Clinical Trial Recruitment Research Articles

A cross-sectional survey of clinical trials knowledge, participation, and perspectives in an underserved community of Washington, DC.

The inclusion of participants from underrepresented and underserved groups is lagging in dermatology clinical trials. Through dissemination of a pilot survey at a community skin health fair, knowledge, participation, and perspectives of clinical trials were evaluated in an urban, medically underserved community in Washington, DC. Clinical trial-related questions were derived from the Health Information National Trends Survey 5 Cycle 4. This cross-sectional survey analyzed responses from 39/55 attendees (71% response rate). Most respondents were female (23/37 [62.2%]), between the ages of 25 and 54 (19/38, [50.0%]), and self-identified as non-white (35/39 [89.7%]) with a majority self-identifying as Black (16/31 [41%]). Most respondents self-reported knowing "little" to "nothing" about clinical trials (26/35 [74.3%]), and even more were unaware of the federal resource clinicaltrials.gov (30/37 [81.1%]). Few respondents discussed clinical trials as a treatment option with their healthcare provider (8/35 [22.9%]), yet having a discussion was significantly correlated with clinical trial participation (p = 0.0302). Self-reported level of knowledge was not significantly associated with participation in a clinical trial (p = 0.3035). Healthcare providers were the preferred first source of clinical trial information, followed by an internet search. Respondents rarely cited mistrust or skepticism as a barrier to participation (2/34 [5.9%]). Subjective positive healthcare experiences were significantly correlated to positive expectations with clinical trial participation (p = 0.0242). The findings of this study suggest the essential role healthcare providers, including dermatologists, play in clinical trial education and recruitment of underrepresented populations, and that patient mistrust may be present but is a rarely cited barrier to clinical trial participation.

Plasma pTau181 and pTau217 predict asymptomatic amyloid accumulation equally well as amyloid PET.

The dynamic phase of preclinical Alzheimer's disease, as characterized by accumulating cortical amyloid-β, is a window of opportunity for amyloid-β-lowering therapies to have greater efficacy. Biomarkers that accurately predict amyloid-β accumulation may be of critical importance for participant inclusion in secondary prevention trials and thus enhance development of early Alzheimer's disease therapies. We compared the abilities of baseline plasma pTau181, pTau217 and amyloid-β PET load to predict future amyloid-β accumulation in asymptomatic elderly. In this longitudinal cohort study, baseline plasma pTau181 and pTau217 were quantified using single molecule array assays in cognitively unimpaired elderly selected from the community-recruited F-PACK cohort based on the availability of baseline plasma samples and longitudinal amyloid-β PET data (median time interval = 5 years, range 2-10 years). The predictive abilities of pTau181, pTau217 and PET-based amyloid-β measures for PET-based amyloid-β accumulation were investigated using receiver operating characteristic analyses, correlations and stepwise regression analyses. We included 75 F-PACK subjects (mean age = 70 years, 48% female), of which 16 were classified as amyloid-β accumulators [median (interquartile range) Centiloid rate of change = 3.42 (1.60) Centiloids/year). Plasma pTau181 [area under the curve (95% confidence interval) = 0.72 (0.59-0.86)] distinguished amyloid-β accumulators from non-accumulators with similar accuracy as pTau217 [area under the curve (95% confidence interval) = 0.75 (0.62-0.88) and amyloid-β PET [area under the curve (95% confidence interval) = 0.72 (0.56-0.87)]. Plasma pTau181 and pTau217 strongly correlated with each other (r = 0.93, Pfalse discovery rate < 0.001) and, together with amyloid-β PET, similarly correlated with amyloid-β rate of change (r pTau181 = 0.33, r pTau217 = 0.36, r amyloid-β PET = 0.35, all Pfalse discovery rate ≤ 0.01). Addition of plasma pTau181, plasma pTau217 or amyloid-β PET to a linear demographic model including age, sex and APOE-ε4 carriership similarly improved the prediction of amyloid-β accumulation (ΔAkaike information criterion ≤ 4.1). In a multimodal biomarker model including all three biomarkers, each biomarker lost their individual predictive ability. These findings indicate that plasma pTau181, plasma pTau217 and amyloid-β PET convey overlapping information and therefore predict the dynamic phase of asymptomatic amyloid-β accumulation with comparable performances. In clinical trial recruitment, confirmatory PET scans following blood-based prescreening might thus not provide additional value for detecting participants in these early disease stages who are destined to accumulate cortical amyloid-β. Given the moderate performances, future studies should investigate whether integrating plasma pTau species with other factors can improve performance and thus enhance clinical and research utility.

