The Unseen Cost of Clinical Research in Pediatric Urology: An Analysis of Two Retrospective Studies
Brandon Tewksbury, MD1, Vishnu Sridhar, BS2, Rocio Goodman, BA2, Steven Wright, BA3, Robert J. Batt, PhD4, Shannon Cannon, MD2, Walid Farhat, MD2, Vinaya Bhatia, MD2.
1University of Texas Health Science Center at San Antonio, San Antonio, TX, USA, 2Division of Pediatric Urology, Department of Urology, University of Wisconsin-Madison, Madison, WI, USA, 3University of Wisconsin - School of Medicine and Public Health, Madison, WI, USA, 4Wisconsin School of Business, University of Wisconsin-Madison, Madison, WI, USA.
BACKGROUND: Clinical research is pivotal for improving clinical practice and ultimately patient care. We sought to analyze the duration and estimate the cost of conducting retrospective research studies in pediatric urology.
METHODS: Two retrospective studies that were successfully presented or published respectively were used to evaluate time and effort put into research design and submission. We conducted semi-structured interviews as well as reviewed email communications related to these studies. The interviews included questions regarding what each member considered to be major steps of research, who was responsible for each step, and the expected durations of each step. Possible research steps began with idea conception and ended with manuscript publication. Qualitative analysis was used to generate a conceptual framework, which was revised over two subsequent interview cycles. Using our IRB database and email records, we applied our conceptual framework to determine the start date and end date of each process step. Next, we used step duration, standardized salary grades, and a Responsibility Attribution (RACI) Matrix to estimate the labor costs for the “responsible” party for two recent retrospective cohort studies. Additional assumptions for our cost model included that 1 day equated to 1 hour of active work on a project and each process stage occurred serially.
RESULTS: From our interviews, the process steps included: Ideation, Approvals, Resourcing, Data Collection, Abstract, and Publication. Project A took 391 calendar days to complete an abstract acceptance (expected 214 days), and Project B took 1243 calendar days to complete manuscript acceptance (expected 301 days). Both Project A and Project B accrued a higher estimated cost than expected: Abstract Expected ~$36k, Abstract Actual ~$55k (53% greater), Manuscript Expected ~$60k, Manuscript Actual ~$210k (250% greater) (see Table 1). Data Collection (145-532 days) and Manuscript Publication (432 days) were the rate-limiting steps.
CONCLUSIONS: In its current state, clinical research in pediatric urology is costly and time-consuming, and inefficiencies in the process of Data Collection and Manuscript Publication could affect the timely dissemination of findings in our field. We recommend particular focus on working with experts in resourcing for data collection and to consider alternative workflows with research staff to efficiently assemble manuscripts to improve our research process.
Table 1: Expectation vs. Reality - Process Step Duration and Estimated Cost of Labor
| Process Stage (Conceptual Framework) | Expectation | Project A | Project B |
| Ideation | 44 | 22 | 132 |
| Approvals | 38 | 8 | 46 |
| Resourcing | 43 | 90 | 45 |
| Data Collection | 23 | 145 | 532 |
| Abstract | 66 | 126 | 56 |
| Publication | 87 | N/A | 432 |
| Total | 301 | 391 | 1243 |
| Estimated Cost | $59,818 | $55,757 | $210,578 |
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