Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

“…Delays in regulatory approvals in international trials is not unique to PARITY and has been encountered by several previous RCTs [21,22]. Clinical research coordinators and research assistants are considered integral to running and completing a successful clinical trial [34][35][36]. Survey based research has determined that the majority of Principal Investigators believe that clinical research personnel are able to improve recruitment [37].…”

Section: Discussionmentioning

confidence: 99%

Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients

Gazendam

Bozzo

Schneider

et al. 2020

Preprint

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Introduction: The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) randomized controlled trial (RCT) was the first study to prospectively enroll and randomize orthopaedic oncology patients in multiple centers internationally. The objective of this study was to describe recruitment patterns, examine the differences in enrollment across different PARITY sites, and to identify variables associated with differing levels of recruitment.Methods: Data from this study was obtained from the PARITY trial Methods Center and records of correspondence between the Methods Center and recruiting sites. We performed descriptive statistics to report the recruitment patterns over time. We compared recruitment, time to set up, and time to enroll the first patient between North American and international sites, private and public health care models, and the presence or absence of research personnel. Two-tailed non-paired t-tests were performed to test average monthly recruitment rates between groups. Results: A total of 602 patients from 36 North American and 12 international sites were recruited from 2013 to 2019. Average monthly enrollment increased each year of the study. North American sites were able to start up significantly faster than international sites (19.5 vs. 27.0 months p=0.04). However, international sites had a significantly higher recruitment rate once active (0.2 participants/month vs. 0.59 participants/month, p=0.023). Sites with research personnel were able to reach ‘enrolment ready’ status significantly faster than sites without research personnel (19.3 vs. 30.3 months, p=0.032), but there was no difference in recruitment once active (0.28 participants/month vs. 0.2 participants/month). Publicly funded sites were to recruit significantly more patients compared to private institutions (0.4/month vs. 0.17/month, p=0.03).Conclusions: As a collaborative group, the PARITY investigators increased the pace of recruitment throughout the trial, likely by increasing the number of active sites. The longer time to start-up at international sites may be due to the complex governing regulations of pharmaceutical trials. Nevertheless, international sites should be considered essential as they recruited significantly more patients per month once active. The absence of research support personnel may lead to delays in time to start up. The results of the current study will provide guidance for choosing which sites to recruit for participation in future collaborative clinical trials in orthopaedic oncology and other surgical specialties.

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“…While this literature has provided valuable information on the workforce delivering health research, it has a number of limitations. Much is comprised of commentaries rather than empirical studies (eg Bird & Kirshbaum, 2005;Gibbs and Lowton, 2012;Gordon, 2008;Hastings, Fisher & McCabe, 2012;Ledger, Pulfrey, & Luke, 2008;Stephens-Lloyd, 2004) and most of the empirical studies have focused on those who work on clinical trials (eg Spilsbury et al, 2008;Wilkes et al, 2012;Yanagawa, Akaishi, Miyamoto et al, 2008) in a hospital setting (eg Hill & MacArthur, 2006;Rickard et al, 2011;Roberts, Eastwood, Raunow, et al, 2011) or on research within a single specialist area (eg Catania, Poire, Bernardi et al 2012;Eastwood et al, 2012;Nagel, Gender, & Bonner 2010;Rickard et al, 2006;Roberts et al, 2011). Translational and applied health research, however, encompasses a much wider range of studies than clinical trials and studies may be undertaken in settings other than hospitals.…”

Section: Literature Reviewmentioning

confidence: 99%

The workforce delivering translational and applied health research: A cross sectional survey of their characteristics, studies and responsibilities

Boulton

Hopewell

2017

Collegian

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Background: Translational and applied health research, and the workforce needed to deliver it, have grown substantially in the last 10 years and this growth is likely to continue. However, there are few good empirical studies of the workforce and only limited evidence on which to base future policy and practice. Aim: To provide a better understanding of the workforce that delivers translational and applied health research by exploring who delivers studies, what types of studies are delivered and what delivering them entails and whether this varies across employment contexts. Methods: A link to an on-line questionnaire was sent to 280 non-medical researchers in England funded by National Institute for Health Research to deliver translational and applied health research; 168 (60%) responded. Responses were analysed quantitatively. Findings: Participants were from 11 occupational groups, with nurses (77%) the most common. Most (82%) had worked on clinical trials and almost as many (73%) on observational studies. A fifth had conducted studies outside hospital settings. Participants recruited from Community sites more often reported taking a medical history (p=0.022) and carrying out initial assessments (p=0.028) and less often reported managing other staff (p=0.036). Those recruited through the University Hospital more often reported contributing 2 to development of new studies (p=.000); to research governance (p =0.001) and protocols (p=0.000); and to writing publications (p=0.005). Discussion: There is greater diversity in the workforce than previously identified, more variation in types of studies delivered and a wider range of settings. Responsibilities vary across employment contexts. Conclusions: This diversity needs to be acknowledged in educational, training and career planning to sustain capacity for delivering translational and applied health research in the future.

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Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

Cited by 13 publications

References 10 publications

A worldwide investigation of critical care research coordinators’ self‐reported role and professional development priorities: the winner survey

A worldwide investigation of critical care research coordinators’ self‐reported role and professional development priorities: the winner survey

Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients

The workforce delivering translational and applied health research: A cross sectional survey of their characteristics, studies and responsibilities

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