Starting and Running a Clinical Trial as a Hospitalist-Slides

Pdf Summary

This presentation by Drs. Karthik J Kota and James D Prister from Rutgers Robert Wood Johnson Medical School addresses the challenges and strategies for successful recruitment in investigator-initiated academic clinical trials, particularly when no paid research coordinator is available. Using two trials conducted at the same site—the DOSE trial (determining optimal corticosteroid dosing in COPD exacerbations) and the CODE trial (assessing the effect of terminology on patients’ code status decisions)—the authors highlight common recruitment hurdles and practical approaches.<br /><br />Key points include that a majority of residents recruited few patients, that principal investigators must often do most of the recruiting themselves, and that recruitment is labor-intensive, requiring sustained effort and flexibility. Both trials underscored the importance of clear communication, simplifying study demands (“Ask Little”), and leveraging existing healthcare infrastructure to reach participants without additional burden.<br /><br />The presentation reviews literature showing that 85% of clinical trials fail to recruit sufficient participants, with minority and older adult populations notably underrepresented. Barriers include not being asked to participate, stringent exclusion criteria, and systemic issues, rather than mistrust or racial concordance alone. Recruiting strategies suggested include directly asking all eligible participants, partnering with volunteers or students for recruitment support, utilizing patient registries of engaged subjects, and collaborating with colleagues and community partners.<br /><br />Reducing barriers for older and minority adults involves practical measures like not excluding older adults unnecessarily, addressing transportation issues, emphasizing trust and clear benefit, and offering compensation that respects participants’ time without coercion. Trial design should focus on feasible, answerable questions, selecting publishable outcomes, and minimizing participant burden.<br /><br />The authors emphasize that successful recruitment depends heavily on the PI’s interest and investment. Pilot data build credibility for funding, but unpaid studies require significant “sweat equity.” Ultimately, trial success rests on thoughtful design, persistent engagement, and recognizing recruitment as central to scientific progress. The presentation includes references and practical take-home messages encouraging investigators to self-manage and sustain recruitment efforts creatively and ethically.

Meta Tag

Concept Investigator-Initiated Clinical Trial

Concept Recruitment

Concept Eligibility Criteria

Concept Exclusion Criteria

Concept Recruitment Barrier

Keywords

investigator-initiated clinical trials

recruitment challenges

clinical trial recruitment strategies

DOSE trial

CODE trial

minority and older adult recruitment

participant barriers

principal investigator role

clinical trial design

ethical recruitment practices

Investigator-Initiated Clinical Trial

Recruitment

Eligibility Criteria

Exclusion Criteria

Recruitment Barrier