P2D257: Publish or Perish - The Unseen Cost of Doing Clinical Research

Purpose/Objectives: Clinical research and publication are pivotal for improving clinical practice, necessitating study of the efficiency of current research processes. We sought to analyze the duration and cost of conducting clinical research studies.

Design/Methods: One investigator conducted semi-structured interviews with our team consisting of physicians and research analysts/coordinators. Questions included what each member considered to be major steps of research, who was responsible for each step, and the expected durations of steps. 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 duration and a Responsibility Attribution (RACI) Matrix to estimate the labor costs for the “responsible” party for two recent retrospective cohort studies. RACI assigns who is “responsible” for a task, followed by those accountable, consulted, and informed. 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 overarching themes of our process steps included: Ideation, Approvals, Resourcing, Data Collection, Abstract, and Publication. Our two sample projects included Project A, which went from Ideation to Abstract Presentation, and Project B, which went from Ideation to Manuscript Publication. Project A took 391 calendar days to complete an abstract acceptance, and Project B took 1243 calendar days to complete manuscript acceptance. Both Project A and Project B took longer than expected, and therefore accrued a higher estimated cost than expected (Table 1), with Data Collection (145-532 days) and Manuscript Publication (432 days) being the rate-limiting steps.

Conclusion/Discussion: In its current state, clinical research is costly and inefficient. Data Collection and Manuscript Publication are significant, rate-limiting steps for dissemination. We recommend particular focus on working with experts in data collection and Electronic Medical Record experts to streamline the data collection process, and to consider alternative workflows with research staff to efficiently assemble manuscripts.