APPENDIX B
NATIONAL INSTITUTES OF HEALTH SUPPORT OF RESEARCH IN DEPARTMENTS OF OBSTETRICS AND GYNECOLOGY*

ROBERT A. WALKINGTON

The National Institutes of Health (NIH) is the major supporter of biomedical research conducted in the nation's universities and medical schools. In 1989, 60 percent of funds for biomedical research in academic institutions came from NIH, compared with 8 percent from private, non-profit sources and 6 percent from industry.1 In medical schools, over 75 percent of funds for sponsored research comes from the federal government, the majority from NIH.2 NIH support in FY 1989 included over $500 million for clinical trials, $245 million to support research training, $90 million for career development awards and $120 million to support beginning researchers.3 Since it is peer reviewed in national competition, NIH support is considered a standard of excellence. For this reason it can be used to leverage other support: from the community, from private sources and from industry.

For more than a decade there has been concern that clinical research is not adequately supported. This is thought in part to be because physician-scientists are relatively unsuccessful in winning NIH peer awards. The following comments are indicative of interwoven concerns.

*  

 This paper was prepared for the Institute of Medicine, Committee on Research Capabilities of Academic Departments of Obstetrics and Gynecology.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 269
Strengthening Research in Academic OB/GYN Departments APPENDIX B NATIONAL INSTITUTES OF HEALTH SUPPORT OF RESEARCH IN DEPARTMENTS OF OBSTETRICS AND GYNECOLOGY* ROBERT A. WALKINGTON The National Institutes of Health (NIH) is the major supporter of biomedical research conducted in the nation's universities and medical schools. In 1989, 60 percent of funds for biomedical research in academic institutions came from NIH, compared with 8 percent from private, non-profit sources and 6 percent from industry.1 In medical schools, over 75 percent of funds for sponsored research comes from the federal government, the majority from NIH.2 NIH support in FY 1989 included over $500 million for clinical trials, $245 million to support research training, $90 million for career development awards and $120 million to support beginning researchers.3 Since it is peer reviewed in national competition, NIH support is considered a standard of excellence. For this reason it can be used to leverage other support: from the community, from private sources and from industry. For more than a decade there has been concern that clinical research is not adequately supported. This is thought in part to be because physician-scientists are relatively unsuccessful in winning NIH peer awards. The following comments are indicative of interwoven concerns. *    This paper was prepared for the Institute of Medicine, Committee on Research Capabilities of Academic Departments of Obstetrics and Gynecology.

OCR for page 269
Strengthening Research in Academic OB/GYN Departments ''Whether for lack of time, expectation of greater funding, more ability to control variables or other reasons, the physician-investigator has turned away from involvement in human research. Obtaining funding for human studies is considered so difficult that many investigators are discouraged and in some instances, bitter."4 "Concerns of insufficient access to research support have been voiced by a variety of individual surgical investigators. Frustrated by a perceived inability to successfully compete for NCI grant support, some surgical oncologists have criticized aspects of the current NCI peer-review mechanisms for awarding grants."5 "It is essential to understand that in 1988 it is effectively impossible for an individual investigator to obtain NIH funding for human investigation."6 "If I leave here (Intramural Program) I will leave research" [because its impossible to get a grant for clinical research].7 "Friedman told the board that clinical investigators do complain that is very difficult to get RO1 grants: 'The perception is that they receive poorer priority scores and inferior funding', he remarked. 'If one looks at...comparisons by program...it's evident, that year by year, there are inferior funding rates for the clinical proposals compared to the preclinical proposals' Friedman stated. 'This does not indicate whether the proposals are good or not'; 'I would argue that some of them are [good]. What we need is [the submission of] more good clinical proposals.'"8 The evidence to support these concerns is mixed. Different studies, using different data bases and or time periods, have produced different results. A study conducted at NIH in the early 1980s showed that between 1976–1981 only 63 percent of clinical applications were approved compared with 74 percent of basic science applications. The study also found that approved clinical applications received poorer priority scores than did those dealing with basic research.9 M.D. applicants in 1985 had a higher disapproval rate (9.1 percent) than Ph.D. applicants (6.8 percent). During the decade 1975–1985, Ph.D.s had consistently slightly better priority scores than M.D.s on competing RO1 applications. 10 Recent NIH data, however, indicate that between 1987 and

