Trial Network Research Articles

Advancing sustainable implementation of an evidence-based mental health intervention in Sierra Leone’s schools: protocol for a hybrid type 3 implementation-effectiveness trial

BackgroundMental health disorders among youth contribute substantially to the global burden of disease, which is exacerbated in low- and middle-income countries (LMICs) due to large mental health treatment gaps. In Sierra Leone, a West African country with a long history of complex adversity, the mental health treatment gap is estimated at 98%. Implementing innovative mental health interventions that can be sustained at scale is a priority. The Youth Readiness Intervention (YRI) is an evidence-based mental health intervention for youth that can be delivered feasibly by lay health workers/nonspecialists. Using mobile-based technologies to assist implementation could improve the reach and sustainability of the YRI in Sierra Leone. This study aims to train teachers to deliver the YRI in Sierra Leone’s secondary schools and test the feasibility, acceptability, cost, and fidelity to the YRI of a mobile-based supervision model compared with standard, in-person supervision.MethodsWe will conduct a hybrid type 3 implementation-effectiveness cluster randomized trial to assess the feasibility, acceptability, costs and fidelity to the YRI implemented by teachers receiving mobile-based supervision vs. standard supervision. Enrolled schools (N = 50) will be randomized to YRI + mobile supervision (N = 20), YRI + standard supervision (N = 20) or waitlist control (N = 10). We will recruit and enroll four teachers per intervention-condition school (N = 160) and 1200 youth. We will collect data on implementation outcomes among teachers, principals and youth via a mixed methods approach at baseline and post-intervention. We will also collect quantitative data on youth mental health and functioning as secondary outcomes at baseline and post-intervention, as well as cost-effectiveness data at 12-month follow-up.DiscussionStudy findings have the potential to expand the reach of mental health services among youth in low-resource settings via a teacher workforce. The use of mobile tools, if successful, could support further scale out and sustainment of the YRI to other regions of Sierra Leone and West Africa more broadly, which could help address the mental health treatment gap.Trial registrationClinical Trial Network: NCT05737667.

Partnership of I-ACT for children (US) and European pediatric clinical trial networks to facilitate pediatric clinical trials.

Due to a lack of standard pediatric prescribing information, medicines are often used in a dosage form or for an indication that has not been investigated in children. Pediatric clinical trial research networks aim to facilitate the timely availability of innovative drugs for children by developing standardized trial facilitation and conduct processes. This paper aims to assess the (pre)feasibility duration and characteristics of a US-sponsored clinical trial, in collaboration with I-ACT for Children, for distribution across European sites via European clinical research facilitation networks. A transatlantic partnership between the Belgian Pediatric Clinical Research Network (BPCRN,) and I-ACT for Children conducted feasibilities in Europe for industry-sponsored early-stage pharmacological clinical trials between 2019 and 2022. The collaboration recorded time to event for key elements of feasibility, influences on successful feasibility, and benefits of collaboration. Trials were conducted across 17 European countries with 202 participating hospital sites. The initial phase, the pre-feasibility questionnaire had a 70% response rate from 142 sites, and sites took a median 38 days (IQR 20 days) to complete the questionnaire for five trials. All responses underwent a quality control, addressing inaccuracies in site capabilities and recruitment. The first trial's CDA and feasibility questionnaire were completed in roughly 2 months for 7 countries. Time to completion was affected by precontracted sites, limited scope of studies, changes in timelines, COVID-related disruptions, and a learning curve for collaboration. Collaboration between European collaborative national networks and US-network I-ACT for Children has supported site identification of global pediatric clinical trials. This illustrates one method for the importance of early engagement with sponsors and implementation of effective communication systems.

Precipitation causes quality losses of large economic relevance in wheat production

Abstract Adverse weather conditions can affect both crop yield quantity and yield quality. In wheat production, especially the risk of a downgrading due to low baking quality, as indicated by the Hagberg Falling Number, can cause large economic losses after precipitation events. We here estimate precipitation effects on the risk of such a downgrading and quantify the resulting economic losses. To this end, we leverage a panel dataset from the Swiss wheat varieties trial network (N = 1,859) and high-quality weather data. We use a fixed effects estimation framework to estimate precipitation effects and simulate economic losses. We find that precipitation close to harvest significantly increases the risk of a downgrading due to low baking quality. Moreover, downgrading events cause large revenue reductions of up to 1,445 Swiss francs per hectare. This adds new economic insights, highlights the role of weather-dependent crop quality, and provides a basis to improve risk management.

