Trial Sites Research Articles

NIMG-41. MULTI-SITE, PROSPECTIVE TRIAL EVALUATING FET-PET IN GLIOBLASTOMA (FIG) STUDY (TROG 18.06): PRELIMINARY RESULTS OF CENTRAL NUCLEAR MEDICINE REVIEW OF FET-PET BIOLOGIC TARGET VOLUME DELINEATION FOR RADIATION PLANNING

Abstract BACKGROUND To provide an update from the multi-site trial evaluating O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET) in Glioblastoma (FIG) study and 2) assess the impact of central Nuclear Medicine physician (NMP) review of prospective FET-PET1 delineation of the biological target volume (BTV) for radiotherapy (RT) planning. Material and methods Up to 210 adult GBM participants across 11 Australian sites will undergo FET-PET post-surgery/pre-chemo-RT [CRT] (FET-PET1), one month post CRT (FET-PET2) and at suspected progression (FET-PET3). Group 1 participants enter at timepoint 1 (FET-PET1 with MRI1), with Group 2 entering at timepoint 2. Adjuvant RT target volumes are derived per standard contrast MRI with hybrid post-hoc RT volumes then incorporating the FET-PET1 NM-derived BTV utilising MiM version 7.0. All trial sites and NMP have passed credentialling which included three benchmarking cases involving BTV delineation. RESULTS Trial recruitment commenced in January 2021, with 189 (n=126 Group 1 and n=63 Group 2) participants enrolled to date, with a target of 140 Group 1 participants. During trial credentialling, results demonstrated variations in FET-PET1-derived BTV in 25/72 (34.7%) - 13 minor and 12 major.Currently, 42 of 112 participant FET-PET1 with BTV delineation cases across 10 sites have undergone central review, with 7/42 (16.7%) requiring resubmission. Reasons for resubmission/protocol deviation included incorrect imaging sequence selection within the MiM workflow (n=3), Static GTV overcontouring (n=3) and dynamic volume of interest change in size/position during MiM workflow use (n=1). CONCLUSION The FIG trial will complete recruitment in 2024 with analyses planned at one year post CRT completion. Despite improvements in resubmission rates compared to the credentialling phase, central review of prospective FET-PET1-derived BTV delineation remains important in ensuring protocol adherence. The FIG study is the largest prospective multi-site study of its kind addressing FET-PET’s impact on adjuvant radiation planning and its role in management of pseudoprogression and prognostication.

Short-course subcutaneous treatment with birch pollen allergoids greatly improves symptom and medication scores in birch allergy.

Subcutaneous immunotherapy has emerged as an effective option for treating allergic diseases. Here, we assessed the clinical impact of the mannan-conjugated birch pollen polymerized allergoid T502 in birch pollen-induced allergic rhinoconjunctivitis. In this prospective, randomized, double-blind placebo-controlled phase III trial, 298 birch pollen-allergic adult patients were treated across 28 trial sites in Germany. Patients received either placebo or 23,000 mTU T502 subcutaneously over five pre-seasonal visits. Efficacy was assessed by comparing the combined symptom and medication score (CSMS) between placebo and T502 during the peak birch pollen season 2022. Safety, tolerability and immunologic effects were also analyzed. During the peak birch pollen season, the median CSMS of the T502 group was reduced by 33% (p = 0.002) compared to placebo. The median daily symptom score and daily medication score were reduced by 30.4% (p < 0.001) and 56.3% (p = 0.045), respectively. Health related quality of life improved as reflected by reduction of RQLQ values by 31.5% (p < 0.0001). Production of Bet v 1 sIgG4 and Bet v 1 sIgG increased up to 6.2-fold and 3-fold respectively in the T502 group (p < 0.0001). The sIgE/sIgG4 ratio was strongly reduced in the T502 group at V7 (-62.9%, p < 0.0001). No fatalities nor serious adverse events were reported. In total, 16 systemic allergic reactions occurred (Grade I/II). Treatment with T502 significantly reduced symptoms and medication need in rhinoconjunctivitis patients. The treatment is well tolerated and safe.

