Building a Pediatric Clinical Research Division

Article Outline

• Creating Institutional Support
• Establishing an Administrative Structure
• Developing Synergy
• Integrating With Other Programs
• Conclusion
• Copyright

Improving child health depends on finding answers to key biological and clinical questions. These questions, in turn, are best posed by clinicians who evaluate, treat, and monitor sick children. However, it is impossible to be a truly productive and effective researcher—and be knowledgeable about state-of-the-art clinical research methodology—on top of carrying both a full-time clinical load and a part-time teaching appointment. Because of the ever-increasing sophistication of methodologies across all areas of clinical research, gone are the days when health professionals could “go it alone.”

At the University of Miami’s Miller School of Medicine, the Division of Pediatric Clinical Research is part of the larger Department of Pediatrics. 4 years ago, this new division set out to create a research infrastructure specifically devoted to studying the diseases of children. We accomplished this task by creating institutional support for this vision, establishing an administrative structure to organize our efforts, and developing synergy among our clinical and research faculty to maximize our resources. Here, we elaborate on these themes and offer suggestions to others with a similar vision.

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Creating Institutional Support 

When considering whether to start a pediatric clinical and translational research program, the institution’s commitment must be ascertained by determining how much it is willing to support research and its researchers. If the institution wants to build a quality program that is capable of conducting large, prospective, cross-disciplinary clinical studies, is funded by outside agencies, runs smoothly, efficiently, and makes the best use of limited resources, is capable of publishing in respected journals, and is largely self-supporting and flexible enough to pursue new scientific directions and changes in funding, then it must commit to creating an administrative structure that will allow these goals to be achieved. This investment will also facilitate recruitment and retention of key faculty who will advance these objectives. At the University of Miami, we received $500,000 (foundations), $50,000 (corporations), $1 million of departmental and school of medicine resources, and permission to recruit funded investigators who brought additional resources with them to create the program.

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Establishing an Administrative Structure 

Building a pediatric clinical research division requires logical, step-by-step development. The typical pediatrics department has hundreds of faculty/staff who, under the right conditions, can quickly be released to participate in some form of clinical research. The challenge is to swiftly assemble a critical mass of research professionals who have sufficient expertise and who will meet the immediate needs of the faculty/staff within the department.

The 3 basic pillars supporting a clinical research division are: 1) data management (database development, data quality checks, and audits); 2) statistics and epidemiology (study design, data analysis, interpretation, and publication of results); and 3) study implementation (case report form design, manual of operations, patient recruitment). In a young division, faculty/staff initially have duties associated with more than 1 pillar. As the division matures, faculty/staff become increasingly specialized and cross between pillars less often. With a small core of faculty/staff to fill these critical positions, the program will be jump-started within months. The Table (available at www.jpeds.com) shows our growth at the University of Miami. In conjunction with the development and implementation of our program, our Department of Pediatrics has increased the number of funded projects, increased the amount of National Institutes of Health (NIH) funding, and improved NIH research rank during the past 4 years (Figure; available at www.jpeds.com).

Table. Growth of the Division of Pediatric Clinical Research At the University of Miami

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• Figure. 

  Growth data from the University of Miami, Miller School of Medicine, Department of Pediatrics. A, Division of Pediatric Clinical Research, active research projects by year. B, Department of Pediatrics, funded projects by year. C, Department of Pediatrics, changes in NIH funding (in millions of dollars). D, Department of Pediatrics, NIH ranking among pediatric departments.

Our program supports investigators without charge when they have no funding. This support is particularly important to help fellows and junior faculty get started in research. This support is also important for more seasoned researchers who have innovative ideas and need support to acquire pilot data. Although every investigator is treated equally, productivity is tracked carefully and future investments in that investigator are determined by the yield on past projects. Free consultation to productive investigators can be viewed as an investment that pays off in prestige for all in the near term and in a relationship that may generate funded research in the long term. For investigators outside the Department of Pediatrics, we bill fee-for-service.

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Developing Synergy 

To maximize efficiency, we coordinate many clinical research positions in the department. For example, investigators often share research associates, and the division monitors the allocation of their time. When there is an immediate need for a research associate, we can quickly identify and place an appropriately trained staff member. Central sharing of personnel in the department saves costs at the local and institutional level.