Improving Transparency of NHS Trust uses of data for Research Purposes

BackgroundIn 2022, the UK Health Data Research Alliance published a Data Transparency Standards white paper (UK Health Data Research Alliance, 2022). This guideline encourages organisations using health data for research to take an approach which creates increased transparency around how this data is utilised and what the proposed benefits of projects may be. The guidelines are split into six themed standards encouraging organisations to; publish their application forms and application process, have a clearly marked website which considers their target audience and is regularly reviewed, and to publish a register of projects which have used their data. IntroductionMFT CDSU operates a Safe Haven for research using health and social care data which includes a public panel for reviewing project applications. As such, it was felt that adopting the Data Transparency Standards would be a crucial step in furthering our public involvement and transparency of operations within the service. MethodsCDSU and RCD adapted the already existing MFT intranet site to be an outward-facing public website (Figure 1), hosted on the MFT Research and Innovation website and accessible for two main audiences; public citizens and researchers. Existing processes and descriptions were adapted to try and meet the Data Transparency Standards in the best-fit way, working within the constraints of existing Trust site infrastructure and publishing rules, and content was reviewed by the RCD. Agreed content and website structure was then sent to the CDSU Data Access Committee (DAC) for review and approval before publishing on the website. ResultsA public-facing website was published near the end of March 2024 with dedicated sections for CDSU workstreams (Figure 2) of Operational Data Science, Research Data and Clinical Trials Recruitment and a direct means to contact CDSU. The DAC has its own dedicated tab (Figure 3) explaining their role in reviewing projects, listing all projects which have received approvals so far. ConclusionsThe website is published (https://research.cmft.nhs.uk/innovation-at-mft/manchester-clinical-data-science-unit) but will still require some further edits to the content. There is also a planned change for the MFT content management site so there may be some temporary disruption while this move is enabled. There is an existing schedule in place to review the site content for relevance every 6 months. There are constraints on content and structure due to the MFT comms rules on publications and the content management site MFT use. This meant that we are unable to easily meet certain criteria in the Data Transparency Standards, such as structuring the content in a particular way or providing a downloadable copy of files. The CDSU website will be a useful engagement tool, encouraging more interest in the service and types of project undertaken and we are working to make more information available. References UK Health Data Research Alliance (2022), Improving transparency in the use of health data for research: Recommendations for a data use register standard, https://zenodo.org/records/5902743#.ZDgTHcrMKUn MFT Clinical Data Science Unit (2024), https://research.cmft.nhs.uk/innovation-at-mft/manchester-clinical-data-science-unit

Changes in patient recruitment parameters and their derivatives under the influence of external factors – population size and density of residence in a certain area