Groundnut (Arachis hypogaea L.) Response to Nitrogen Fertilizer and Earthing Up Practices in the Tigray Region of Ethiopia

To increase groundnut yields, integrated agronomic techniques must be implemented. The current study focuses on using starter nitrogen fertilizer in conjunction with earthing up for groundnut cultivation. Three replications and a factorial combination were used in the complete randomized block design of the experiment. Two types of earthing up (no earthing up and earthing up) and four levels of nitrogen fertilizer (0, 15, 30, and 45 kg ha-1) were used in the treatment combinations. For each of the Hamedo 1 and Hamedo 2 experimental sites, two undisturbed and two disturbed composite soil samples were collected at a depth of 20 cm before sowing. The data analysis showed that neither the combination application of N fertilizer and earthing up nor the individual independent applications of N fertilizer and earthing up had a significant effect on groundnut flowering and maturity. Groundnut plant height, number of branches per plant, number of pods per plant, number of seeds per plant, seed weight per plant, and haulm yields were not significantly affected by earthing up alone or by the co-application of nitrogen fertilizer and earthing up. On the other hand, the exclusive use of nitrogen fertilizer significantly affected groundnut plant height, the number of branches per plant, the number of pods per plant, the number of seeds per plant, seed weight per plant, and haulm yield. Applying 45 kg ha-1 of nitrogen fertilizer to the Hamedo 1 and Hamedo 2 trial sites enhanced the haulm yield by 70.53% and 78.76%, respectively, compared to the unfertilized plots. Individual applications of nitrogen fertilizer, earthing up, or a combination of both had a significant effect on groundnut pod and kernel yields. In comparison to plots that received a combined application of 45 kg ha-1 of nitrogen fertilizer and earthing up, the Hamedo 1 and Hamedo 2 trial sites exhibited increases in pod yields of 57.73% and 55.97%, respectively, when earthing up was combined with 15 kg ha-1 of nitrogen fertilizer. In the same way, applying 15 kg ha-1 of nitrogen fertilizer to the earthing-up soil in the Hamedo 1 and Hamedo 2 experimental sites boosted the kernel yields by 70.05% and 75.43%, respectively, in comparison to soil earthing-up plots that received 45 kg ha-1 nitrogen. The findings of the economic and agronomic analyses showed that applying nitrogen fertilizer and earthing up together greatly increases groundnut yields and revenues. Therefore, to increase groundnut yields and receive more financial advantages, farmers can consider the combined application of 15 kg ha-1 of nitrogen fertilizer and earthing-up.

A Pilot Study on the Collection of Adverse Event Data from the Patient Using an Electronic Platform in a Cancer Clinical Trial Unit.

Accurate and robust adverse event (AE) data collection is crucial in cancer clinical trials to ensure participant safety. Frameworks have been developed to facilitate the collection of AE data and now the traditional workflows are facing renewal to include patient-reported data, improving completeness of AE data. We explored one of these workflows in a cancer clinical trial unit. The study was a single-site study conducted at a tertiary hospital located in Australia. Patients consenting to a clinical trial were eligible for inclusion in this study. Participants used an electronic platform-My Health My Way (MHMW)-to report their symptomatic data weekly for 24 weeks. A symptom list was included within the platform, along with a free text field. Data reported via the platform was compared with data recorded in the patient's medical chart. Time taken to compile data from each source was recorded, along with missing data points. Agreement between patient-reported data and data recorded in the medical notes was assessed using Kappa and Gwet's AC1; time taken to compile data and missing data points were assessed using a Wilcoxon signed rank test. Low agreement was found between patient- and clinician-reported data (-0.482 and -0.159 by Kappa and Gwet's AC1 respectively). Only 127 (30%) of the total 428 AEs were reported by both MHMW and medical notes. Patients reported higher rates of symptoms from the symptom list, while clinicians reported higher rates of symptoms outside of the symptom list. Time taken to compile the data from MHMW was significantly less than that taken to review medical notes (2.19min versus 5.73min respectively; P < 0.001). There were significantly less missing data points from the MHMW data compared with the medical notes (1.4 versus 7.8; P<0.001). This study confirms previous reports that patient- and clinician-reported adverse event data show low agreement. This study also shows that clinical trial sites could significantly reduce the work performed by research staff in the collection of adverse event data by implementing an electronic, patient-reported platform.

Differential patient travel burden to pediatric atopic dermatitis clinical trial sites.

Differential patient travel burden to pediatric atopic dermatitis clinical trial sites.

