 2001, funding for the GCRCs increased from $153,521,000 to  $220,824,000 (see table 2). Adjusted for inflation, this represents an  increase of 24 percent, compared to the 44 percent estimated growth in  total clinical research expenditures during this period. The number of  GCRCs gradually increased during this period, from 74 to 79. Funding  levels for individual GCRCs in fiscal year 2001 ranged from $712,339 to  $6.2 million, with an average funding level of about $2.8 million. NIH  officials told us that in fiscal year 2002, they are opening two new GCRCs,  one at the University of Maryland and one at the University of Miami.  Establishing a new GCRC costs about $2.5 million and requires a certain  threshold of investigators. Once a GCRC is set up, attracting additional  investigators and research activities is easier, according to NIH officials.
Also shown in table 2, some activities of GCRCs have increased in recent  years. For example, the number of research protocols and investigators  supported by GCRCs increased from fiscal year 1997 through fiscal year  2001. While the number of inpatient days funded by GCRCs declined from  70,814 in fiscal year 1997 to 62,769 in fiscal year 2001, the number of  outpatient visits increased from 282,125 to 334,828 during the same period.
section_title: Scope of GCRC Activities, Including Telecommunications, Has Expanded
paragraphs: Since passage of CREA, NIH officials told us there has not been a change  in the mission of GCRCs, but there has been an increase in the scope of  GCRC activities. For example, in fiscal year 2002, 27 GCRCs have funded  Clinical Research Feasibility pilot projects to support the research of  beginning investigators. In addition, 76 GCRCs now each have a Research  Subject Advocate who helps ensure that GCRC research is conducted  safely and protects human research subjects.
CREA required that NIH expand the activities of the GCRCs through  increased use of telecommunications and telemedicine initiatives. In  response, NIH officials told us they increased their support of specialized  bioinformatics networks that electronically link research data across  GCRCs. Specifically, NCRR established a Biomedical Informatics Research  Network, a computerized network that allows investigators affiliated with  GCRCs to share high-resolution images of human brains and large volumes  of complex data and conduct remote analysis of the data. In fiscal year  2001, NCRR funded five bioinformatics centers at $2.1 million, and a  coordinating center at $1.6 million, spending a total of $3.7 million on this  initiative. In fiscal year 2002, $6 million has been set aside to extend this  network. NCRR also funded a collaborative pilot project between the  Cystic Fibrosis Foundation and several GCRCs, called CFnet, to assess  whether clinical trials could be facilitated across GCRC sites with Web- based data handling. Based on the success of this pilot, NCRR plans to  extend CFnet to 20 GCRCs and also establish a comparable network  among the eight U.S. medical schools that have a high proportion of  minority students to facilitate the schools’ participation in clinical trials  that relate to health disparities.
section_title: NIH Has Increased Its Support of Clinical Research Career Development and Training
paragraphs: NIH has established the four new career development award programs  required by CREA. Three of these have been implemented, and the fourth  is just beginning. NIH has also established intramural and extramural  clinical research training programs for medical and dental students and  clinical research continuing education programs as required by CREA.
subsections: section_title: NIH Has Implemented Three Award Programs for Career Development of Clinical Investigators
paragraphs: NIH recently established three new clinical research career development  award programs for individuals and institutions outside government that  are designed to increase the supply and expertise of clinical investigators  (see table 3). NIH used its K award mechanism, its usual method for  providing support for career development of investigators, to establish  these programs. In fiscal year 1999, NIH implemented the Mentored  Patient-Oriented Research Career Development Award (K23) to support  investigators who are committed to conducting patient-oriented research  for 3 to 5 years. In the same year, NIH implemented the Mid-Career  Investigator Award in Patient-Oriented Research (K24) to provide support  for more senior clinicians to relieve them of patient-care duties and  administrative responsibilities so that they can conduct patient-oriented  research and serve as mentors for beginning clinical investigators. The  Clinical Research Curriculum Award (K30), also implemented in fiscal  year 1999, supports the development and expansion of clinical research  teaching programs at institutions. About half of the K30 programs offer  graduate degrees in clinical research (for example, masters or doctorate).