OCR for page 269
Strengthening Research in Academic OB/GYN Departments 1989 M.D.s had slightly higher success rates than Ph.D.s in competing for research-project grants, of which the majority are RO1s.11 A 1986 study indicated that between 1975 and 1985 the number of ROI applications from M.D.s and M.D./Ph.D.s increased by 30 percent, compared with an increase of 83 percent in applications by Ph.D.s. The proportion of new applications submitted by M.D.s dropped from 31 percent of total R01 applications in 1975 to 25 percent in 1986. There is also concern that the number of physicians in clinical research is declining, though conclusive data are lacking.12,13,14,15, 16,17 Particular concern is expressed over the shortage of physicians involved in patient oriented clinical research. Reasons suggested for the decline include: increasing indebtedness of medical school graduates; increasing difficulty of maintaining competency in both science and medicine; perceived insecurities associated with extramural research funding for clinical investigation; problems associated with financial soundness of academic departments combined with increasing demands for faculty to engage in clinical practice; expectations with less willingness to undergo relative deprivation; the paucity of role models and inadequate mentoring; and curriculum deficiencies in medical schools.18 In addition to the general problems related to NIH support of clinical research and the physician-scientist, specific concerns have been expressed about the paucity of research conducted in departments of OB/GYN. The IOM Planning Committee for the current study concluded that departments of OB/GYN lagged in receiving support from NIH for research and speculated that: "possible causes related to the politicalization of problems relating to the status of the fetus, lack of organizational focus for reproductive research at NIH, the lack of a national consensus concerning the ethical issues raised by some reproductive research ... there is also the possibility that the absence of OB/GYN presence in the NIH intramural program results in a relative disregard of OB/GYN research."19 NIH support appears to be hindered by three interrelated problems: 1) the quality of the research being proposed 2) the nature of the research, and 3) the

OCR for page 269
Strengthening Research in Academic OB/GYN Departments organizational structure and management of NIH in general and with regard to the review of grant proposals. There are a few studies that illuminate the quality of OB/GYN research, or research proposals: In 1986, research grant applications (competing RO1s) from OB/GYN departments had the poorest average priority scores of nine clinical departments studied—a decline from FY 1979 when OB/GYN ranked in the middle (5th of 9) of the clinical departments studied.20 A study focusing on clinical oncology support from the National Cancer Institute showed that between FYs 1980 and 1985 OB/GYN departments had success rates substantially lower than departments of medicine, pediatrics and radiology. While the success rated varied greatly from year to year, for 3 of the 6 years the rate for OB/GYN was substantially lower than that of the other departments. The decline in success rates between 1980 and 1985 was greater for OB/GYN than the three other departments studied.21 A measure of the research intensity of a department is the degree to which faculty are involved in research. A 1989 Association of American Medical Colleges (AAMC) study, analyzed the distribution of full-time faculty of U.S. medical schools who are principal investigators on NIH or Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) research awards by department and degree. The study linked the AAMC Faculty Roster (1988)—with records of NIH and ADAMHA research awards (FY 1987). This linkage allowed awards made to affiliated hospitals to be credited to the appropriate department. OB/GYN departments ranked 11th of 17 clinical departments with 9.8 percent of their faculty being principal investigators, compared with an average of 14 percent for all clinical departments. Examination of the data by the degree of the principal investigator reveals that the discrepancy between OB/GYN and more research intensive departments can be attributed to the M.D. and M.D./Ph.D. faculty. Ph.D.s in OB/GYN departments are principal investigators at a rate above the average for all clinical departments (Ph.D.s in OB/GYN departments ranked 6th of 17 clinical departments; M.D and M.D/Ph.D.s ranked 12th). (Table B-1).22 According to a 1986 survey of academic manpower in OB/GYN departments, almost all the Ph.D. faculty and 61 percent of the M.D. faculty reported involvement in research.23 A survey in 1990 asked faculty to indicate if they spent at least 20 percent of their time in research. Although 92 percent of the Ph.D. faculty indicated that they were so involved, only 38 percent

OCR for page 269
Strengthening Research in Academic OB/GYN Departments TABLE B-1: Percentage of Full Time Faculty, in Clinical Departments Who are PIs on NIH/ADMHA Awards (1988)   Total Full Time Faculty Total M.D.s Department No. %PIs No. %PIs Opthalmology 1,014 36.5 650 25.7 Neurology 1,637 23.9 1,101 18.4 Dermatology 365 22.5 291 20.0 Int. Medicine 13,448 19.9 10,894 17.7 Pathology 1,152 17.0 656 13.9 Public Health 1,127 15.7 445 10.6 Other Clinical 69 14.5 21 19.0 Otolaryngology 543 14.2 296 6.4 Pediatrics 5,724 13.4 4,503 11.9 Psychiatry 5,244 12.1 2,858 8.1 OB/GYN 2,265 9.8 1,687 5.9 Surgery 5,031 9.5 4,038 7.0 Radiology 3,884 8.3 2,786 3.2 Orthope. Surgery 730 7.8 569 4.4 Anesthesiology 2,649 3.5 2,186 1.6 Phy. Med/Rehab. 548 1.2 341 0.9 Family Medicine 1,539 1.2 1,127 0.7 Total/Average 45,969 14.0 34,449 11.1

