Clinical trials site recruitment optimisation: Guidance from Clinical Trials: Impact and Quality

Background/Aims: Participants are integral to the success of any clinical research study, yet participant recruitment into clinical trials poses ongoing and complex challenges. It is widely accepted and recognised that clinical trial sites often find it difficult to meet recruitment goals, both in terms of accrual targets and timelines. This can impact the validity of trials or cause major delays for research. There are very few frameworks available to clinical trial sites to improve recruitment. The GREET project (Guidance to Recruitment: Examining Experiences at clinical Trial sites) sought to identify barriers to recruitment and produce formal guidance to optimise recruitment outcomes. Methods: Clinical Trials: Impact and Quality, a collaborative of sector stakeholders, convened a project team with comprehensive knowledge of the Australian clinical trials sector to undertake the GREET project. The project scope included exploration of recruitment issues at a site level across all phases of clinical trials and all types of trial sites. The scope excluded upstream issues such as protocol design and general public clinical trial awareness, participant retention and elements of recruitment outside a site’s capacity to directly influence or control. The project team’s extensive knowledge and experience conducting clinical trials in Australia was used to collaboratively identify a list of 24 key barriers and 12 enablers to site recruitment which formed the basis of the project. Key stakeholder groups were surveyed to challenge project team assumptions. A national and international environmental scan and literature review was conducted to identify best-practice recruitment solutions. Results: A total of 343 people responded to a survey sent to sites, sponsors, and contract research organisations, and 162 people responded to a survey sent to consumers via consumer networks. The key barriers and enablers initially identified by the project team aligned with the key outcomes of the surveys, which in turn assisted in the development of best-practice recommendations in the form of a Clinical Trial Site Recruitment Guide. Recommendations were grouped into four key themes; conducting accurate study feasibility; proactive planning during start-up; selecting optimal recruitment methods; and participant involvement. Early intervention was identified as a key facilitator in maximising improved recruitment outcomes. The GREET Clinical Trial Site Recruitment Guide is publicly accessible on the Clinical Trials: Impact and Quality website. Conclusion: Participant recruitment challenges experienced at a site level are widespread and varied, and there is no universal recruitment solution. However, this project identified that there are interventions and assessments that can be proactively implemented and selectively applied to facilitate improved recruitment outcomes.

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AB1360-HPR A MODEL TO IMPROVE MINORITY PATIENT RECRUITMENT IN LUPUS CLINICAL TRIALS - THE AMERICAN COLLEGE OF RHEUMATOLOGY MIMICT PROJECT EXPERIENCE

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6541 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1967.2-1967

Author(s):