Background. The lack of targeted patient recruitment for clinical trials reaches 90%, which leads to failures of a trial as a whole and insufficient access to the necessary treatment or diagnostic method for patients. To find out the reasons for recruitment failures, many factors are considered, the action of which is difficult to assess due to high variability. In general, various factors are named that reduce patient recruitment, while factors that improve it are much less known.Objective: to investigate changes in the parameters and indicators of patient recruitment for clinical trials depending on the influence of external factors.Material and methods. A retrospective analysis of four international multicenter clinical trials of phases II–III was performed by 16 patient recruitment parameters and their 6 derivatives (indicators) – both widely used in the literature and newly proposed. A total of 622 patients from 70 clinical centers located in 59 cities of Russia, Ukraine, and Belarus were included in the study. The methods of descriptive statistics and typing were used. To study the influence of factors, internal and external factors were selected, external factors including population size, area and density of residence were analysed, and changes in parameters and indicators depending on the influence of each factor were examined. The area and population density were studied in inseparable connection with each other.Results. A simple classification of factors was proposed – external and internal to the clinical center where patients were recruited. The factors classified as external were analyzed depending on the change in the proposed parameters of patient recruitment for clinical trials and their relationships – indicators (derivatives). The final rate of patient recruitment and the final number of patients recruited in the population group of 1–2 million people had statistically significant (p&lt;0.05) higher values (0.57±0.20 and 15.08±5.06, respectively) than in group with up to 1 million people – 0.14±0.05 and 3.75±1.24.Conclusion. For the first time, an extended panel of parameters and indicators that allow evaluating the influence of various factors on patient recruitment for clinical trials was proposed. The value of the proportion of parameters and indicators that had statistical differences among themselves in the group influenced by the population size factor was more than twice as large as the proportion of similar parameters and indicators in the group influenced by area and population density: 47% and 23%, respectively, which may indicate more strong influence of the first factor.

Exploring attitudes toward xenotransplantation: A scoping review of healthcare workers, healthcare students, and kidney patients.

Recent advances mean that formal clinical trials of solid organ xenotransplantation are increasingly likely to begin and patients requiring a kidney transplant could be the first participants. Healthcare workers and healthcare students constitute the current and future workforce that will influence public opinion of xenotransplantation. The attitudes of these populations are important to consider before recruitment for formal clinical trials begins. This scoping review was reported according to the PRISMA extensions for scoping reviews checklist and the Joanna Briggs Institute methodology for scoping reviews. The Scopus, PubMed, and ScienceDirect databases were searched to identify articles that studied the attitudes of healthcare workers, healthcare students, or kidney patients toward xenotransplantation. The search generated 816 articles, of which 27 met the eligibility criteria. The studies were conducted in 14 different countries on five different continents. Participants from the 27 studies totaled 29,836-this was constituted of 6,223 (21%) healthcare workers, 21,067 (71%) healthcare students, and 2,546 (8%) kidney patients. All three groups had an overall positive attitude toward xenotransplantation. However, in studies where participants were asked to consider xenotransplantation when the risks and results were not equal to allotransplantation-the overall attitude switched from positive to negative. The results also found that Spanish-speaking populations expressed more favorable views toward xenotransplantation compared to English-speaking populations. The results of this review suggest that while attitudes of the three groups toward xenotransplantation are-on the face of it-positive, this positivity deteriorates when the risks and outcomes are framed in more clinically realistic terms. Only formal clinical trials can determine how the risks and outcomes of xenotransplantation compare to allotransplantation.

The role of artificial intelligence in optimising patient recruitment for breast cancer clinical trials

The role of artificial intelligence in optimising patient recruitment for breast cancer clinical trials

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.

Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem. We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies. We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women's decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women's willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention's risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women's participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people. This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women's engagement, participation, and trust in such trials.

Automated Clinical Trial Cohort Definition and Evaluation with CQL and CDS-Hooks.

Patient recruitment for clinical trials faces major challenges with current methods being costly and often requiring time-consuming acquisition of medical histories and manual matching of potential subjects. Designing and implementing an Electronic Health Record (EHR) and domain-independent automation architecture using Clinical Decision Support (CDS) standards that allows researchers to effortlessly enter standardized trial criteria to retrieve eligibility statistics and integration into a clinician workflow to automatically trigger evaluation without added clinician workload. Cohort criteria are translated into the Clinical Quality Language (CQL) and integrated into Measures and CDS-Hooks for patient- and population-level evaluation. Successful application of simplified real-world trial criteria to Fast Healthcare Interoperability Resources (FHIR®) test data shows the feasibility of obtaining individual patient eligibility and trial details as well as population eligibility statistics and a list of qualifying patients. Employing CDS standards for automating cohort definition and evaluation shows promise in streamlining patient selection, aligning with increasing legislative demands for standardized healthcare data.