OCR for page 269
Strengthening Research in Academic OB/GYN Departments   Total M.D./ Ph.D.s Total Ph.D.s Department No. %PIs No. %PIs Opthalmology 61 39.3 245 69.4 Neurology 148 37.8 315 35.6 Dermatology 22 40.9 43 34.9 Internal Medicine 875 31.1 1,261 33.9 Pathology 122 25.4 280 22.1 Public Health 48 14.3 472 25.0 Other Clinical 2 0.0 41 12.2 Otolaryngology 28 25.0 171 27.5 Pediatrics 275 28.4 614 21.8 Psychiatry 197 18.8 1,728 20.2 OB/GYN 126 13.5 320 32.2 Surgery 268 17.9 540 25.9 Radiology 169 13.6 696 29.0 Orthope. Surgery 23 13.0 81 34.6 Anesthesiology 181 8.8 157 22.3 Phy. Med/Rehab. 18 5.6 97 6.2 Family Medicine 25 0.0 265 6.8 Total/Average 2,589 24.3 7,327 26.9   SOURCE: AAMC Medical School Faculty Roster (1988) linked with IMPAC record of research grants (NIH and ADAMHA) and Contracts (NIH) that received funds during FY 1987. of the M.D. faculty were.24 Because of differences in the wording of questions the two surveys are not comparable. Roughly comparable data exist for departments of internal medicine. A study in the early 1980s indicated a more intense involvement in research of physician faculty in departments of internal medicine than in departments of OB/GYN in 1990, with 50 percent of internal medicine faculty with an M.D. degree spending at least 20 percent of their time

OCR for page 269
Strengthening Research in Academic OB/GYN Departments engaged in research. Seventy seven percent of the faculty with Ph.D. degree spent at least 10 percent of their time in research.25 Although data are not available on the level of NIH support for research in reproductive issues, or for women's health in general, there are strongly held views about the interest of NIH in those topics. It should be remembered that human embryo research cannot be supported by federal funds. The following comments from letters from chairman of departments of OB/GYN to the IOM committee indicate some concerns: ''Funding has been confused by the political turmoil surrounding sex education, abortion and contraception. Because of this departments must seek funding outside the federal government; pharmaceutical and equipment companies etc. or find clinical income to support research". "Funding has moved from NIH and NSF to pharmaceutical companies with interests in product development. Some types of clinical research (sohographic studies of the fetus in utero) are impossible to fund through NIH, despite their importance. These studies are conducted with support from clinical income, but not at the standard of peer reviewed funding". In addition to the political, and ethical ramifications of some areas of OB/GYN research, many OB/GYNs in medical schools believe that NIH lacks interest in reproductive issues and women's health in general. Again, comments from some department chairmen indicate these concerns: "Lack of NIH commitment to women's health research is evidenced by composition of study sections, no separate institute and few NIH OB/GYNs". "The governance of NIH is neither responsive nor interested in women's issues. They will only act if they think they can direct funds to other specialties. An example is the lack of representation by chairman of OB/GYN departments in the governing councils of the NIH. The NIH Advisory Committees are comprised of approximately 3,056 individuals; of those only 26 are OB/GYNs yet the most common cause for admission to most acute hospitals are in OB/GYN. I would agree with the GAO that arrogance and indifference summarize the attitude of the NIH towards women's issues and departments of OB/GYN. The NIH is not "national" in that is not representative of

OCR for page 269
Strengthening Research in Academic OB/GYN Departments the nation or its health issues, as more than half of the nation are women". The data and beliefs cited indicate a need to examine more closely what has been happening to OB/GYN departments in the competition for funds, and a need to indicate where one might seek change to improve the outcome. NIH Support for OB/GYN Research Overview "Federal funding of research in academic departments of OB/GYN in the United States has never been substantial and the situation is no different today."26 In FY 1978, the majority of federal support for OB/GYN departments came from the Department of Health, Education and Welfare (DHEW), now the Department of Health and Human Services, with a small amount coming from the Agency for International Development. Of the money from DHEW, over 90 percent came from NIH with small amounts from ADAMHA and the Bureau of Maternal and Child Health. The picture in FY 1989 was similar, with HHS providing the large majority of federal support, and most of that coming from NIH. Figure B-1 shows total NIH support for OB/GYN departments in both current and constant (1968) dollars. Growth in constant dollars has been modest, from $7 million in 1968 to $12 million in 1989 (71 percent). Between 1968 and 1989 OB/GYN departments slightly increased their share of NIH funds—current dollar support to OB/GYN departments grew by 570 percent while overall NIH research support grew by only approximately 550 percent. Between 1978 and 1989, support to OB/GYN departments increased by approximately 190 percent while overall NIH support grew by approximately 150 percent. The increased support of departments of OB/GYN in the 1980s is actually more impressive than the percentages indicate since the two institutes providing the majority of the support the National Institute of Child Health and Human Development (NICHD) and the National Cancer Institute (NCI) both had budget increases below the NIH average for the decade.