S. Sheikh ◽

N. Wanty ◽

S. Mccalla ◽

A. Santana ◽

S. Saxena Beem ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Women’S Health ◽

Women's Health ◽

Lupus Erythematosus ◽

Self Efficacy ◽

Trial Site ◽

American College Of Rheumatology ◽

Clinical Trial Site ◽

The Us

Background:In the US, African Americans and Latinos are underrepresented in lupus clinical trials (LCTs),1despite experiencing the greatest lupus disease burden.2,3Low participation in LCTs results in inadequate data on treatment effectiveness for minority patients, and fewer opportunities for better care and treatment options.1Only one percent of minority patients are referred to clinical trials each year.4Provider barriers to making referrals include limited time and unfamiliarity with lupus and LCT opportunities.4Using US fedral grant funds, the American College of Rheumatology (ACR) developed MIMICT, a two-part model with associated materials to address provider-side LCT referral barriers. The materials include a toolkit for clinical trial sites and an educational toolkit for providers.Objectives:Our objectives are to:•Describe the US LCTs disparities.•Discuss the research methodology to evaluate the two-part MIMICT model.•Assess the feasibility of the model to increase minority involvement in clinical trials.Methods:We designed two studies to evaluate the MIMICT model.The first study used an online, pretest/posttest, two-group evaluation approach to assess the extent to which the educational toolkit increased providers‘ knowledge, attitudes, self-efficacy, and behavioral intentions to refer minority patients to clinical trial. We conducted the study in 2018 with primary care providers (PCPs) and again in 2019/2020 with speciality providers. The second study used a longitudinal, mised methods, case-study approach to explore the real-world use of the toolkits with clinical trial site teams at two university medical centers.Results:In the first study,among MIMCT-exposed PCPs, mean scores indicated statistical significance at p≤0.001 with more knowledge about referring [55.84 (sd=23.51) vs 41.76 (sd=19.98)], more self-efficacy to refer [55.00 (sd=37.22) vs. 37.99 (sd=34.42)], and more intentions to refer [61.36 (43.85) vs. 33.41 (41.16)] African American patients to LCTs among the treatment group than the control group, respectively. This presentation will discuss additional data comparing the study in 2018 and the study in 2019/2020 and look comparatively at outcomes across provider type.In the second study, we found that the driver for successful engagemetn of providers and their subsequent use of the educational toolkit was the development of a trusting relationship between the clinical trial site teams and providers in the community. The development of trust took repeated and varied modes of contact, which we will discuss in-depth.Conclusion:The MIMICT educational toolkit increase knowledge, self-efficacy, and intentions to refer lupus patients to LCTs. However, building trust between LCT sites and local providers takes time and repeated outreach, but the potential benefits to medicine and minority health are substantial.References:[1]The Society for Women’s Health Research. (2011). Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. Washington, DC: Food and Drug Administration, Office of Women’s Health.[2]Falasinnu, T., Chaichian, Y., Bass, M. B., & Simard, J. F. (2018). The representation of gender and race/ethnic groups in randomized clinical trials of individuals with sytemic lupus erythematosus.Current Rheumatology Reports, 20(4).[3]Pons-Estel, G. J., Alarcon, G. S., Scofield, L., Reinlib, L., & Cooper, G. S. (2010). Understanding the epidemiological progression of systemic lupus erythematosus.Seminars in Arthritis and Rheumatism, 39(4).[4]Korieth, K. (2016). Engaging healthcare providers as research facilitators.The CenterWatch Monthly, 23,1-5.Disclosure of Interests:None declared

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Phase I (first-in-man) prophylactic vaccine′s clinical trials: Selecting a clinical trial site

Perspectives in Clinical Research ◽

10.4103/2229-3485.154001 ◽

2015 ◽

Vol 6 (2) ◽

pp. 77

Author(s):

Shantanu Mehta ◽

Kavita Singh ◽

Vishal Goyal

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Phase I ◽

Prophylactic Vaccine ◽

Trial Site ◽

Clinical Trial Site

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How a Psychopharmacology Clinical Trial Site in the Seattle Area Managed Clinical Trials and Patient Care During the COVID-19 Pandemic

American Journal of Geriatric Psychiatry ◽

10.1016/j.jagp.2020.06.012 ◽

2020 ◽

Vol 28 (9) ◽

pp. 999-1003

Author(s):

Shirin Schilling ◽

Sinthuja Mohanarajah ◽

Abraham Mengstu ◽

Arif Khan ◽

Walter A. Brown

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Patient Care ◽

Trial Site ◽

Clinical Trial Site

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Handbook of Basic Fundamentals and Regulations of Clinical Trial Site Management

10.22271/ed.book.1178 ◽

2021 ◽

Keyword(s):

Clinical Trial ◽

Site Management ◽

Trial Site ◽

Clinical Trial Site

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Using Social Media to Increase the Recruitment of Clinical Research Participants

Encyclopedia of Information Science and Technology, Fourth Edition ◽

10.4018/978-1-5225-2255-3.ch624 ◽

2018 ◽

pp. 7181-7189

Author(s):

Saliha Akhtar

Keyword(s):