Medical Science Liaisons: A Guide for Advanced Practice Registered Nurses

Medical science liaisons (MSLs) are part of the field medical affairs (FMA) department of pharmaceutical companies and are scientific resources for advanced practice registered nurses (APRNs). Following strict regulations and antikickback statutes, MSLs operate differently from sales and engage in unbiased, nonpromotional scientific exchange to provide clinical resources to APRNs. They also collaborate with shareholders like professional organizations, clinical trial sites, and academic institutions. Understanding MSL engagement allows APRNs multiple avenues both externally and within the pharmaceutical industry to leverage their experience to enhance clinical practice.

From hurdles to high performance: overcoming day-to-day challenges for successful clinical trials at sites

Randomized clinical trials are fundamental in testing new drugs, medical devices and treatment protocols. They help to determine the efficacy and safety of new treatments, leading to medical innovations that can significantly improve treatment outcomes. Clinical trial sites are the engines that drive medical advancements, but they face numerous challenges in their day-to-day operations and impact the study outcome as well as data quality. Continuous improvement through research and innovation ensures that clinical trials are conducted more effectively, leading to better healthcare advancements and patient outcomes. Execution of clinical trial at the hospital site is a critical task and associated with the new challenges every day which may include patient recruitment, retention and compliance to the data collection. GCP compliance is a soul of clinical research and difficult task to comply with. GCP is a harmonized guideline accepted by most of the countries all across the globe.

The TB vaccine clinical trial centre directory: An inventory of clinical trial centres in Sub-Saharan Africa.

There are over ten vaccine candidates for tuberculosis (TB) in the clinical pipeline that require testing in TB-prevalent populations. To accelerate the clinical development of TB vaccines, a directory of clinical trial centres was established in sub-Saharan Africa (SSA) to assess capacity for conducting late-stage TB vaccine trials. TB vaccine-related parameters were identified, and trial centres in SSA were identified and prioritized based on whether they had experience with TB or non-TB vaccine trials. A survey was sent to identified centres, and the resulting directory presents their capacity for TB vaccine trials. Centres that identified as eligible for TB vaccine trials also had the opportunity to participate to the survey. This article provides an overview of the TB vaccine clinical trial centre directory, including the number and distribution of centres, their general characteristics, and their experience with prior TB vaccine trials. It includes information on the capacity of the centres, such as laboratory biosafety level, patient support, and community engagement. It also includes a case study to demonstrate how the directory can be used to identify trial centres with specific capabilities needed for a particular TB vaccine trial. Of the 134 identified centres, 56 provided information. Of these centres, 51 (91%) had phase 3 clinical trial experience and previous TB trials were conducted at 38 centres. Regarding TB vaccine trials, 19 centres conducted prevention of disease trials, 14 conducted prevention of infection trials, and 27 had no experience with TB vaccine clinical trials. From the respondents, 29 centers in South Africa were identified that could potentially conduct TB vaccine trials, followed by Tanzania (5), Kenya (5), Nigeria (3), and Uganda and Ethiopia (2 each). Trial sites in other countries were underrepresented, based on this survey. The establishment of a clinical trial centre directory can provide a basis for decision-making by various stakeholders. Despite some limitations in survey methodology, the findings suggest opportunities for expanding the evaluation of clinical trial capacity in other disease-prevalent countries and continents. Such data would be valuable in further enriching the Clinical Trial Community which a resource that geographically highlights clinical trial investments and capacities in African research ecosystem. New TB vaccine candidates need to be assessed in clinical trials in countries with high rates of TB in the coming years.An open-access directory of TB vaccine clinical trial centres in sub-Saharan Africa was established, providing an overview of the capacity to conduct clinical trials for TB vaccine candidates (http://www.edctp.org/our-work/coordination-tb-vaccine-funded-research/directory-tb-vaccine-clinical-trial-sites-sub-saharan-africa/).The directory is intended for clinical triallists, funders, policymakers, and researchers to accelerate the clinical development of novel TB vaccines by providing useful information.Regular updates are necessary to ensure the directory remains relevant for vaccine development and feeds into the continental Clinical Trials Community (https://ctc.africa/).

