key: cord-0714911-al22njco
authors: Tumin, Dmitry; Brewer, Kori L; Cummings, Doyle M; Keene, Keith L; Campbell, Kendall M
title: Estimating clinical research project duration from idea to publication
date: 2021-05-12
journal: J Investig Med
DOI: 10.1136/jim-2021-001915
sha: 16d0132c0d713cb5509c7aa9e6c94c116a7824d2
doc_id: 714911
cord_uid: al22njco

nan

The scientific response to the COVID-19 pandemic has elicited commentaries on the quickening of biomedical research, [1] [2] [3] contrasting with literature on prolonged time to publication for clinical research projects. [4] [5] [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.

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).

Qualitatively, centralized research support programs have been described as 'expediting' clinical research 7 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 submission 8 ; or manuscript submission, but not necessarily publication. 10 Indeed, within this time frame, many projects receiving central support may not Letter to the editor 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 grantfunded research took significantly longer from conception to publication than unfunded research. Delays on grantfunded 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.

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.

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.

This article is made freely available for use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

Dmitry Tumin http:// orcid. org/ 0000-0002-9180-7656

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Table 2 Project duration (in months) by project characteristics (N=27) Characteristic Median (IQR) project duration (months) 5, 24) <1

Kruskal-Wallis test. †Statistically significant difference according to need for regulatory approval (p<0.05) on rank-sum test. ‡Statistically significant difference according to receipt of external funding (p<0.05) on rank-sum test