OCR for page 269
Strengthening Research in Academic OB/GYN Departments Figure B-1: NIH support of departments of OB/GYN, current and constant (1968) dollars. SOURCE: Special tabulation by NIH. OB/GYN departments received a fairly constant share of NIH funds going to medical schools—1.5 percent in 1968, 1.4 percent in 1978 and 1.5 percent in 1989. OB/GYN faculty received approximately 2.7 percent of the NIH/ADAMHA awards to clinical departments.* However, the departments received slightly less than would be expected on the basis of size of faculty, since OB/GYN departments had approximately 3.7 percent of the total full time medical schools faculty and 4.8 percent of the flail time faculty in clinical departments in 1988. *   It should be noted that these figures understate the actual funds going to OB/GYN departments. This is caused by the fact that the NIH data system does not allocate funds awarded to separate administrative units to the department even though the research may be directly related. Thus if a medical school has a center for reproductive research or population studies which is not administratively part of the OB/GYN department, research conducted in the center will not appear in the departmental total. However, there is no reason to believe this under reporting has increased over time or is more common for OB/GYN departments than for other clinical departments and thus should not effect longitudinal or cross department comparisons.

OCR for page 269
Strengthening Research in Academic OB/GYN Departments NICHD has been the major NIH supporter of OB/GYN departments, providing 69 percent of support in 1968, falling to 56 pete t in 1978, returning to 69 percent in 1989. Support from the NCI fell from 31 percent in 1978 to 9 percent in 1989, although in 1989 it was still the second largest NIH funder of OB/GYN departments. The National Institute of Allergy & Infectious Diseases (NIAD) increased its support of OB/GYN departments, mostly because of a $1.7 million contract to study prenatal transmission of HIV. The Heart, Lung and Blood Institute (NHLBI) and the Division of Research Resources (DRR) also showed major increases, the latter due largely to a grant and a cooperative agreement with Emory University for "support of animal resources available to all qualified investigators without regard to scientific disciplines or disease orientation." (Table B-2). TABLE B-2: NIH Support of Departments of OB/GYN By Institute, FYs 1968, 1978, 1989 Institute 1968 1978 1989 NICHD $4,793,336 $8,977,923 $32,023,354 NCI 823,276 4,997,132 4,362,099 NHLBI 213,314 451,276 1,859,406 NIA — 448,292 774,409 NIADDK 898,441 930,580 1,656,883 NIDR 16,000 187,040 — FIC 10,661 77,541 55,496 NIGMS 73,265 59,114 389,055 NIDCDS — 15,200 1,013,612 NIAID — — 2,494,911 DRR 120,031 — 946,000 NIEHS — — 796,639 NEI — — 161,632 Total NIH Support 6,948,324 16,144,098 46,533,496 Percent of NIH Support to Medical Schools 1.5 % 1.4% 1.5%

OCR for page 269
Strengthening Research in Academic OB/GYN Departments Table B-3 shows competitive and noncompetitive NIH awards to OB/GYN departments, 1980–1989, by number and type of award (later tables reflect only competitive awards—new or competing continuations). OB/GYN department support more than doubled ($22.8 million to $46.5 million), however, since the size of awards increased, the number of awards increased more modestly. The number of research grants increased, but the number of contracts declined from 11 to 7, although contract dollar support more than doubled. Awards for training grants and fellowships combined fell in both number and dollars. These trends generally reflect the overall NIH experience during the decade. TABLE B-3: Total NIH Awards to OB/GYN Departments (By Major Type) Thousands of Dollars 1980–1989   Total Awards Research Grants Contracts Year No. $ No. $ No. $ 1980 246 22,764 202 20,676 11 1,373 1881 236 26,084 212 24,444 8 1,256 1982 232 26,009 203 23,871 9 1,601 1983 233 28,978 200 25,792 13 2,713 1984 251 33,479 222 29,869 11 3,112 1985 246 36,415 222 33,383 9 2,525 1986 256 36,947 222 34,563 10 1,694 1987 275 41,902 250 39,493 9 1,943 1988 272 45,454 247 44,602 9 3,184 1989 258 46,533 235 42,678 7 3,229

OCR for page 269
Strengthening Research in Academic OB/GYN Departments the past six years more than two thirds of the awards have been either K08s or K11 (in approximately equal numbers). Number of Individuals in Departments of OB/GYN with NIH Training Support It is difficult to determine the number of people in departments of OB/GYN whose research training has been helped by NIH support. While NIH codes data on the recipients of traineeships and fellowships on its records, and also has data on career development awards, those at NIH most familiar with these data files do not consider them to be reliable. However, by using several different files and source some approximate numbers can be generated: Physicians m OB/GYN departments received 18 competing career development awards between 1980 and 1989 (individuals normally receive support for two to four years). In addition to individual awards there was one institutional K award during the decade, thus roughly 20 OB/GYN M.D.s were supported by NIH career development awards. In addition, nine individual physicians in OB/GYN departments received National Research Service Fellowships directly from NIH and eight OB/GYN departments received training grants from NIH. While it is not possible to determine how many individual M.D.s received support under the institutional awards, it is generally believed that most of the programs were small. This, coupled with the fact that four of the eight institutional grants were made in FY 1988 for awards to begin in FY 1989, make it unlikely that more than 20 to 25 individuals received support under the training program during the decade of the 1980s. Adding together the career development "K" awards (seventeen individuals, one institutional award) and the research training awards (nine individual fellowships and eight training grants under the National Research Service Awards Program) it is likely that approximately fifty OB/GYNs received research training from NIH during the decade of the 1980s. Beginning Research Awards To help new biomedical researchers develop from working under a mentor to independence, NIH uses the R-29 grant, the First Independent Research Support and Transition (FIRST). These grants are designed "... to underwrite the first independent investigative efforts of an individual; to provide a reasonable opportunity to demonstrate creativity, productivity, and further promise and to help in the transition to traditional types of NIH research project