Temporal and Spatial Dynamics of Anthracnose (Colletotrichum sublineolum) Disease on Selected Sorghum Genotypes at Assosa Zone, Western Ethiopia

Background Over 500 million people worldwide rely on sorghum as a main food crop. About 10% of the daily caloric intake of households in Ethiopia’s northwest and eastern regions, including Benishangul Gumuz, comes from sorghum. A hemi-biotrophic fungal pathogen called Colletotrichum sublineolum caused anthracnose disease is among the biotic constraints of sorghum production. Methods Ten selected sorghum genotypes were assessed for sorghum anthracnose severity and its temporal and spatial dynamics on field plots in the districts of Assosa and Bambasi. The performance of the chosen sorghum genotypes was assessed using the following metrics: AUDPC, disease progress rate, yield-related trait, sorghum grain yield, and mean severity index. Anthracnose severity was evaluated using a 1–5 disease rating scale and assessments conducted at seven consecutive time points. Results Ten genotypes of sorghum were examined in the districts of Assosa and Bambasi, with mean anthracnose severity index ranging from 60-77 PSI and 53-82 PSI, respectively. AUDPC varied from 351 to 470 % days and 316 to 499 % days at Assosa and Bambasi districts, respectively. Bambasi district achieved a larger grain yield than the Assosa district. Assosa-1 demonstrated a significant level of disease pressure, yet the current investigation found that this genotype is the highest performing genotype in both locations. Conclusions There is a considerable positive link between the severity of anthracnose and the weekly total rainfall and relative humidity. At both trial sites, Mersa-1 continuously produced higher grain yields and reduced disease levels. Breeders might utilize the Baco Striga sorghum genotype as a check line in a breeding effort to resist anthracnose disease because it shown a high vulnerability to the disease at both locations.

Evaluating an early social communication intervention for young children with Down syndrome (ASCEND): results from a feasibility randomised control trial

BackgroundThis paper reports the results from a feasibility trial of an early parent-delivered social communication intervention for young children with Down syndrome (‘ASCEND’). The intervention focuses on developing children’s early social communication skills, in particular responding to shared attention. The aim was to inform the feasibility of running a full-scale trial through National Health Service (NHS) Speech and Language Therapy (SaLT) services, to assess whether the intervention is effective in improving language skills before children with Down syndrome start school.MethodsThis was a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site, comparing the intervention plus standard NHS SaLT provision with standard NHS SaLT alone. We recruited 20 children with Down syndrome aged between 11 and 36 months through 3 NHS SaLT services, 19 of whom were randomised (10 — intervention group, 9 —control group). Pre- and post-intervention and 6-month follow-up assessments included language, social communication skills, adaptive behaviour, quality of life (parents and children), parental anxiety and depression. The intervention was parent delivered with parents having access to SaLT services and the research team during the intervention. Data were collected on recruitment and retention, standard care, treatment fidelity, acceptability of the intervention by the parents and speech and language therapists, feasibility of collecting health economic measures and suitability of the primary outcome measure.ResultsThe sample was sufficient for a feasibility study. The intervention (manual, support, materials) was positively received by the participating parents. Speech and language therapists also evaluated the acceptability of the intervention positively. Treatment fidelity which was measured by completion of weekly parent diaries and two adherence phone call was acceptable as 100% of the parent diaries were returned, over 90% of the parental diaries were completed correctly and 100% of adherence phone calls were completed. Retention was acceptable at 84% overall. The preliminary health economic data suggest that this intervention will be low cost. The sample size calculation suggests that 290 participants would need to be recruited, with 228 having a complete data set, for a full RCT.ConclusionBased on recruitment, retention and treatment fidelity, as well as the acceptability of the intervention to parents and speech and language therapists, a full-scale trial would be feasible in order to assess the effectiveness of the intervention.Trial registrationISRCTN13902755, registered on 25th August 2020, http://www.isrctn.com/ISRCTN13902755

Emotional competence self-help app versus cognitive behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial.