Sociotechnical feasibility of natural language processing-driven tools in clinical trial eligibility prescreening for Alzheimer's disease and related dementias.

Alzheimer's disease and related dementias (ADRD) affect over 55 million globally. Current clinical trials suffer from low recruitment rates, a challenge potentially addressable via natural language processing (NLP) technologies for researchers to effectively identify eligible clinical trial participants. This study investigates the sociotechnical feasibility of NLP-driven tools for ADRD research prescreening and analyzes the tools' cognitive complexity's effect on usability to identify cognitive support strategies. A randomized experiment was conducted with 60 clinical research staff using three prescreening tools (Criteria2Query, Informatics for Integrating Biology and the Bedside [i2b2], and Leaf). Cognitive task analysis was employed to analyze the usability of each tool using the Health Information Technology Usability Evaluation Scale. Data analysis involved calculating descriptive statistics, interrater agreement via intraclass correlation coefficient, cognitive complexity, and Generalized Estimating Equations models. Leaf scored highest for usability followed by Criteria2Query and i2b2. Cognitive complexity was found to be affected by age, computer literacy, and number of criteria, but was not significantly associated with usability. Adopting NLP for ADRD prescreening demands careful task delegation, comprehensive training, precise translation of eligibility criteria, and increased research accessibility. The study highlights the relevance of these factors in enhancing NLP-driven tools' usability and efficacy in clinical research prescreening. User-modifiable NLP-driven prescreening tools were favorably received, with system type, evaluation sequence, and user's computer literacy influencing usability more than cognitive complexity. The study emphasizes NLP's potential in improving recruitment for clinical trials, endorsing a mixed-methods approach for future system evaluation and enhancements.

Exploring the Strategic Use of TikTok for Clinical Trial Recruitment: How audiences’ Prior Short-Form Video Usage Influences Persuasive Effects

Guided by the elaboration likelihood model and framing theory, this study explores the potential of short-form video platforms (e.g. TikTok), for targeted clinical trial recruitment. An online experiment compared doctor vs. peer-led videos addressing logistical or psychological barriers to participation, mimicking common TikTok communication tactics. Results indicate that high (vs. low) TikTok users are more persuaded by recruitment messages, and they exhibit stronger intentions to participate in clinical trials. Although doctor-sourced messages generate greater credibility and a more favorable message attitude, peer-sourced messages may be more effective in increasing participation intention. Lastly, doctor-sourced videos that address logistical barriers and peer-sourced videos that discuss psychological barriers result in higher self-efficacy for clinical trial participation. This study contributes to the growing body of research on new media’s role in health communication and provides insights into how to strategically utilize TikTok and other short-form video platforms for clinical trial recruitment.

BRD4L cooperates with MYC to block local tumor invasion via suppression of S100A10

Targeted therapy based on BRD4 and MYC shows promise due to their well-researched oncogenic functions in cancer, but their tumor-suppressive roles are less understood. In this study, we employ a systematic approach to delete exons that encode the low-complexity domain (LCD) of BRD4L in cells by using CRISPR–Cas9. In particular, the deletion of exon 14 (BRD4–E14) results in cellular morphological changes towards spindle-shaped and loosely packed. BRD4–E14 deficient cells show increased cell migration and reduced cell adhesion. The expression of S100A10 was significantly increased in cells lacking E14. BRD4L binds with MYC via the E14-encoded region of the LCD to inhibit the expression of S100A10. In cancer tissues, there is a positive correlation between BRD4 and MYC, while both of these proteins are negatively associated with S100A10 expression. Finally, knocking out the BRD4–E14 region or MYC promotes tumor growth in vivo. Together, these data support a tumor-suppressive role of BRD4L and MYC in some contexts. This discovery emphasizes the significance of a discreetly design and precise patient recruitment in clinical trials that testing cancer therapy based BRD4 and MYC.

Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial

BackgroundLow back pain (LBP) is a significant public health problem, is very prevalent, and is often characterized by the persistence of symptoms. Transcutaneous electrical nerve stimulation (TENS) may benefit people with chronic LBP because it can activate descending inhibitory pathways and inhibit central excitability. However, previous studies that have investigated the effects of TENS on pain in people with LBP have failed to use proper intensities of current, and the timing of the assessment of pain was not performed during the peak of the analgesic response or functional activities. Therefore, the present study aims to assess the effects of TENS on measures of pain, function, and descending inhibition using the maximal tolerable intensity of TENS in participants with LBP.Methods/designThis study will be a randomized crossover trial. The participants for this study will be recruited from various places, including the University of Hartford, physical therapy clinics, and local businesses in the Hartford area, as well as online websites geared towards clinical trial recruitment. A total of 34 participants will receive all three treatments: active TENS, placebo TENS, and no treatment control. The treatment order will be randomized using a website-based randomization tool. For active TENS, a modulating frequency of 2–125 Hz will be applied with a variable pulse duration and maximal tolerable intensity for 30 min. The TENS will be left on for post-treatment testing to assess the effects during its maximally effective period for a total of 50 to 60 min. Furthermore, the intensity may be turned down if muscle twitching is present to ensure blinding of the evaluator. For placebo TENS, the unit will deliver current for 45 s, ramping to 0 in the last 15 s. The primary outcome will be pain intensity at rest and with movement, determined using the numerical pain rating scale. The secondary outcomes will be pressure pain threshold, heat pain threshold, temporal summation of pain, conditioned pain modulation, sit-to-stand test, and repeated trunk flexion. The assessments will be performed immediately before and after treatment. Statistical analysis of the data obtained will consider a significance level of p < 0.05.DiscussionThis study will provide evidence concerning the effects and mechanisms of TENS treatment in participants with chronic non-specific low back pain. The outcomes, including pain, function, and descending inhibition, will help us gain a greater understanding of how TENS can be used for these participants.Trial registrationClinicalTrials.gov NCT05812885. Registered on 24th May 2023.

RecruIT: A cloud-native clinical trial recruitment support system based on Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM)

BackgroundClinical trials (CTs) are foundational to the advancement of evidence-based medicine and recruiting a sufficient number of participants is one of the crucial steps to their successful conduct. Yet, poor recruitment remains the most frequent reason for premature discontinuation or costly extension of clinical trials. MethodsWe designed and implemented a novel, open-source software system to support the recruitment process in clinical trials by generating automatic recruitment recommendations. The development is guided by modern, cloud-native design principles and based on Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) as an interoperability standard with the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) being used as a source of patient data. We evaluated the usability using the system usability scale (SUS) after deploying the application for use by study personnel. ResultsThe implementation is based on the OMOP CDM as a repository of patient data that is continuously queried for possible trial candidates based on given clinical trial eligibility criteria. A web-based screening list can be used to display the candidates and email notifications about possible new trial participants can be sent automatically. All interactions between services use HL7 FHIR as the communication standard. The system can be installed using standard container technology and supports more sophisticated deployments on Kubernetes clusters. End-users (n = 19) rated the system with a SUS score of 79.9/100. ConclusionWe contribute a novel, open-source implementation to support the patient recruitment process in clinical trials that can be deployed using state-of-the art technologies. According to the SUS score, the system provides good usability.

The overlap between randomised evaluations of recruitment and retention interventions: An updated review of recruitment (Online Resource for Recruitment in Clinical triAls) and retention (Online Resource for Retention in Clinical triAls) literature.