OCR for page 269
Strengthening Research in Academic OB/GYN Departments grants".27 The grants are for 5 years, are not renewable, are limited to $350,000 in total and $100,000 in a single year. The R-29 (FIRST grants) replaced similar R-23 grants in the mid 1980s, therefore departmental comparisons below include both types of awards. In 1989, 1,711 R-29 awards were made in the amount of approximately $152 million. This represents an increase from 0.8 percent of the NIH extramural research budget in 1980 ($20 million) to 2.7 percent in 1989. Like several other grant mechanisms, OB/GYN and radiology made little use of R-23 and R-29 grants between 1980 and 1989. OB/GYN submitted few applications and had low success rates, which declined during the second five years of the decade. OB/GYN had the lowest success rate of the five departments for both the periods, 1980–1984 and 1985–1989 (Table B-13). The number of applications from M.D.s, presents a similar picture to that for traineeships and fellowships, although it is not as extreme. Over half of the R23/R29 grants from departments of pediatrics, medicine and surgery came from M.D.s, while only 31 percent of those from OB/GYN departments and 13 percent of those from radiology were from M.D.s. M.D.s from OB/GYN had success rates significantly lower than any of the comparison departments. Institutional Grants In addition to individual awards, NIH supports larger multi-project research efforts. The two most important are program projects (P01s) and research centers, a generic term which includes a number of different types of centers-specialized, core, comprehensive, animal, and general clinical research centers. Program project grants (PO1s) are broad-based, long term multidisciplinary research activities organized around a basic theme. The individual sub-parts or components '...must have scientific merit and essential elements of unity and interdependence that constitute a system of research activities and projects directed toward the overall goal of the program". These grants involve large numbers of researchers and in addition to supporting the interrelated research projects can also support both basic resources and clinical components used by the overall group. The number of program project grants awarded and funding rose in the past decade. The number of awards increased from 535 to 793 and funding increased from $297.5 million to $683 million. While few in number, compared for example to RO1s, they are the second largest grant in terms of funding.

OCR for page 269
Strengthening Research in Academic OB/GYN Departments TABLE B-13: Success Rates of R23 and R29 Applications, Selected Clinical Departments, 1980–1989 Department Number of Applications No. of Awards Success Rate All Applications OB/GYN 165 29 17.6% Medicine 1,909 652 34.2* Pediatrics 607 189 31.1* Radiology 181 68 37.6* Surgery 411 122 29.7* Total 3,273 1,060 32.4 M.D.s OB/GYN 51 4 7.8% Medicine 1,024 345 33.7* Pediatrics 344 114 33.1* Radiology 23 7 30.4* Surgery 213 60 28.2* Total 1,655 530 32.0 * Significant at 95 % confidence level when compared with OB/GYN. Between 1980 and 1989 OB/GYN departments were relatively successful in the competition for program project grants (P01), with success rates failing approximately in the middle of the five comparison departments (Table B-14). The number of applications from each department is small and none of the differences between OB/GYN and the other four departments is statistically significant. With the exception of an increase in the number of applications from departments of medicine there are no discernable trends over the decade. In fact the most significant fact about OB/GYN performance with regard to P01s is the small number of applications—on average less than 3 per year and a total for the decade of only 28. This is only a quarter of the number submitted by

OCR for page 269
Strengthening Research in Academic OB/GYN Departments radiology, the department with the next fewest applications. Since program project grants are only awarded to institutions with developed research programs, the small amber of applications may indicate that few OB/GYN departments believe they have the research programs that would allow them to compete successfully. Research center grants together are the third largest grant activity in terms of dollars awarded. While there are 10 different types of center grants, the two largest are the specialized (P50) and the core (P30) which between them accounted for approximately 60 percent of the number and 57 percent of the dollars for center grants in 1989. The core grants (P30s) are designed to provide "... shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort or from the same discipline who focus on a common research problem".28 Specialized centers (P50s), on the other hand, not only provide supportive ancillary activities but also provide support for an overall set of research activities to mount "... a multidisciplinary attack on a specific disease entity or biomedical problem area.29 These latter grants are similar to program project grants except that awards are usually based on specific announcements from an NIH institute or division and are more closely monitored by NIH. The number of new center grants NIH can award is limited by Congress which also earmarks some specific center programs to receive awards. In some years in the 1980s, congressional floors on the number of RO1s reduced the number of center grants made by NIH. OB/GYN departments were competitive for P30 and P50 grants, having had the highest success rate of any of the five departments between 1980 and 1989. However OB/GYN departments submitted on average only three applications per year (Table B-14). Of the five departments only departments of medicine made major use of center grants, submitting 71 percent of applications during the decade. Like program project grants (P01s) center grants are difficult to obtain. In general such grants go only to institutions with a successful research track record.