Effective, scalable interventions are needed to prevent poor mental health in young people. Although mental health apps can provide scalable prevention, few have been rigorously tested in high-powered trials built on models of healthy emotional functioning or tailored to individual profiles. We aimed to test a personalised emotional competence app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to prevent an increase in depression symptoms in young people. This multicentre, parallel, open-label, randomised controlled trial, within a cohort multiple randomised trial (including a parallel trial of wellbeing promotion) was done at four university trial sites in the UK, Germany, Spain, and Belgium. Participants were recruited from schools, universities, and social media from the four respective countries. Eligible participants were aged 16-22 years with increased vulnerability indexed by baseline emotional competence profile, without current or past diagnosis of major depression. Participants were randomly assigned (1:1:1) to usual practice plus either the personalised emotional competence self-help app, the generic CBT self-help app, or the self-monitoring app by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. Outcome assessors were masked to group allocation. The primary outcome was depression symptoms (according to Patient Health Questionnaire-9 [PHQ-9]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Between Oct 15, 2020, and Aug 3, 2021, 1262 participants were enrolled, including 417 to the emotional competence app, 423 to the CBT app, and 422 to the self-monitoring app. Mean age was 18·8 years (SD 2·0). Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. At 3 months, depression symptoms were lower with the CBT app than the self-monitoring app (mean difference in PHQ-9 -1·18 [95% CI -2·01 to -0·34]; p=0·006), but depression symptoms did not differ between the emotional competence app and the CBT app (0·63 [-0·22 to 1·49]; p=0·15) or the self-monitoring app and emotional competence app (-0·54 [-1·39 to 0·31]; p=0·21). 31 of the 541 participants who completed any of the follow-up assessments received treatment in hospital or were admitted to hospital for mental health-related reasons considered unrelated to interventions (eight in the emotional competence app group, 15 in the CBT app group, and eight in the self-monitoring app group). No deaths occurred. The CBT app delayed increases in depression symptoms in at-risk young people relative to the self-monitoring app, although this benefit faded by 12 months. Against hypotheses, the emotional competence app was not more effective at reducing depression symptoms than the self-monitoring app. CBT self-help apps might be valuable public mental health interventions for young people given their scalability, non-consumable nature, and affordability. European Commission.

Emotional competence self-help mobile phone app versus cognitive behavioural self-help app versus self-monitoring app to promote mental wellbeing in healthy young adults (ECoWeB PROMOTE): an international, multicentre, parallel, open-label, randomised controlled trial.

Based on evidence that mental health is more than an absence of mental disorders, there have been calls to find ways to promote flourishing at a population level, especially in young people, which requires effective and scalable interventions. Despite their potential for scalability, few mental wellbeing apps have been rigorously tested in high-powered trials, derived from models of healthy emotional functioning, or tailored to individual profiles. We aimed to test a personalised emotional competence self-help app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to promote mental wellbeing in healthy young people. This international, multicentre, parallel, open-label, randomised controlled trial within a cohort multiple randomised trial (including a parallel trial of depression prevention) was done at four university trial sites in four countries (the UK, Germany, Spain, and Belgium). Participants were recruited from schools and universities and via social media from the four respective countries. Eligible participants were aged 16-22 years with well adjusted emotional competence profiles and no current or past diagnosis of major depression. Participants were randomised (1:1:1) to usual practice plus either the emotional competence app, the CBT app or the self-monitoring app, by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. The primary outcome was mental wellbeing (indexed by the Warwick-Edinburgh Mental Well Being Scale [WEMWBS]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. Outcome assessors were masked to group allocation. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Between Oct 15, 2020, and Aug 3, 2021, 2532 participants were enrolled, and 847 were randomly assigned to the emotional competence app, 841 to the CBT app, and 844 to the self-monitoring app. Mean age was 19·2 years (SD 1·8). Of 2532 participants self-reporting gender, 1896 (74·9%) were female, 613 (24·2%) were male, 16 (0·6%) were neither, and seven (0·3%) were both. 425 participants in the emotional competence app group, 443 in the CT app group, and 447 in the self-monitoring app group completed the follow-up assessment at 3 months. There was no difference in mental wellbeing between the groups at 3 months (global p=0·47). The emotional competence app did not differ from the CBT app (mean difference in WEMWBS -0·21 [95% CI -1·08 to 0·66]) or the self-monitoring app (0·32 [-0·54 to 1·19]) and the CBT app did not differ from the self-monitoring app (0·53 [-0·33 to 1·39]). 14 of 1315 participants were admitted to or treated in hospital (or both) for mental health-related reasons, which were considered unrelated to the interventions (five participants in the emotional competence app group, eight in the CBT app group, and one in the self-monitoring app group). No deaths occurred. The emotional competence app and the CBT app provided limited benefit in promoting mental wellbeing in healthy young people. This finding might reflect the low intensity of these interventions and the difficulty improving mental wellbeing via universal digital interventions implemented in low-risk populations. European Commission.

Clinical research vehicles as a modality for medical research education and conduct of decentralized trials, supporting justice, equity, and diversity in research.