The response to these new award programs was substantial, and NIH  funded more awards than originally planned. NCRR and the largest  institutes (for example, NCI, NHLBI, and NIMH) sponsored the highest  number of the new K23 and K24 awards. NHLBI is administering the  majority of the K30 awards. Although NIH has received applications for  K23 and K24 awards from a variety of clinical investigators, most  applicants and awardees are physicians. The K30 awards have primarily  gone to academic medical centers. The new awards combined represent  25 percent of expenditures NIH allotted for all K awards under its Career  Development Program in fiscal year 2001 (see fig. 2).
NIH officials told us that they are initiating plans to evaluate the new  clinical research career development awards and track career outcomes.  The design of this assessment will be based on previous studies of training  award recipients, specifically NIH’s study of the outcomes of the National  Research Service Awards (NRSA) and will rely on NIH’s new electronic  grant application.
section_title: Size and Scope of New Award Program for Graduate Training in Clinical Research Is Limited
paragraphs: In 2001 NIH announced a fourth new clinical research career development  award, the Mentored Clinical Research Scholar Program (K12). This award  program, sponsored by NCRR and linked to the GCRCs, is NIH’s response  to CREA’s directive to support graduate training in clinical research.  NCRR decided to start the K12 program as a small pilot project and then  expand it later if successful. In fiscal year 2002, NCRR received 43  applications for this award and expects to fund 10 of these. In the first  year of the program, each funded award may enroll three clinical research  scholars, for a total of 30 scholars. NIH projects that the number of  scholars could grow to 120 in 5 years.
We interviewed several K30 program directors who indicated that  obtaining graduate tuition and stipend support for their students and  prospective students was a major constraint. The K30 award, which has  been well received in the research community, funds curriculum, staff, as  well as tuition and other costs in special circumstances, but generally does  not directly support students. Instead, students must seek funding from  other NIH, federal, or private sources. An NIH official estimated that the  number of formal trainees in individual K30 programs ranges from several  to three dozen. This official was not able to provide data on whether these  students had tuition support and what kind of support. However, the K30  program directors we talked to said some of their students had tuition  support from other NIH funding mechanisms; others had support from  their university. Although the new K12 program is consistent with the  requirements of CREA, some K30 program directors and other experts  believe the size and scope of the program will be too small to meet the  need for graduate training support for clinical investigators.
section_title: Other NIH Clinical Research Training Programs Targeted toward Medical and Dental Students
paragraphs: In terms of fellowships for clinical research training, in fiscal year 2001,  NCRR announced a new mentored medical student clinical research  program that will support a small number of medical and dental students  at GCRCs. This program provides supplemental grants to GCRCs to offer 1  year of support for medical and dental students, usually from their third  through fourth year of school, in the form of salary, supplies, and tuition  assistance. A total of five students may eventually be supported at each  GCRC site annually, although NCRR plans to provide support for only one  medical student per GCRC in fiscal year 2002.
Since 1997, NIH has also trained medical and dental students at its campus  in the area of clinical research. In this program, partially supported by a  pharmaceutical company, 15 to 20 students are selected each year and are  each paired with a mentor for a year of academic study and clinical  research experience.
section_title: NIH Has Established an Extramural Loan Repayment Program for Clinical Investigators
paragraphs: NIH has launched an extramural loan repayment program for clinical  investigators as required by CREA, and most of NIH’s ICs participate in the  program. In the first year of implementation, eligibility for the loan  repayment program was tied to receipt of NIH funding. However, in fiscal  year 2003, NIH plans to extend eligibility to allow clinical investigators  who receive funding from other sources, such as other federal agencies  and nonprofit foundations, to apply.
subsections: section_title: New Extramural Loan Repayment Program Established by NIH
paragraphs: In response to CREA, NIH established an extramural Clinical Research  Loan Repayment Program. This new loan repayment program joins four  other extramural loan repayment programs and four intramural loan  repayment programs that are administered by NIH’s Office of Loan  Repayment and Scholarship. The new extramural Clinical Research Loan  Repayment Program was implemented on December 28, 2001, and a total  of 456 applications were received by February 28, 2002. NIH plans to fund  396 loan repayment contracts for a total of $20.2 million by the end of  fiscal year 2002. The program provides for the repayment of up to $35,000  per year of the principal and interest of an individual’s educational loans  for each year of obligated service. These individuals are obligated to  engage in clinical research for at least 2 years. The clinical research loan  repayment program represents a sizeable proportion (almost two-thirds)  of the total extramural loan repayment program budget.