An Update on SARS-CoV-2 Clinical Trial Results-What We Can Learn for the Next Pandemic.

The coronavirus disease 2019 (COVID-19) pandemic has claimed over 7 million lives worldwide, providing a stark reminder of the importance of pandemic preparedness. Due to the lack of approved antiviral drugs effective against coronaviruses at the start of the pandemic, the world largely relied on repurposed efforts. Here, we summarise results from randomised controlled trials to date, as well as selected in vitro data of directly acting antivirals, host-targeting antivirals, and immunomodulatory drugs. Overall, repurposing efforts evaluating directly acting antivirals targeting other viral families were largely unsuccessful, whereas several immunomodulatory drugs led to clinical improvement in hospitalised patients with severe disease. In addition, accelerated drug discovery efforts during the pandemic progressed to multiple novel directly acting antivirals with clinical efficacy, including small molecule inhibitors and monoclonal antibodies. We argue that large-scale investment is required to prepare for future pandemics; both to develop an arsenal of broad-spectrum antivirals beyond coronaviruses and build worldwide clinical trial networks that can be rapidly utilised.

OssaNMA: An R package for using information from network meta-analyses to optimize the power and sample allocation of a new two-arm trial.

Randomized clinical trials (RCTs) are designed for measuring the effectiveness of the treatments and testing a hypothesis regarding the relative effect between two or more treatments. Trial designers are often interested in maximizing power when the total sample size is fixed or minimizing the required total sample size to reach a pre-specified power. One approach to maximizing power proposed by previous researchers is to leverage prior evidence using meta-analysis (NMA) to inform the sample size determination of a new trial. For example, researchers may be interested in designing a two-arm trial comparing treatments A and B which are already in the existing trial network but do not have any direct comparison. The researchers' intention is to incorporate the result into an existing network for meta-analysis. Here we develop formulas to address these options and use simulations to validate our formula and evaluate the performance of different analysis methods in terms of power. We also implement our proposed method into the R package OssaNMA and publish an R Shiny app for the convenience of the application. The goal of the package is to enable researchers to readily adopt the proposed approach which can improve the power of an RCT and is therefore resource-saving. In the R Shiny app, We also provide the option to include the cost of each treatment which would enable researchers to compare the total treatment cost associated with each design and analysis approach. Further, we explore the effect of allocation to treatment group on study power when the a priori plan is to incorporate the new trial result into an existing network for meta-analysis.

Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation.

The high failure rate of industry-driven pediatric clinical trials leads to insufficient timely labeling of drugs in children and a lack of scientific evidence, resulting in the persistently high off-label drug use. National clinical trial networks can facilitate collaboration between sites, investigators, and experts, increasing the likelihood of successful trials. Within the conect4children (c4c) network, an Innovative Medicines Initiative 2-funded project, National Hubs hosted by National Clinical Trials Networks were set up across 21 European countries to facilitate the setup and execution of pediatric clinical trials. In this paper, we aim to present the performance metrics of the trial feasibility process as well as learnings and challenges encountered by the Belgian and Dutch Networks in working within the European c4c project. The c4c National Hubs streamline pediatric clinical trials by initiating early country outreach, identifying overlapping studies, recommending quality trial sites, and supporting trial budgeting for both industry and academic settings. To show the impact of Pedmed-NL and Belgian Pediatric Clinical Research Network (BPCRN), internal metrics were collected from 2019 to 2022 on four industry-sponsored and three academic trials performed within the c4c network. Timelines and outcomes of the site identification were collected and analyzed for industry trials. A qualitative analysis was conducted through c4c platforms, sponsor interactions, and stakeholder engagement to evaluate the added value of a research network. In industry-sponsored trials, full feasibility questionnaires were completed within 2 weeks (n = 48), and inclusion rates were up to 80% of clinical sites. Before committing to c4c, 14% of sites were contacted by industry, leading to communication burdens. Utilizing national infrastructure knowledge and therapeutic environment insights helped optimize trial timelines and address feasibility challenges. In addition, national adaptations, such as bilingual staff and site development, played a role in streamlining trial operations in both academic and industry settings. Performance and experiences were similar for both networks. The early-facilitation examples from the c4c trials demonstrated promising metrics for two National Hubs, including optimized start-up timelines and aiding site selection quality. The learnings and challenges of the Belgian and Dutch Networks provided insights for the development of clinical research networks.