Clinical Trial ◽

Social Media ◽

Clinical Trials ◽

Clinical Research ◽

Recruitment Strategies ◽

Primary Role ◽

Trial Recruitment ◽

Recruitment Methods ◽

Pros And Cons ◽

Clinical Trial Recruitment

Research has shown that clinical research continues to have difficulty recruiting participants. This problem is expected to increase as the number of clinical trials increases and as there continues to be more focus on complex diseases and treatments. Researchers have typically relied on traditional recruitment methods to recruit participants, which revolve around the physicians and their support staff having the primary role to locate and recruit these participants. However, with individuals using online platforms such as social media to retrieve information, this creates an opportunity for research site personnel to use it as a way to relay information on clinical trial opportunities. Studies that have used social media as a way to recruit participants are discussed. Furthermore, pros and cons of social media for recruitment, along with recommendations that future researchers should consider when deciding whether to implement this type of strategy in their clinical trials will be shared. In general, clinical trial recruitment strategies need to shift to an approach that is not only more targeted, but also has a larger reach. By evaluating the success of studies that have used social recruitment strategies so far, it is evident that future researchers can also achieve recruitment success through social media. Moreover, social media could be a promising new avenue for clinical trial recruitment that allows for a more positive experience for both investigative site personnel and potential participants.

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Multi-Centre Clinical Trial Site Monitoring Visits Focus on Data Accuracy and Miss Important Opportunities To Improve Trial Conduct: Results of a Survey of Experienced Research Coordinators (RCs).

10.1164/ajrccm-conference.2009.179.1_meetingabstracts.a1571 ◽

2009 ◽

Author(s):

EA Sweetman ◽

GS Doig ◽

F Simpson ◽

PT Heighes

Keyword(s):

Clinical Trial ◽

Data Accuracy ◽

Trial Site ◽

Trial Conduct ◽

Site Monitoring ◽

Clinical Trial Site

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Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points

Circulation Heart Failure ◽

10.1161/circheartfailure.116.002986 ◽

2016 ◽

Vol 9 (9) ◽

Cited By ~ 6

Author(s):

Stephen J. Greene ◽

Adrian F. Hernandez ◽

Jie-Lena Sun ◽

Marco Metra ◽

Javed Butler ◽

...

Keyword(s):

Clinical Trial ◽

Patient Characteristics ◽

End Points ◽

Trial Site ◽

Clinical Trial Site

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Distribution and geographic accessibility of prostate cancer clinical trials in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.4_suppl.59 ◽

2014 ◽

Vol 32 (4_suppl) ◽

pp. 59-59 ◽

Cited By ~ 2

Author(s):

Matt D. Galsky ◽

Asma Latif ◽

Kristian D. Stensland ◽

Erin L. Moshier ◽

Russell McBride ◽

...

Keyword(s):

Prostate Cancer ◽

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Geographic Distribution ◽

The United States ◽

First Line ◽

Trial Site ◽

Lorenz Curves ◽

Number Of Patients

59 Background: An extremely small proportion of patients with cancer in the United States (US) enroll in clinical trials. While several barriers to trial accrual have been described, the geographic distribution and accessibility of clinical trial sites has not been comprehensively explored. Methods: ClinicalTrials.gov was queried to identify all active US clinical trials exploring first-line therapies for metastatic prostate cancer (PCa) on 9/16/2012. We evaluated the geographic distribution of trial sites and determined the relationship between the number of sites and the number of patients with advanced PCa per county and evaluated heterogeneity using Lorenz curves. We also estimated the minimum driving distance required to access a clinical trial site from each ZIP code in the continguous US; a distance >30 miles was defined as high travel burden consistent with prior studies. Results: We identified 958 sites associated with 42 PCa clinical trials (Table). The geographic distribution of clinical trial sites was very inhomogeneous with several states having only 1-2 trial sites. Among 3185 US counties, 2,669 (83.8%) had no clinical trials available for first-line treatment of metastatic PCa. Counties with larger populations of patients with advanced PCa had significantly higher numbers of clinical trial sites. For every 100 additional patients with advanced PCa per county, the number of available trial sites increased by 21.0% (95% CI: 16.5-25.7%). However, Lorenz curves indicated a high degree of inequality in trial accessibility (Gini index 0.71). Approximately 31% of the US population resided >30 miles from a PCa trial site. Conclusions: Clinical trials sites are poorly accessible, geographically, to a large subset of US PCa patients, a finding that likely contributes to dismal accrual. Innovative solutions are required to address geographic barriers to access. [Table: see text]

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