The Online Resource for Recruitment in Clinical triAls (ORRCA) and the Online Resource for Retention in Clinical triAls (ORRCA2) were established to organise and map the literature addressing participant recruitment and retention within clinical research. The two databases are updated on an ongoing basis using separate but parallel systematic reviews. However, recruitment and retention of research participants is widely acknowledged to be interconnected. While interventions aimed at addressing recruitment challenges can impact retention and vice versa, it is not clear how well they are simultaneously considered within methodological research. This study aims to report the recent update of ORRCA and ORRCA2 with a special emphasis on assessing crossover of the databases and how frequently randomised studies of methodological interventions measure the impact on both recruitment and retention outcomes. Two parallel systematic reviews were conducted in line with previously reported methods updating ORRCA (recruitment) and ORRCA2 (retention) with publications from 2018 and 2019. Articles were categorised according to their evidence type (randomised evaluation, non-randomised evaluation, application and observation) and against the recruitment and retention domain frameworks. Articles categorised as randomised evaluations were compared to identify studies appearing in both databases. For randomised studies that were only in one database, domain categories were used to assess whether the methodological intervention was likely to impact on the alternate construct. For example, whether a recruitment intervention might also impact retention. In total, 806 of 17,767 articles screened for the recruitment database and 175 of 18,656 articles screened for the retention database were added as result of the update. Of these, 89 articles were classified as 'randomised evaluation', of which 6 were systematic reviews and 83 were randomised evaluations of methodological interventions. Ten of the randomised studies assessed recruitment and retention and were included in both databases. Of the randomised studies only in the recruitment database, 48/55 (87%) assessed the content or format of participant information which could have an impact on retention. Of the randomised studies only in the retention database, 6/18 (33%) assessed monetary incentives, 4/18 (22%) assessed data collection location and methods and 3/18 (17%) assessed non-monetary incentives, all of which could have an impact on recruitment. Only a small proportion of randomised studies of methodological interventions assessed the impact on both recruitment and retention despite having a potential impact on both outcomes. Where possible, an integrated approach analysing both constructs should be the new standard for these types of evaluations to ensure that improvements to recruitment are not at the expense of retention and vice versa.

Willingness and motivation of Egyptian patients with diabetic retinopathy to participate in clinical trials

Purpose The aim of this study was to identify the motivational factors and the barriers of Egyptian diabetic retinopathy (DR) patients to recruitment in clinical trials. Patients and methods This is a cross-sectional study of the patients with diabetes mellitus attending the Outpatient Clinic of Zagazig University Hospital from September 2022 to December 2022. Patients with any degree of DR were included. A questionnaire was distributed to all participants. It included the sociodemographic and clinical characteristics and questions to identify the motivational factors or the barriers to participate in a clinical trial. The patients were categorized into two groups according to their tendency for recruitment: the first group that accepted participation, who were asked about the most motivational factors and the second group that refused participation, who were asked about their potential barriers. Results The study recruited 206 DR patients of whom 145 (70.4%) accepted to participate in clinical trials, while the remaining 61 (29.6%) patients refused to participate. Fear from blindness was the commonest motivational factor (93.1%) and the risk of side effects was the commonest barrier (100%). Acceptance to participate was higher among those with positive family history of diabetes mellitus (P=0.01). Refusal to participate was higher in mild nonproliferative DR patients (P&lt;0.001), while patients with proliferative DR and macular edema significantly accepted to participate (P&lt;0.001). High education was significantly associated with acceptance compared to those who refused to participate (81.1 vs. 18.9%, respectively, P=0.004). Ocular history of previous intervention was significantly associated with acceptance to participate (P=0.001). Conclusion Acceptance of DR Egyptian patients to participate in clinical trials was unpredictably high. The results of this questionnaire should encourage researchers to conduct more clinical trials.

