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Estimating clinical research project duration from idea to publication
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  1. Dmitry Tumin1,
  2. Kori L Brewer2,
  3. Doyle M Cummings3,
  4. Keith L Keene4,
  5. Kendall M Campbell5
  1. 1Division of Academic Affairs and Department of Pediatrics, Brody School of Medicine at East Carolina University, Greenville, North Carolina, USA
  2. 2Department of Emergency Medicine and Department of Physiology, Brody School of Medicine at East Carolina University, Greenville, North Carolina, USA
  3. 3Department of Family Medicine and Department of Public Health, Brody School of Medicine at East Carolina University, Greenville, North Carolina, USA
  4. 4Department of Biology and Center for Health Disparities, East Carolina University, Greenville, North Carolina, USA
  5. 5Division of Academic Affairs and Research Group for Underrepresented Minorities in Academic Medicine, Brody School of Medicine at East Carolina University, Greenville, North Carolina, USA
  1. Correspondence to Dr Dmitry Tumin, Brody School of Medicine at East Carolina University, Greenville, NC 27834, USA; tumind18{at}ecu.edu

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The scientific response to the COVID-19 pandemic has elicited commentaries on the quickening of biomedical research,1–3 contrasting with literature on prolonged time to publication for clinical research projects.4–6 We investigated research project duration for three clinical departments (emergency medicine, family medicine, and pediatrics) with centralized research leadership in a community-based US medical school. Following institutional review board (IRB) approval, we identified original research reports published or accepted in academic year 2019–2020, originating at our institution, and involving faculty from these departments. Of 39 eligible publications, we reconstructed study timelines (table 1) for 17 publications based on departmental records, and 10 publications based on a survey of corresponding authors.

Table 1

Data points on project stages, by project type

The median overall project duration was 18 months (IQR 10–26). Median durations of specific phases were 2 months for project development (IQR 1–4), 6 months for execution (IQR 1–18), 2 months for writing (IQR 1–4), and 4 months for publication (IQR 2–5). Durations are compared by project type and stage in table 2. On multivariable Cox regression analysis, time to publication was prolonged for prospective versus retrospective projects (HR of publication 0.14, 95% CI 0.02 to 0.83, p=0.030) and funded versus unfunded projects (HR 0.13, 95% CI 0.02 to 0.80, p=0.027). Twelve articles were accepted or published during the COVID-19 pandemic (April–June 2020). Median project duration was longer compared with pre-COVID publications in our sample (20, IQR 19–25 months, vs 13, IQR 9–40 months), but this difference did not reach statistical significance (rank-sum p=0.271).

Table 2

Project duration (in months) by project characteristics (N=27)

Qualitatively, centralized research support programs have been described as ‘expediting’ clinical research7 by addressing limitations of time, funding, and expertise among investigators.8–10 Short-term evaluations of such programs (<2 years) have focused on activities which can be completed in a few months, such as IRB protocol or grant submission8; or manuscript submission, but not necessarily publication.10 Indeed, within this time frame, many projects receiving central support may not reach publication. We propose that tracking project duration from conception to publication, in addition to discrete steps such as conference presentation or grant submission, can help identify opportunities for improving the research process for investigators.

Our data also have important implications for faculty career development and mentorship. In light of the typical research project duration, pursuing projects concurrently rather than sequentially is important for building a strong file for promotion and tenure. While faculty with extramural funding ultimately tend to achieve higher academic productivity,11 12 an important finding was that grant-funded research took significantly longer from conception to publication than unfunded research. Delays on grant-funded projects may be addressed by optimizing institutional grant-related processes and developing a diverse portfolio of funded and unfunded research. Lastly, we present an early comparison of project duration for publications accepted before and during the early months of the COVID-19 pandemic. Considering the long life cycle of a typical project, the impact of the pandemic on project duration and publication is likely to continue accumulating in the months ahead and may pose serious career challenges for active scientists.

References

Footnotes

  • Contributors All authors participated in study conceptualization and design. DT, KB and DC participated in data collection. DT performed data analysis and drafted the manuscript. KB, DC, KK and KC interpreted the results and critically revised the manuscript. All authors approved the final version to be submitted.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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