OCR for page 269
Strengthening Research in Academic OB/GYN Departments TABLE B-14: Success Rates of Program Project and Center Grant Applications, Selected Clinical Departments, 1980–1989 Department Number of Applications No. of Awards Success Rate PO1s OB/GYN 28 13 46.4% Medicine 646 336 52.0 Pediatrics 121 57 47.1 Radiology 100 47 47.0 Surgery 140 65 46.4 Total 1,035 518 50.0 P30s – P50s OB/GYN 33 24 72.7% Medicine 601 334 55.6 Pediatrics 111 54 48.6 Radiology 9 5 55.5 Surgery 90 47 52.2 Total 844 464 55.0 Summary of NIH Support of Departments of OB/GYN The previous sections presented information on NIH support of OB/GYN department research and research training activities. In this section the main points are summarized. On the positive side, between 1980 and 1989 the increase in funding of OB/GYN departments exceeded the NIH increase in funding of all clinical departments. The percentage of NIH support to medical schools received by OB/GYN departments remained relatively constant since the late 1960s, at about 1.5 percent of the total. However, by one measure OB/GYN wins less

OCR for page 269
Strengthening Research in Academic OB/GYN Departments than its share of funding—with about 4.8 percent of full-time faculty in clinical departments of medical schools OB/GYN receives only about 2.7 percent of the funds awarded by NIH/ADAMHA to clinical departments. While there is no evidence that the ability of OB/GYN departments to compete for NIH support seriously deteriorated between 1980 and 1989, there is a reason to be concerned about several aspects including the low level of NIH funding compared to some other departments, and the competitive state of physician investigators in OB/GYN department. NICHD has been, and continues to be, the major supporter of OB/GYN departments, providing nearly 70 percent of NIH funds to the departments in 1989. NCI is the second largest supporter, however, its contribution declined from approximately 30 percent in 1978 to less than 10 percent in 1989. No other institute provides as much as 5 percent of the total funding for OB/GYN departments. The total number of NIH awards to departments of OB/GYN varied from year to year between 1980 and 1989, but was slightly higher in 1989 than in 1980. The increase was in research grants (primarily RO1s), and a slight decline occurred in the number of traineeships, fellowships and research contracts awarded. The number of OB/GYN departments receiving NIH awards in any one year ranged from a high of 72 (in 1984) to a low of 67 (in 1989). It is important to remember that while the mix of M.D.s to Ph.D.s was similar in the five departments we analyzed, the mix of grant applications was not. M.D.s in the departments of internal medicine, pediatrics and surgery submitted between 58 percent and 65 percent of the departments' grant applications, and the proportion increased through the 1980s. M.D.s in departments of radiology submitted 28 percent, and those in departments of OB/GYN submitted 38 percent. M.D.s from departments OB/GYN and radiology had the fewest applications of the five departments, and for the decade OB/GYN departments had the lowest success rate. Ph.D.s from OB/GYN departments fared better, with a success rate that put them in the middle of the five departments analyzed. The picture with regard to RO1s is similar. Between 1980 and 1989, applications from OB/GYN departments had the lowest success rates (the differences in success rates between departments of OB/GYN and internal medicine and radiology were statistically significant). The success rate of RO1 applications submitted by M.D.s from OB/GYN departments were significantly lower than submissions by M.D.s in the four other departments. Ph.D.s in OB/GYN departments had a success rate below that of internal medicine and radiology and above that of pediatrics and surgery. The differences between Ph.D.s from departments of OB/GYN and Ph.D.s from departments of internal

OCR for page 269
Strengthening Research in Academic OB/GYN Departments medicine and radiology were statistically significant. The competitive position of the Ph.Ds from OB/GYN declined during the later years of the decade. OB/GYN departments were more successful in obtaining training grants and fellowships. While none of the differences are statistically significant, OB/GYN was the most successful of the five departments with regard to awards for training grants to M.D.s during the period 1980–1984. The success rate declined during the second 5 years of the decade both absolutely and relative to the other departments. A smaller percentage of the trainees in OB/GYN and radiology are M.D.s, compared with internal medicine, surgery, or pediatrics. The success rate of OB/GYN departments in winning career development awards improved during the second half of the decade rising from the lowest to the highest success rate among the five departments analyzed. This pattern holds both for all career development awards and for those going to M.D.s. However OB/GYN department M.D.s only submitted a total of 52 applications for career development awards in the 1980s. Both M.D.s and Ph.D.s from OB/GYN departments have been relatively unsuccessful in obtaining R-29 (FIRST) awards. Moreover, M.D.s submitted few applications (51 from departments of OB/GYN compared with 1,024 from departments of internal medicine). By contrast OB/GYN departments have been relatively successful in obtaining both program-project grants and center grants but submitted few such applications—on average three program-projects and three center grant applications a year between 1980 and 1989. This dearth of applications may reflect both the amount of effort required to develop these applications and the fact that NIH staff will, on occasion, discourage applications from clearly noncompetitive institutions. NIH Administration and Structure Two kinds of problems effect NIH support of research in departments of OB/GYN. One pertains to research grants submitted by M.D.s, particularly RO1s and R29s, which have a relatively low success rate. The second relates to program-project grants, center grants, career development grants, and to some degree fellowships, for which the problem is not success in obtaining funding but rather the fact that M.D.s from OB/GYN departments submit very few applications. This review is not able to determine the reasons for the low success rates and, in some programs, low application rates. The causes could be quality of