Brief Report on Global Clinician Practices in the First-Line Management of Metastatic Non-Small Cell Lung Cancer

IntroductionIn the dynamic landscape of metastatic NSCLC (mNSCLC) management, marked by several frontline options and the integration of next generation sequencing (NGS) for informed decision-making, barriers persist despite advancements. This includes challenges in clinical trial recruitment. To gain global insights into clinicians’ practices, we conducted a survey on their testing and management approaches for patients with mNSCLC. MethodsThe survey, conducted from July 12 to August 20, 2023, utilized multiple-choice questions and qualitative research questions, employing the Likert Scale for comprehensive insights. ResultsA total of 127 individuals responded, with 72% affiliated with academic health systems, and 55% practicing in the USA. Regarding testing practices, 93% consistently ordered NGS for non-squamous histology, while 54% did so for squamous cell histology. Concurrent tissue and liquid biopsies were routinely ordered by 28%, while 39% reported ordering both testing platforms concurrently for select cases only. Respondents cited logistical barriers, such as insufficient tissue and lack of infrastructure, as the most common hindrance to molecular testing (76%), followed by reimbursement challenges (56%) and concerns about delayed turnaround time (50%). While most respondents were confident in interpreting NGS results, 22% lacked confidence. Concerning treatment decisions, 72% preferred awaiting molecular testing results before initiating systemic therapy. Less than 50% routinely referred patients for clinical trials in the frontline setting for mNSCLC. For patients with disease expressing high PD-L1 levels, most oncologists preferred pembrolizumab monotherapy. For disease with low PD-L1 expression, a platinum doublet chemotherapy regimen combined with pembrolizumab was favored. In disease cases with negative PD-L1 expression, a platinum doublet chemotherapy regimen with pembrolizumab was preferred. Key factors influencing oncologists' preferred immune checkpoint inhibitor (ICI) included experience with one ICI over another, preferred status per national guidelines, availability of trial data with a significant follow-up period, and consideration of drug cost. ConclusionAlthough this study demonstrates an improved awareness and adoption of ordering NGS for the management of mNSCLC, it underscores the persistence of various barriers that must be addressed to improve upon the quality of care for patients diagnosed with mNSCLC.

92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse

OBJECTIVES/GOALS: To describe an Honest Broker (HB) tool and workflow integrated with the Institutional Review Board (IRB) to automate requests, approvals and delivery of both de-identified and identified data extractions from a clinical research data warehouse (CRDW). METHODS/STUDY POPULATION: The HB tool has predefined domain tables and is closely integrated IRB for quick and easy review and approval. Investigators can access patient data using query tools, barcodes from biospecimens or build a query in TriNetX and provide the patient list as an input for the HB tool. For de-identified data extraction, the required data domain tables and date ranges can be selected and submitted in the HB tool. For identified data extractions, investigators with an approved IRB protocol can enter the protocol number and the approved date range in the HB tool. This request is automatically forwarded to the IRB for review. RESULTS/ANTICIPATED RESULTS: For de-identified data extraction, an email alert is automatically sent to the investigator once the data extract is completed. For identified data extraction, if IRB approves the request, an HB is immediately notified to release the data. Data release triggers two emails to the investigator: (1) a link to an encrypted zipped file with the requested data, and (2) a password to unlock the encrypted file. If the request is denied, the IRB sends an email to the investigator with the reason for denial and options for remediation. The entire HB workflow is accomplished in a secure environment with an audit trail from the initial data request to data download by the investigator. Since the launch of the HB tool, the time from data request to delivery is approximately an hour for deidentified data and 24 hrs for identified data. DISCUSSION/SIGNIFICANCE: The HB tool has increased successful data delivery in support of publications, grant submissions, and clinical trial recruitment. Optimization of data extraction from the CRDW through automation and integration with the IRB can minimize interaction with data analysts and IRB staff, thus accelerating the conduct of clinical research.

A service-oriented approach to clinical trial recruitment for dementia and brain health: Methods and case examples of MyAlliance for Brain Health.