Knowledge and awareness of clinical trials among trial participants in India: A multicentric questionnaire-based cross-sectional study.

The knowledge and attitude of participants toward clinical trials (CTs) are a key determinant in successful recruitment and retention. This study aimed to evaluate knowledge and awareness-attitude among the recruited CT participants about CTs. This was a cross-sectional face-to-face survey comprising CT participants involved in the past or currently a part of a CT during this study within the Indian Ophthalmology Clinical Trial Network (IOCTN). A previously validated questionnaire was used, and data regarding demographics, knowledge, and awareness-attitude about CTs were collected. The total awareness-attitude score was used to determine the knowledge and awareness of the participants. A total of 121 subjects had participated in the study who were part of ongoing trials, of which only five participants had prior experience of CTs. The majority (90%) had knowledge about CTs, whereas only 7% had confirmed signing consent forms. The total awareness-attitude score significantly varied across locations (27% for the southern zone, 53% for the central zone, and 52% for the western zone), and this was negatively associated with education. The most negative attitude (38.6%) was observed regarding adequate information sharing among participants, whereas non-disruption of their routine family life (60.7%) and financial stability (67.6%) were the top most positive attitudes revealed during their participation. The participants' pre- and post-participation attitude toward CTs revealed a positive attitude. The factors influencing a participant's knowledge and attitudes toward CTs were revealed in the study. Furthermore, the need for awareness regarding benefits of CTs to the public, participant's rights, and their voluntary power were the major highlights.

The development of the Belgian paediatric clinical trial network

ABSTRACT Paediatric clinical trials are critical to ensure that medications prescribed to children are safe and effective. However, evidence-based dosing and labelling of such medications remain limited, and most clinical trials in paediatrics fail. Factors for lack of trial completion include performance at site level (limited patient recruitment, limited site staff experience and lack of infrastructure), the sponsor team (limited paediatric specific expertise in design, uncertainties on robustness of biomarkers or outcome variables) as well as regulatory and administrative burdens. As a result of the growing demand for site support, the Belgian Paediatric Clinical Research Network (BPCRN) established in 2009 has been relaunched in 2018 to improve paediatric clinical trials, with the support of innovative-medicines-initiative 2 (IMI2) pan-European network conect4children (c4c) and the transatlantic network I-ACT for Children (US). This paper highlights the formation of the BPCRN and the practical insights it offers for advancing paediatric clinical trials through national networks. A national network can improve trial quality, safety and efficiency, provide clinical research expertise, identify suitable sites, and help with troubleshooting of common trial issues. The BPCRN’s centralized approach has advanced paediatric clinical trials by streamlining communication and standardizing trial conduct. Challenges and opportunities have arisen, including a relaunch in 2018, orphan medicine trials, and network sustainability. Collaboration between network activities, government support, site-level improvements, efficient communication, and interaction with industry are key to achieve lasting transformation in paediatric medicine research.

