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BackgroundLimited regulatory guidance surrounding the use of social media channels for participant recruitment is an interdisciplinary challenge. Establishing stakeholder-informed procedures is essential for ethical and effective use of social media for participant recruitment. ObjectiveThis study aims to provide replicable procedures for developing and implementing guidelines for using social media to recruit participants in research studies. MethodsSocial media use cases at the university were used to identify institutional stakeholders for the initiative. After establishing workflow procedures, a scoping review of web-based materials about recruitment and research on the internet and social media from 19 peer institutions and 2 federal agencies was conducted to inform the structure of the policies and procedures. End users (investigators and study coordinators; N=14) also provided feedback on the policies and procedures and implementation. ResultsRepresentatives (n=7) from 5 institutional offices and 15 subject-matter experts from 5 areas were identified as stakeholders in the development of policies and procedures. Peers with web-based materials (n=16) identified in the scoping review revealed 4 themes that served as a basis for developing our policies and procedures. End user feedback further informed the policies and procedures and implementation. A centrally managed social media account for communicating with participants and hosting advertising campaigns on social media was also established and, when combined with the policies and procedures, resulted in 39 advertising campaigns, and 2846 participants were enrolled in health and clinical research studies. ConclusionsOur policies and procedures allow research teams to harness the potential of social media to increase study recruitment and participation; the transparent, stakeholder-informed process can be replicated by institutional administrators to establish policies and procedures that meet the interests and needs of their research community.

Daily intravenous arsenic trioxide administered with all-trans retinoid acid, the standard-of-care for acute promyelocytic leukemia, is costly and challenging to administer. ORH-2014 is a novel, oral arsenic trioxide formulation, consisting of micron-size drug particles with rapid dissolution and high bioavailability. We conducted a multicenter phase 1 dose-escalating study in patients with advanced hematologic malignancies. Twelve patients received ORH-2014 at 5 mg (n=3), 10 mg (n=6), or 15 mg (n=3) orally once a day (fasted state). Objectives were to assess the safety, tolerability and pharmacokinetics of ORH-2014 to support a dose recommendation for future trials. The median age of the patients was 77 years (range: 45-81) and they had received a median of two (range: 1-5) prior therapies. There were no dose limiting toxicities and no drug-related severe adverse events, except one grade III QT prolongation occurring beyond the dose limiting toxicity assessment period and resolving after treatment interruption. ORH-2014 steady-state plasma concentration was reached on day 15. ORH-2014, 15 mg Cmax was comparable to the calculated approved dose of intravenous arsenic trioxide (mean [% coefficient of variation]: 114 [21%] vs. 124 [60%] ng/mL) and area under the curve from 0 to 24 hours was 2,140 (36%) versus 1,302 (30%) h*ng/mL. These results indicate that ORH-2014 at 15 mg is safe, bioavailable, and provides the required arsenic exposure compared to intravenous arsenic trioxide at the approved dose (0.15 mg/kg); this ORH-2014 dose is recommended for future trials. (NCT03048344; www.clin-icaltrials.gov).

Introduction: Created in 1995, The University of Missouri School of Medicine’s Rural Track Pipeline Program was designed to address physician shortages in rural Missouri through medical student participation in a series of clinical and non-clinical programs over the course of their medical training to influence graduates to choose rural practice.Methods: To increase the likelihood of students choosing rural practice, a 46-week longitudinal integrated clerkship (LIC) was implemented at one of nine existing rural training sites. Over the course of the academic year, quantitative and qualitative data was collected to evaluate effectiveness of the curriculum and for quality improvement purposes.Results: Data collection is in progress and includes student evaluation of the clerkship, faculty evaluations of students, student evaluations of faculty, student aggregate clerkship performance, and qualitative data from student and faculty debrief sessions.Discussion: Based on data collected, changes are being made to the curriculum for the following academic year to enhance the student experience. The LIC will also be offered at an additional rural training site beginning in June of 2022, and then expanded to a third site in June of 2023. As each LIC is unique, our hope is our experience and lessons learned will help others in developing a LIC or improving an existing LIC.