Recruitment of sufficient and diverse participants into clinical research for Alzheimer's disease and related dementias remains a formidable challenge. The primary goal of this manuscript is to provide an overview of an approach to diversifying research recruitment and to provide case examples of several methods for achieving greater diversity in clinical research enrollment. The University of Kansas Alzheimer's Disease Research Center (KU ADRC) developed MyAlliance for Brain Health (MyAlliance), a service-oriented recruitment model. MyAlliance comprises a Primary Care Provider Network, a Patient and Family Network, and a Community Organization Network, each delivering tailored value to relevant parties while facilitating research referrals. We review three methods for encouraging increased diversity in clinical research participation. Initial outcomes reveal an increase in underrepresented participants from 17% to 27% in a research registry. Enrollments into studies supported by the research registry experienced a 51% increase in proportion of participants from underrepresented communities. MyAlliance shifts power, resources, and knowledge to community advocates, promoting brain health awareness and research participation, and demands substantial financial investment and administrative commitment. MyAlliance offers valuable lessons for building sustainable, community-centered research recruitment infrastructure, emphasizing the importance of localized engagement and cultural understanding. MyAlliance led to a significant increase in the representation of underrepresented racial and ethnic groups and individuals from rural areas.The service-oriented approach facilitated long-term community engagement and trust-building, extending partnerships between an academic medical center and community organizations.While effective, MyAlliance required substantial financial investment, with costs including infrastructure development, staff support, partner organization compensation, and promotional activities, underscoring the resource-intensive nature of inclusive research recruitment efforts.

Using X, Facebook QR codes to optimise recruitment to a feasibility trial Enhancing Men’s Awareness of Testicular Diseases (E-MAT) in a cluster randomised Study Within A Trial (SWAT): Lessons learned.

Background Eight out of ten adults use social media, yet its efficacy in recruitment in clinical trials remains under-explored. The purpose of this SWAT was to determine which recruitment method, X, Facebook or QR code via posters, was more efficient and cost effective for recruiting participants to the host trial. Methods A cluster randomised cross-over design evaluated three recruitment strategies, X, Facebook and QR code. Seven Gaelic Athletic Association (GAA) clubs were randomised to receive either X, Facebook, or QR code. The seven clubs were re-randomised twice more, two weeks apart. There were two primary outcomes: 1. proportion of participants who consent to participate, relative to the number of players contacted; and 2. proportion of participants who consent to participate, relative to the number of players who clicked the link to register their interest. Results Fifty participants were randomised to three recruitment methods, and 47 were retained in the host trial. Participants mainly heard about the study through friends, with some engagement via social media platforms Facebook and X, and little to no engagement with the QR code. Primary outcomes were hindered by the inability to disaggregate data by GAA club. Economic outcomes revealed QR code as the costliest strategy, and while X was cheaper than Facebook in terms of the number of clicks, Facebook demonstrated better recruitment and retention and thus reduced the costs per participant. Conclusions While the inability to disaggregate data by club was a limitation, the study revealed that Facebook outperformed X and QR codes in terms of recruitment and participant retention and was thus considered to be more cost effective. The findings emphasise the importance of considering engagement patterns and cost-effectiveness in designing recruitment strategies for clinical trials, especially within the dynamic landscape of social media use.

Recruitment and retention of clinical trial participants: understanding motivations of patients with chronic pain and other populations.

This paper aims to present and discuss the issues, challenges, and strategies related to recruitment and retention in clinical trials involving participants with chronic pain. The randomized controlled clinical trial (RCT) is widely regarded as the gold standard for evaluating clinical interventions. However, it is crucial to acknowledge and address the challenges associated with recruiting and retaining participants. To prioritize the experience of the study population, targeted outreach strategies and a patient-centric approach are necessary. Researchers should consider incorporating recruitment and retention strategies during the study design phase. Implementing multi-pronged recruitment methods, leveraging relationships with community providers, and involving representatives of the patient population are helpful approaches. Effective communication and maintaining a professional environment are vital for optimizing engagement and supporting the successful execution of clinical trials involving participants with chronic pain.