Educational programs on basic and clinical research methods can also expand the division. For instance, we have established weekly “Pediatric Clinical Research Forums” that are intended to initiate thought-provoking discussions on methodologies among investigators and are videoconferenced to remote sites. Members from all divisions in the department, other university departments, and interested community groups are invited to attend these interactive forums. As a result, new collaborations are formed, ideas are shared across disciplinary lines, and the general level of research expertise is improved.

As with many other experiences, “community is everything”; accomplishments from individuals performing in isolation are far fewer than those arising from a supportive, synergistic environment. There are no substitutes for “corridor conferences!” We allow junior faculty/fellows from pediatric subspecialty divisions to have a “primary home” in the division. This arrangement provides the investigator with 2 mentors: a clinical mentor (affiliated with the subspecialty division) who helps formulate research questions, and a research mentor who helps design the study, develop the necessary data management capabilities, and plan the statistical analysis. Immersing junior faculty/fellows in a clinical research “neighborhood” in this way intensifies their research experience, experience that often makes its way back to the primary division, further stimulating interest in research.

For some clinicians, providing a strong system for clinical research is not sufficient. We have been able to team busy clinicians with epidemiologists who share similar research interests. Such teams are cost-effective because the clinician contributes the medical expertise and access to patients and the epidemiologist contributes the technical aspects of planning and conducting the study. Both professionals become more successful and productive than either could have alone.

Nationwide, institutions have realized that funding from the NIH and other sources has been increasingly difficult to obtain. We regularly match faculty interests to new research opportunities (all data-based) and notify faculty of these opportunities electronically. We coordinate meetings to encourage development of promising grant applications. We facilitate the institutional review board process, develop budgets, manage post-award contracts, have a shared clinical component for evaluating study participants and for maintaining a biological specimen repository, and employ professionals in medical editing.

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Integrating With Other Programs 

A pediatric-specific research division ensures that research in child health will be the overriding priority. However, initiatives, including the Clinical and Translational Science Awards (CTSAs) and NIH-sponsored pediatric networks/consortia, have begun to increase the efficiency and speed of clinical and translational research. These initiatives offer new platforms for multi-disciplinary collaboration and may be a particularly good resource for pediatric departments and research centers wishing to expand their research programs, provided the challenges of integrating pediatrics into the CTSAs can be overcome. An existing local child health research infrastructure will help establish, maintain, and capitalize on membership in the NIH CTSA network, participation in other NIH-sponsored pediatric networks and consortia, and child health research conducted independently of these mechanisms.

The CTSA Pediatric Oversight Committee Report from March, 2007 identified some unique challenges to be met in child health research. These challenges include the need: to collect normative data on children as they grow, to speed the drug development and approval process, to study rare diseases, to address the logistics of caring for children and families, and to resolve issues related to consent, assent, and institutional review board approval. The committee also expressed concerns about the low number of investigators entering the field of pediatric research, decreases in research funding, and the increasing costs of research nurses. The committee believes that the CTSA could encourage pediatric research by developing “common research agendas, joint protocols, normative data, biobanks, and extend existing pediatric research networks and establish new ones across CTSA sites.”

These great and often unique needs have stimulated considerable efforts to preserve independent funding and infrastructure support for pediatric clinical research. Considerable advocacy by the child health research community has occurred for a second principal investigator, focused on pediatrics, to be appointed within a single CTSA, and who would be given a separate budget and infrastructure for pediatric research to assure the institutional financial, logistic, and research independence of pediatric clinical research centers. At a time when the national CTSA trend is to fund larger university-wide research initiatives, this new independence initiative was signed into law on Jan 15, 2007 as PL 109-687, supporting the need to address child health research issues in specialized ways.

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Conclusion 

From the ground up and with strong institutional support, we have developed a Pediatric Clinical Research Division. The Department of Pediatrics is the leader in our medical school for extramural funding. We challenge other pediatric institutions, regardless of size and wealth, to invest in an infrastructure for clinical research on child health. This investment, as we have found, has great payoffs for the researcher, the institution, and, most importantly, for advancing our knowledge of children’s health.