To be eligible for the clinical research loan repayment program, a clinical  investigator must have received an NIH research service award, training  grant, career development award, or other NIH grant as a first-time  principal investigator or a first-time director of a subproject on a grant or  cooperative agreement. In fiscal year 2003, the Director of the Office of  Loan Repayment and Scholarship told us that NIH plans to remove the  NIH-funding restriction and allow clinical investigators who receive  funding from other sources, such as other federal agencies and nonprofit  foundations, to apply for the loan repayment program. In addition, NIH  expects to almost double the size of the extramural Clinical Research Loan  Repayment Program in fiscal year 2003.
section_title: Twenty-one of NIH’s ICs Participate in the Loan Repayment Program
paragraphs: Although NIH has a central office that administers all the loan repayment  programs, funding for the clinical research loan repayment program was  distributed to the ICs, based on reported clinical research expenditures in  fiscal year 1999. Thus 21 of NIH’s 27 ICs plan to participate in the program  by reviewing applications and awarding loan repayment contracts (see  app. II). The ICs sponsoring the highest number of contracts are NCI,  NHLBI, and NIMH. NCRR also plans to sponsor a significant number of  loan repayment contracts. As with most of the training and career  development awards, an NIH official told us that the ICs were in the best  position to assess applications and the clinical research career potential of  awardees.
section_title: Conclusion
paragraphs: In general, NIH has complied with the key provisions in CREA. It has  increased its financial support of clinical research, expanded its clinical  research activities, made improvements in its review of clinical research  proposals, expanded its support of GCRCs, established new clinical  research career development and training programs, and begun to  implement a new extramural clinical research loan repayment program.  Some of NIH’s actions were taken prior to CREA’s passage and some are  still being implemented. However, we identified some inconsistencies with  the way that NIH counts clinical research expenditures. These  inconsistencies limit the precision of NIH’s reports of clinical research  expenditures and its ability to monitor the support of clinical research.
section_title: Recommendation for Executive Action
paragraphs: To strengthen the tracking and reporting of intramural and extramural  expenditures for clinical research, we recommend that the Director of NIH  develop and implement a consistent, accurate, and practical way for all  ICs to count intramural and extramural clinical research expenditures.
section_title: Agency Comments
paragraphs: NIH reviewed a draft of this report and provided comments, which are  included as appendix III. NIH concurred with our recommendation and  reported that it is taking steps to implement a better, more unified system  for tracking and reporting clinical research expenditures across the ICs.  According to NIH, this new system will be implemented in fiscal year 2003.  NIH also provided technical comments, which we incorporated as  appropriate. In particular, NIH clarified its response to our questions  about the peer review of clinical research. NIH emphasized that it  recognizes the importance of collecting data on the grouping of clinical  research applications and reviewers. Toward that end, NIH stated that one  of the responsibilities of CSR’s newly appointed Special Advisor on  Clinical Research Review will be to investigate new methods to reliably  identify and track clinical research applications and clinical research  reviewers.
We will send copies to the Secretary of Health and Human Services, the  Director of NIH, appropriate congressional committees, and others who  are interested. We will also make copies available to others on request. In  addition, the report will be available at no charge on GAO’s Web site at  http://www.gao.gov.
If you or your staffs have any questions, please contact me at   (202) 512-7119 or Martin T. Gahart at (202) 512-3596. Key contributors to  this assignment were Anne Dievler, Cedric Burton, and Elizabeth  Morrison.
section_title: Appendix I: NIH’s Estimated Expenditures for Extramural and Intramural Clinical Research, by IC, Fiscal Years 1997 - 2001
subsections: section_title: Dollars in millions
section_title: Appendix II: NIH’s Extramural Clinical Research Loan Repayment Contracts by IC, Fiscal Year 2002
subsections: section_title: Institutes and centers National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute on Drug Abuse National Center for Research Resources National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development National Institute on Alcohol Abuse and Alcoholism National Institute of Neurological Disorders and Stroke National Institute of Arthritis and Musculoskeletal and Skin Diseases National Eye Institute National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Human Genome Research Institute National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Nursing Research National Center for Complementary and Alternative Medicine John E. Fogarty International Center Total
section_title: Appendix III: Comments from the National Institutes of Health