Current clinical research lacks diversity in those that participate. This lack of diversity is concerning given its importance for successful drug development. The frequency and severity of many diseases, along with the pharmacological properties of therapies, can display significant differences based on patient diversity. A clinical trial population that is more reflective of these differences will help researchers better understand the therapeutic profile of the treatment and provide generalizable knowledge to the medical community. The advent of decentralized clinical trial designs is meant to help address this lack of diversity by using portable digital health technologies and virtual interactions to enhance clinical trial access and broaden participation. By leveraging these technologies, trial conduct can occur at locations other than traditional research sites. This shift in trial location may help address some of the logistical, educational, engagement, and trust barriers that have historically prevented enrollment of diverse populations. However, these types of trials still have limitations. Ethical concerns around justice, equity, and diversity will still exist with decentralized clinical trials, which could be mediated using clinical research vehicles. When utilized, this modality may enhance the scientific design and conduct of clinical trials and better follow these ethical principles. These enhancements and improved ethical direction could be accomplished through increasing community involvement, improving health literacy, supporting more diverse trial sites, creating community-based research footholds, fostering connections with researchers, limiting technical challenges, and preventing data security issues.

Opportunities to Improve the Recommendation of Plant Varieties under the Recommended List (RL) System

Recommended List (RL) is the UK plant variety recommendation system introduced in 1944 for supporting growers in making decisions on variety choices. The current RL system is heavily focused on single-trial analyses developed in the 1980s without making full use of information across varieties and trial sites. Given the statistical advances that have been developed and adopted elsewhere, it is timely to review and update the methods for data analysis in RL. In addition, threats from climate change challenge the prediction of variety performance in future environments. Better variety recommendations, particularly for matching varieties to specific environments can be achieved through the improved modeling of effects from genetics, environments, and genetic-by-environment interactions. Here, we evaluate grain yield data from 153 spring barley varieties that were trialed for RL from 2002 to 2019. Our results show that the current RL system produces poor and inconsistent predictions on variety performance across environments. Improvement in RL can be achieved by using mixed models that account for genetic relationships among varieties, and additional improvement is possible if genetic-by-environment interaction can be modeled accurately. We highlight the relevance and importance of genomics in both variety registration and recommendation.

Racial representation in multicenter clinical trials leading to drug approvals for gynecological cancer indications by the US Food and Drug Administration (FDA).

66 Background: Enrollment disparities in gynecologic (Gyn) cancer clinical trials in the United States (US) are well-documented. However, there is limited data evaluating how recruitment sites in international clinical trials contribute to racial representation, specifically in Gyn cancers. Here, we examined racial enrollment and geographic location in clinical trials that have led to approval for Gyn cancer applications. Methods: Agents approved by the FDA for Gyn cancer treatment and corresponding clinical trials were identified from the FDA Drug Approvals and Databases. Enrollment data were abstracted from ClinicalTrials.gov then cross-checked with published manuscripts and FDA labels. Using Gyn disease site prevalence from the 2021 SEER database, we calculated expected enrollment proportions by race and compared these to actual clinical trial enrollment data. The binomial test was used to compare expected vs. observed proportions with White patients as the reference group. Results: From 2014 to 2024, 9 drugs received 22 FDA approvals for ovarian (n=13), endometrial (n=4), or cervical cancer (n=5). These approvals were based on 28 clinical trials enrolling a total of 13,763 patients (75.7% White, 3.4% Black, 12.0% Asian, 8.9% Other/Unknown). These trials included 1 (3.6%) US only study, 3 (10.7%) non-US, primarily Europe-based studies (PAOLA-1, AURELIA, STUDY42 [Europe + Australia]), and 24 (85.7%) international studies across the US and 46 other countries. Considering the distribution of race (White: 86.3%, Black: 8.4%, Asian: 4.9%) of Gyn cancers in the US, Black patients had lower enrollment (45% of expected enrollment) vs. White patients (95% of expected enrollment, P&lt;0.0001). African countries were rarely included among the recruitment sites. Two international trials reported patient recruitment from South Africa (3.2% Black, 6/188 patients, 38% of expected enrollment).However, Asian patients had higher enrollment (269% of expected enrollment, P&lt;0.0001) compared to White patients. In 13 trials that included study sites in East Asia, Asian patients comprised 16% of the trial population (1310/8205 patients; 327% of expected enrollment) vs. 3.2% in trials that did not open in Asia (n=15) (181/5558 patients; 67% of expected enrollment). Conclusions: Black patients were underrepresented in pivotal trials that led to FDA approvals for Gyn cancers. Overrepresentation of Asian patients was likely due to international enrollment from East Asia. Post-marketing retrospective studies or additional studies focused on underrepresented groups are needed to assess true drug efficacy and safety in US populations that are disproportionately affected by Gyn cancer mortality.