Engaging Underrepresented Patients in Hematology Clinical Trials through the LLS Impact (Influential Medicine Providing Access to Clinical Trials) Research Grant: A Multi-Institutional Effort

Introduction: Despite governmental and industry-sponsored efforts, clinical trial participation among rural residents and racial and ethnic minorities remains low. The NIH Revitalization Act of 1993 directed the NIH to establish guidelines for inclusion of women and minorities in clinical research. In 2015, the Food and Drug Administration launched an action plan to improve the quality of demographic subgroup data collection, identify barriers to enrollment, employ strategies to increase participation, and promote transparency of related data. However subsequent studies (Green et al. Health Aff. March 2022, Kanapuru et al. Blood Advances. March 2022.) showed no improvement in participation of racial minorities, including Blacks and Hispanics since this plan was enacted. Various complex system- and individual-based factors, including lack of clinical trial availability; lack of diversity in the investigator work force; scant patient and provider awareness of clinical trials; lack of trust in the health care system; and issues with access to care-often driven by financial, geographic, or social constraints (Allison et al. Cureus. Apr 2022.), and stringent eligibility criteria are deemed responsible. The Leukemia & Lymphoma Society (LLS) IMPACT (Influential Medicine Providing Access to Clinical Trials) research grant strives to bridge this unrelenting care gap. Methods: The LLS IMPACT program includes a 5-year research grant which was launched in 2021. The IMPACT grants support the establishment of clinical trial networks involving academic cancer centers (“Hubs”) linked to community clinics and oncology centers (“Spokes”). The program's overall goal is to provide patients access to trials through participation at the community sites. Initially, 3 institutional sites were selected to participate. These institutions had unique and tailored strategies to improve engagement of underrepresented patients, including black, indigenous, people of color, Hispanic, Latina/Latino, and people from rural communities in vastly different climates and local cultures. The IMPACT grant expanded to encompass 4 additional sites given the imminent needs and clamor of the hematology clinical trials community (Figure 1A). The catchment areas and strategies employed at each institution are summarized in the table (Figure 1B). Results: At the start of the grant period, focus was on building clinical research infrastructure and opening non-interventional clinical trials to teach personnel about clinical research and create relationships with patients. Other programs such as webinar series, tumor boards, technological advancements, and educational workshops were also established to enhance engagement among physicians, match patients to clinical trials, and to provide clinical trial education to potential patients. One trial that has seen early success is the CHIVE IMPACT trial, a non-interventional registry and biorepository which has enrolled 24 patients at a rural and underserved site as of July 2023. The purpose of CHIVE is to enroll patients who have clonal hematopoiesis (CH) or are at risk of CH and follow prospectively in efforts to understand risk of progression and potential for early intervention. The Universal Protocol is another biorepository trial which has more than tripled its enrollment number at a community site between 2021 and 2022. Of the 63 patients enrolled in 2022, 66% of them identified as a race other than White. As our core goal is to increase access to interventional trials, we hope to bring industry sponsored phase II and phase III studies to underrepresented areas that serve a broad patient population. Lack of financial resources, lack of transportation and distance to trial sites, and residual distrust of the medical community (e.g., legacy of Tuskegee experiments) are barriers the grantees are focused on overcoming to enroll the intended populations into clinical trials. Conclusion: The innovative strategies employed to expand access to clinical trials for underrepresented population at the various institutions through the LLS's IMPACT research grant can be utilized during clinical trials design and implementation phases to improve generalizability of clinical trials in hematologic malignancies. In the third year of this program, 7 participating sites are engaging impactful strategies (Figure 1B) which will be reported at the end of the grant period.

COVID mRNA Vaccination Responses in Individuals with Sickle Cell Disease: An ASH Research Collaborative Clinical Trial Network Study