OCR for page 269
Strengthening Research in Academic OB/GYN Departments the research being proposed, the substance of the research (reproductive research and research into issues concerning women's health) or the nature of the review and the composition of the review committees. Most RO1s are reviewed in the individual study sections of the Division of Research Grants. A few RO1s, usually in response to specific announcements, may be reviewed by groups set up by the supporting institute. Of more than 50 members of the four initial review groups which together review approximately 50 percent of the applications submitted by OB/GYN departments only three list OB/GYN as a primary area of expertise and only four others listed another clinical area. This review of data pertaining to applications for funding from departments of OB/GYN does not shed light on the concern that there are characteristics of NIH that create barriers to adequate funding of OB/GYN research and women's health issues in general. These characteristics include: A paucity of women at high levels in NIH. The lack of a women's (or OB/GYN focused) institute. Lack of an OB/GYN intramural program. The pediatric orientation of NICHD's leadership. Moreover, the budgets of the two institutes that are the major funders of OB/GYN research have not grown as fast as the total NIH budget. For 8 of the 10 years between 1980–1989, NICHD had award rates for research grants below the NIH average. In 1989, 12 of the 14 institutes and other awarding units had award rates higher than NICHD. While the impact of these factors on the funding of OB/GYN is impossible to quantify, conversations with NIH staff and others indicate that some could be important. The question of why there is no OB/GYN intramural program at NIH has been asked for some years—the answers most often heard are that obstetric patient accrual would be difficult, the range of ancillary services needed would be hard to support and OB/GYNs will not work for low federal pay. While its not clear if, or how, the lack of intramural OB/GYN affects extramural OB/GYN research, some people claim that it leads to a lack of internal advocates for OB/GYN and that NIH staff dealing with OB/GYN grants feel isolated. Moreover, since the OB/GYN research community is the NIH "client" contact between NIH staff and the investigators cannot achieve the informal collegial relationship needed to generate creative thinking and ongoing excitement about the discipline. However, as a result of Congressional pressure, NICHD is planning to establish an intramural gynecological research section on campus. They are recruiting for an individual certified in gynecology to head the research program, direct its clinical consultative service and its

OCR for page 269
Strengthening Research in Academic OB/GYN Departments endocrinology fellowship program. NCI has also indicated a willingness to meet with leaders in academic gynecology to discuss the possibility of establishing a gynecology branch as well as increasing support for research in gynecological oncology. Whether it would be helpful for OB/GYN or women's health to have an institute devoted to the discipline is debatable. It is argued that relying on an institute whose primary mission is children and development relegates OB/GYN to a secondary position. This is reinforce by the tradition of having a pediatrician direct the institute. Moreover, there is a lack of visibility and organizational identification that might attract the attention of Congress to issues in OB/GYN, and allow an NIH intramural constituency to systematically develop programs. On the other hand, it is argued that a women's or OB/GYN institute would relieve the existing funders (NICHD, NCI, NIA, etc.) of the obligation to pursue OB/GYN questions, and would create a "ghetto" for OB/GYN and women's issues. In the light of ongoing developments concerning issues in women's health, such as the establishment of the Office of Research on Women's Health, and with NIH in the process of generating a research agenda for women's health, there may exist now an impetus at NIH that will allow OB/GYN and other women's health research to flourish. Actions and Further Analysis Needed to Improve NIH Support of OB/GYN Research Study is needed to examine charges that clinical research does not receive a fair scientific review at NIH. The charters of the study sections that review the majority of OB/GYN applications, their composition and the applications reviewed should be analyzed to determine whether there are problems with the composition of membership. OB/GYN academic leaders should review the career development award (Ks) and the FIRST grants (R29) to determine if there axe features of the programs that are discouraging OB/GYN participation. If such features axe found, they should meet with appropriate NIH leaders to encourage necessary changes. NIH institutes have a great range of options in how programs are structured and which mechanisms are used. It is appropriate that representatives of gynecological oncology continue to meet with NCI leadership given the institutes's decreasing support for OB/GYN research over the past decade. Given the range of women's health issues that axe the responsibility of NIA and its relatively low level of support