Validating claims-based algorithms for a systemic lupus erythematosus diagnosis in Medicare data for informed use of the Lupus Index: a tool for geospatial research

ObjectiveThis study aimed to validate claims-based algorithms for identifying SLE and lupus nephritis (LN) in Medicare data, enhancing the use of the Lupus Index for geospatial research on SLE prevalence...

Patient interest in clinical trials and remote technology among a diverse oncology patient population.

389 Background: Existing research describes a number of barriers limiting cancer clinical trial enrollment, including time constraints and financial burden, particularly among under-represented populations. In this study, we sought to assess the relationship between the use of remote technology in clinical trials and patient interest in trial participation amongst oncology patients at an urban academic medical center. Methods: We administered a 60-question, cross-sectional, in-person survey to adult patients with a solid tumor or hematological malignancy diagnosis on active treatment at Columbia University Irving Medical Center between 1/2023 and 2/2024. The survey assessed patient demographics, telehealth access, and interest in using telehealth as part of routine care and clinical trials. Demographics including age, gender, race/ethnicity, marital status, income, insurance type, education level, and cancer type were self-reported. Results: The survey was administered to 100 oncology patients. The mean age was 61 years; 51% were female; 45% non-White and 23% identified as Hispanic. The majority (87%) reported having access to a computer or electronic device; 99% of those having internet access and 81% being somewhat or very comfortable using the internet. Forty seven percent of patients had been offered a cancer clinical trial by their oncology provider, and 19% had participated or were currently participating in a clinical trial. Of the 53% of patients who had not been offered a clinical trial or did not know, 64% reported they would consider participating in a trial recommended by their oncologist. Among all respondents, 52% of patients reported it would make no difference in their decision to participate in a trial if they learned about the risks and benefits remotely (phone or video), 28% were somewhat more or much more likely to participate learning about the risks and benefits remotely, and 20% were somewhat less or much less likely to participate under these conditions. Seventy five percent of respondents would be willing to sign consent for a trial remotely. Sixty four percent of respondents were not willing to spend over an hour traveling to a trial site, citing time, cost, family, and work obligations as reasons for limiting travel. The majority of respondents (&gt;50%) indicated that they would be more likely to participate if the trial used remote technology to decrease the need to travel to a trial site. Conclusions: In this cross-sectional study amongst a diverse patient population, we found that the majority of oncology patients on active treatment have access to telehealth, express interest in clinical trials despite barriers to participation, and would be more likely to enroll in trials if remote communication reduced the amount of travel time for trial participation. Decreasing the logistical burden of cancer clinical trials may increase patient access and diversity in trial participation.

Training to Increase Minority Enrollment in Lupus Clinical Trials With Community Engagement: Enhancing Lupus Clinical Trial Recruitment Through Provider and Community Health Worker Engagement.

This study evaluates the effectiveness of the Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY) program on enhancing referrals of underrepresented patients to lupus clinical trials. TIMELY leverages two existing American College of Rheumatology online educational initiatives: Materials to Increase Minority Involvement in Clinical Trials (MIMICT), a continuing medical education activity for health care providers, and the community health worker (CHW) Lupus Clinical Trials Training (LuCTT). TIMELY introduced a unique roundtable meeting format to build on the existing online educational programs and facilitate discussions between local clinical trial sites and provider and CHW participants. This study used an online pretest and posttest design to assess changes in theory-based behavioral predictors of lupus clinical trial referrals and engagement (ie, knowledge, attitudes, self-efficacy, and intentions) among providers and CHWs. Participants completed MIMICT or LuCTT and then were eligible to participate in roundtable meetings. Paired t-tests were used to assess changes in composite scores before and after the intervention for each of the outcomes. The final sample included 40 providers and 18 CHWs. Knowledge scores increased significantly for both providers (P < 0.01) and CHWs (P < 0.001) on completion of MIMICT and LuCTT, respectively. After participating in the TIMELY roundtable, providers' composite scores for self-efficacy and intentions significantly increased (P < 0.001). Provider self-efficacy gains were sustained at three months' follow-up (P < 0.001). These promising findings highlight the potential and opportunities for the TIMELY program to improve behavioral predictors of trial referrals, including CHW knowledge and providers' knowledge, self-efficacy, and intentions to refer underrepresented patients to lupus clinical trials.

