Preterm Birth Causes, Consequences, and Prevention (2007) / Chapter Skim
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SECTION V Research and Policy: 13 Barriers to Clinical Research on Preterm Birth and Outcomes of Preterm Infants
SECTION V Research and Policy: 13 Barriers to Clinical Research on Preterm Birth and Outcomes of Preterm Infants
Pages 433-454
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From page 435... ...
13 Barriers to Clinical Research on Preterm Birth and Outcomes for Preterm Infants ABSTRACT The complex of interrelated biological, psychological, and so cial factors involved in preterm birth necessitate a multidisciplinary approach to research directed at understanding its etiologies, patho physiology, diagnosis, and treatment. This research must be con ducted over a sustained period of time and requires stable funding.
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From page 436... ...
436 PRETERM BIRTH and Assuring Healthy Outcomes on August 10, 2005. Although some of these barriers are common to all clinical disciplines, others are unique to obstetricians and gynecologists.
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From page 437... ...
In the area of pediatrics, a 3- to 4-year postresidency physician scientist program has been established and funded by the Association of Pediatric Department Chairs, the National Institute of Child Health and Human Development, and various foundations. Despite these efforts, a shortage of clinical researchers in the areas of perinatology, neonatology, developmental disabilities, and health services remains.
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From page 438... ...
438 PRETERM BIRTH Costs Cost is a significant barrier to the training of clinical scientists. The cost of training a doctoral student is about $200,000 over the course of 4 years of medical school, including a stipend and tuition.2 Graduate medical education funds for a residency position total at least $200,000, and then a 3year fellowship in maternal-fetal medicine or neonatology costs another $200,000.
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From page 439... ...
439 BARRIERS TO CLINICAL RESEARCH paid by an obstetrician in full-time practice. This confluence of stresses increasingly forces academic obstetrics and gynecology departments to depend on clinical revenues to pay the costs of academic programs.
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440 PRETERM BIRTH cessful role models is also essential. These research training and faculty issues are not specific to obstetrics and gynecology, neonatology, or maternal-fetal medicine.
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In those areas family physicians tend to be the obstetricians, although their numbers are dropping rapidly because of the cost of liability Insurance. Approximately 1,100 residents in obstet rics and gynecology complete their training each year.
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442 PRETERM BIRTH reers in obstetrics and gynecology show that in 2004, 74.7 percent of residents in obstetrics and gynecology were women. (In 2004, 98,000 residents and fellows were training in medical schools and teaching hospitals in the United States, of whom 40,000 were women.)
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From page 443... ...
• The 80-hour work week was implemented to improve balance between personal and professional lives for all residents. RESEARCH FOR DRUG DEVELOPMENT The development of drugs to preterm labor encounters the same challenges encountered during the development of all drugs, as well as the additional challenges of careful adherence to human subject research guidelines when they involve pregnant women and infants.
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From page 444... ...
may not demonstrate a significant health benefit for the infant, and the benefits of delaying preterm labor are greater at earlier gestational ages, but fewer of these pregnancies are available for study. In addition, it is ethically problematic to use a placebo control group in studies with pregnant women.
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From page 445... ...
Developing drugs to prevent preterm labor is an important research area, for which many barriers exist. Study design for trials of agents is a critical problem for the pharmaceutical industry.
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From page 446... ...
In particular, pinpointing the amount of funding that NIH spends on research on preterm birth is difficult because the funding is codified under a broad general category called prenatal birth-preterm low birth weight, which encompasses all research on low birth weight infants, including but not limited to those born preterm, as well as all research concerned with normal and preterm labor and fetal physiology, nutrition, and status. The separation of funding for preterm birth in particular from funding for the general category of prenatal birthpreterm low birth weight is not possible with the information on NIH funding currently available.
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From page 447... ...
447 BARRIERS TO CLINICAL RESEARCH and infants born preterm or with low birth weights and their sequelae include the following: • Administration for Children and Families • Agency for Healthcare Research and Quality -- Centers for Disease Control and Prevention -- National Center for Birth Defects and Developmental Disabilities -- National Center for Chronic Disease Prevention and Health Promotion • National Center for Health Statistics • Centers for Medicare and Medicaid Services • Food and Drug Administration • Health Resources and Services Administration -- Bureau of Primary Health Care -- Maternal and Child Health Bureau • Indian Health Service • National Institutes of Health -- National Center for Complementary and Alternative Medicine -- National Center on Minority Health and Health Disparities -- National Heart, Lung, and Blood Institute -- National Institute on Alcohol Abuse and Alcoholism -- National Institute of Allergy and Infectious Disease -- National Institute of Child Health and Human Development -- National Institute on Deafness and Other Communication Disorders -- National Institute of Dental and Craniofacial Research -- National Institute of Diabetes and Digestive and Kidney Diseases -- National Institute on Drug Abuse -- National Institute of Environmental Health Sciences -- National Institute of Mental Health -- National Institute of Nursing Research • Substance Abuse and Mental Health Services Administration ETHICAL AND LIABILITY ISSUES IN REPRODUCTION RESEARCH Many ethical issues involved in reproduction research are being discussed and debated at this time, and some may be obstacles to this research. One issue involves whether there is a benefit to the mother and her fetus of inclusion in reproduction research and whether those who are enrolled in research are better off than those who are not.
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From page 448... ...
Regulations for Protecting Human Subjects of Research Two issues that deserve focus because of the applicability of 45 CFR 46, Subpart B, are research at the threshold of viability and the ability of adolescent pregnant women to consent to research. In the 2001 revision to Subpart B, the term neonate was used as applied to research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates.
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From page 449... ...
To address these issues, some institutions have formed a specific IRB subcommittee related to pregnancy and neonatology that comprises experts in pregnancy and neonatology who review research protocols only in those areas of study. This recent innovation has streamlined the process, but it is not known how common this practice is at universities that perform obstetric and neonatal research with many participants.
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450 PRETERM BIRTH BOX 13-2 Research Involving Pregnant Women and Neonates Pregnant women or fetuses may be involved in research if all of the conditions that are listed in the federal regulations at 45 CFR 46.204 are met. There should be sufficient preclinical and clinical data to assess potential risks to pregnant women and fetuses.
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451 BARRIERS TO CLINICAL RESEARCH nates may be involved in research if the following conditions are met: neonates of uncertain viability may not be involved in research unless the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability and any risk is the least possible for achieving that objective, or the purpose of the research is the develop ment of important biomedical knowledge that cannot be obtained by other means and there will be no added risk to the neonate resulting from the research. If neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed con sent of either parent's legally authorized representative can be obtained.
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At the federal level, the Advisory Committee on Infant Mortality, established to advise the DHHS secretary on the department's programs to reduce infant mortality and improve the health of pregnant women and infants, called attention to the problem of preterm delivery and recommended the establishment of an interagency working group on low birth weight and preterm birth to stimulate multidisciplinary research, scientific exchange, and collaboration among DHHS agencies (ACIM, 2001)
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This may involve relationships with large clinical care providers to provide access to more data. A few programs have advanced from a retrospective database or chart review approach to include analysis of existing biological samples, prospective cohort studies, randomized trials, and multidisciplinary, multicenter studies.
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454 PRETERM BIRTH R01 grants, an average of 12 a year. The track record has been worse for training grants.
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