OCR for page 269
Strengthening Research in Academic OB/GYN Departments for OB/GYN research, it might also be appropriate for OB/GYN leaders to meet with representatives of that institute. The creation of the Office of Research on Women's Health is a positive step, and the office can play an important role as a coordinator, advocate and honest broker. It will also play a role in creating a research agenda and in monitoring the responsiveness of NIH to women's health needs. However, the major strength of NIH is in its individual institutes and increased support for OB/GYN can only come from increased awareness and support from the individual institutes. References 1. National Institutes of Health. NIH Data Book, 1990. NIH Publication No. 90–1261. September. Bethesda, Maryland. 2. Association of American Medical Colleges. 1988–1989. U.S. Medical School Finance Section for Operation Studies, July 1990. Washington, D.C.: Association of American Medical Colleges. 3. National Institutes of Health. NIH. Data Book 1990. 4. Sherman, Barry, and Myron Genel. 1983. Human Investigation in the 1980s: Themes from the Scottsdale Conference, Clinical Research 31:570–571. 5. Avis, Frederick P., Ellenberg, S. and Friedman, M. 1988. Surgical Oncology Research. Annals of Surgery. 207(3) 262–268. 6. Sherman, Barry. 1988. Position Paper Prepared for Institute of Medicine Committee. Resources for Clinical Investigation. 7. Personal Interview, 1990. 8. Health Policy and Biomedical Research News of the Week. 1990. ''Blue Sheet'', Vol. 33, No.50. December 17. 9. Cuca, J. A. 1990. Scientific, Social and Other Factors in the Evaluation of Applications for NIH Research Grants. Ph.D. Dissertation. The Catholic University of America, Washington, D.C. 10. National Institutes of Health. 1986. Peer Review Trends 1976–1985. Division of Research Grants. Bethesda, Maryland. 11. National Institutes of Health. 1990. Extramural Trends. FY 1980–1989. Division of Research Grants. Bethesda, Maryland. 12. Arias, I.M. 1989. Training Basic Scientists to Bridge the Gap Between Basic Science and Its Application to Human Disease. New England Journal of Medicine, 321:972–974. 13. Healy, B. H. 1988. Innovators for the 21st Century: Will we Face a Crisis in Biomedical Research Brainpower. NEJM. 319:1058–1064. 14. Healy, B. H. 1989. The Human Factor at the Endless Frontier. Circulation. 79:959–965. 15. Kelley, W. N. 1985. Personnel Needs for Clinical Research: Role of the Clinical Investigator. Clinical Research 33:100–104. 16. Kelley, W. N. 1988. Are We About to Enter the Golden Era of Clinical Investigation? Journal of Laboratory and Clinical Medicine 111(4):365–370.

OCR for page 269
Strengthening Research in Academic OB/GYN Departments 17. Wyngaarden, J. 1981. The Clinical Investigator as an Endangered Species. Bull New York Academic Medicine. 57(6):415–426. 18. Smith, Lloyd H. Jr. 1989. Training of Physician Scientists. Background Paper for National Research Council, Committee on Biomedical and Behavioral Personnel. Washington, D.C. National Academy Press. 19. Institute of Medicine. 1989. Research Capabilities of Academic Departments of Obstetrics and Gynecology: Report of a planning Committee. Washington, D.C. 20. National Institutes of Health. 1988. Peer Review Trends. 1976–1985. Division of Research Grants. Bethesda, Maryland. 21. Avis, Fredrick P., Ellenberg, S. and Friedman, M. 1988. Surgical Oncology Research. Annals of Surgery. 207(3)262–268. 22. Association of American Medical Colleges. 1989. Distribution of Full Time Faculty at U.S. Medical Schools who are Principal Investigators by Department. A series of tables prepared for the National Institutes of Health. Washington, D.C. 23. Pearse, Warren H., et al. 1986. Obstetric and Gynecological Manpower. Obstetrics and Gynecology. Vol. 70, No.3. Part 1. September, 1987. 24. Pearse, Warren H., et.al. Trends in Obstetric and Gynecological Academic Manpower and Research 1977–1990. (In press 1991) 25. Gentile, Nancy O., et.al. 1987. Research Activity of Full Tune Faculty in Departments of Medicine. Washington, D.C. Association of Professors of Medicine and Association of American Medical Colleges. 26. Kretchmer, Norman. 1980. The Support of Academic Obstetrics: The Public Sector in the Current Status and Future of Academic Obstetrics. Edited by John Bowers and Elizabeth Purcell. 1980. New York, NY: Josiah Macy, Jr. Foundation. 27. Association of American Medical Colleges. U.S. Medical School Finance 1988–1989. Section for Operational Studies, July 1990. Washington, D.C.: Association of American Medical Colleges. 28. National Institutes of Health. 1989. Orientation Handbook for Members of Scientific Review Group. Division of Research Grants. Bethesda, Maryland. 29. National Institutes of Health. 1989. Activity Codes, Organizational Codes, and Definitions Used in Extramural Programs. Division of Research Grants. Bethesda, Maryland.