The OBS UK Dashboard: an interactive tool for representative trial site selection to facilitate equality and diversity in maternity research

BackgroundObstetric Bleeding Study UK (OBS UK) (award ID: 152057) is a National Institute for Health and Care Research (NIHR)-funded stepped wedge cluster randomised controlled trial of a complex intervention for postpartum haemorrhage. This was developed in Wales and evaluated in a feasibility study, with improvements in maternal outcomes observed. Generalisability of the findings is limited by lack of control data and limited ethnic diversity in the Welsh obstetric patient population compared to the United Kingdom (UK): 94% of the Welsh population identifies as White, versus 82% in the UK. Non-White ethnicity and socioeconomic deprivation are linked to increased risk of adverse maternal outcomes. Traditionally, decisions regarding site selection are based on desire to complete trials on target in ‘tried and tested’ research active institutions. To ensure widespread applicability of the results and investigate the impact of ethnicity and social deprivation on trial outcomes, maternity units were recruited that represent the ethnic diversity and social deprivation profiles of the UK.MethodUsing routinely collected, publicly available data, an interactive dashboard was developed that demonstrates the demographics of the population served by each maternity unit in the UK, to inform site recruitment. Data on births per year, ethnic and socioeconomic group of the population for each maternity unit, across the UK, were integrated into the dashboard.ResultsThe dashboard demonstrates that OBS UK trial sites reflect the ethnic and socioeconomic diversity of the UK (study vs UK population ethnicity: White 79.2% vs 81.7%, Asian 10.5% vs 9.3%, Black 4.7% vs 4.0%, Mixed 2.5% vs 2.9%, Other 3.0% vs 2.1%) with variation in site demography, size and location. Missing data varied across sites and nations and is presented.ConclusionThe NIHR equality, diversity and inclusion strategy states studies must widen participation, facilitating individuals from all backgrounds to engage. The development of this novel interactive dashboard demonstrates an innovative way of achieving this. National Health Service (NHS) maternity researchers should consider using this tool to enhance diversity in research, address health disparities and improve generalisability of findings. This approach could be applied to healthcare settings beyond maternity care and across different global populations.Trial registrationISRCTN 17679951. Registered on August 30, 2023.

Exploring implementation of intrapartum trial evidence: a qualitative study with clinicians and clinical academics

BackgroundImplementing research evidence into clinical practice is challenging. This study aim was to explore implementation of two intrapartum trials with compelling findings: BUMPES (position in second stage of labour in nulliparous women with epidural), and RESPITE (remifentanil intravenous patient-controlled analgesia). MethodsA qualitative interview study set in UK National Health Service Trusts and Universities. Purposively sampled investigators from RESPITE and BUMPES trials and clinicians providing intrapartum care: midwives, anaesthetists, and obstetricians, were recruited using existing networks and snowball sampling. Semi-structured virtual interviews were conducted. Thematic analysis was underpinned by Capability Opportunity Motivation Behaviour Change Framework.ResultsTwenty-nine interview participants across 19 maternity units: 11 clinical academics, 10 midwives, 4 obstetricians, 4 anaesthetists. Most (25/29) were aware of one or both trials. BUMPES had been implemented in 4/19 units (one original trial site) and RESPITE in 3/19 units (two trial sites). Access to sufficient resources, training, exposure to interventions, support from leaders, and post-trial dissemination and implementation activities all facilitated uptake of interventions. Some clinicians were opposed to the intervention or disagreed with trial conclusions. However competing priorities in terms of staff time and a plethora of initiatives in maternity care, emerged as a key barrier to implementation.ConclusionsCompelling trial findings were not implemented widely, and numerous barriers and facilitators were identified. Large-scale improvement programmes and evidence-based national guidelines may mean single trials have limited potential to change practice. There is a need to examine how intervention implementation is prioritised to optimise safety outcomes in the context of workforce restrictions, limited resources and large arrays of competing priorities including statutory requirements, that have increased in maternity care.