A multi-state, long term follow-up study of individuals with sickle cell disease (SCD) demonstrated an increase in mortality and morbidity in children and adults with COVID. mRNA vaccines are recommended for all SCD patients. Vaccination in individuals with SCD for other infections may be associated with impaired antibody responses. Concern has also been raised about whether mRNA vaccines, through a unique mechanism, may induce disease-related-complications in patients with SCD resulting in a suboptimal immunization rate. The ASH Research Collaborative Clinical Trial Network (ASH RC CTN) performed a mRNA vaccine trial to assess whether antibody responses following COVID vaccination were adequate to induce immunity and whether mRNA vaccination precipitated any toxicity unique to SCD patients. We prospectively studied patients at 8 of the ASH RC CTN sites: Johns Hopkins, Prisma, Duke, UT Southwestern, Medical College of Wisconsin, UCSF, Children's National, and Montefiore. Eligible patients with SCD had not yet received the COVID vaccine. We enrolled 59 patients and 47 received at least one vaccination. All vaccinated patients received the monovalent Pfizer vaccine. Forty-two patients received two vaccinations and provided baseline blood samples prior to vaccination and 2 months after the initial vaccination. For this report, data for 41 paired samples were available for analysis of IgG reactivity against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. Samples were taken from 7 patients (17%) under 3 years of age, 17 (41%) from older children (3-17 years of age), and 17 (41%) from adults (18-53 years of age). The majority of patients had HbSS (73%) or HbSC (22%), and one of each had either HbS beta 0 (2%) or HbS beta+ (2%). Concurrent therapies included hydroxyurea (59%), voxelotor (17%), crizulizumab (2%), intravenous immunoglobulin (2%), and chronic transfusions (2%). Five had a history of splenectomy (12%). Seventy-five percent of patients received their initial vaccination within 10 days of the baseline visit, and the median time between initial vaccination and post vaccination blood draw was 62 days. One patient experienced a COVID infection 5 days after the baseline visit, but prior to vaccination. This individual later received two vaccinations and submitted blood samples for analysis. Post-vaccination fever/chills, arthralgias, emesis, or local vaccination pain/erythema were reported in 49% of the patients. None reported fever that required inpatient admission. Seven patients (17%) reported a total of 8 episodes of vaso-occlusive pain within 14 days of the 1st vaccination. Of these, three required evaluation and treatment at a medical facility, and one patient was admitted for inpatient care. Antibody responses are shown in the Figure. Fourteen patients (34%) were seronegative at baseline, all with IgG ≤ 0.48 arbitrary units (AU). Twenty-seven patients (66%) were seropositive at baseline with a median IgG = 4.59 AU. Post-vaccination demonstrated a median IgG = 32.2 AU for the initially seronegative patients, and IgG = 102 AU for those initially seropositive. All initially seronegative patients converted to seropositive post vaccination; although post-vaccination IgG levels were lower than in the patients who were initially seropositive (Wilcoxon rank sum test, p-value = 0.0062). Overall, patients with sickle cell disease had side effects similar to those in the general population, and patients with SCD also responded to the COVID mRNA vaccination as expected after 2 months. The 6-month titers will be analyzed in the early fall. To our knowledge, this is the largest mRNA vaccine efficacy and safety trial in individuals with SCD, and it also marks the first evaluation of vaccine safety and antibody response in very young children with SCD.

QLTI-09. INTEGRATION OF NEURO-ONCOLOGY CLINICAL PATHWAYS IN PROVIDENCE SOUTHERN CALIFORNIA CLINICAL RESEARCH NETWORK: UPDATED INFO AFTER 17 MONTHS OF UTILIZATION

Abstract INTRODUCTION ClinicalPath is an evidence-based oncology decision support and analytics tool for cancer care. ClinicalPath’s treatment recommendations are prioritized based on efficacy, toxicity, and cost, by a nationwide committee of oncologists. The pathways are updated quarterly with the most recent evidenced-based treatment options that healthcare providers choose for adoption to help standardize therapy, improve quality, and decrease cost. The pathway system also allows for local clinical trial mapping to promote clinical trial awareness and help increase enrollment. ClinicalPath provides clinical pathways delivering personalized, evidence-based oncology guidance at the point of care. ClinicalPath’s network in North America serves more than 2,000 cancer physicians, within 54 practices in 31 states (15 academic medical centers, 29 hospital systems, and 9 community practices). Population: Our population is derived from multiple hospitals in Southern California within the Providence Health System. Methodology: Medical oncologists and Advanced Practice Providers received training on ClinicalPath before go-live. ClinicalPath was integrated into the Epic EHR in multiple Southern CA hospitals in a single month in Jan 2022. RESULTS On reviewing the utilization data within our Southern California region from Jan 2022-May 2023, 2681 treatment decisions were made across all cancers, with 86.7% of cancer patients treated on pathway. Of these decisions, 114 were made within the neuro-oncology specialty, and 70.2% of those cancer patients were treated on pathway. CONCLUSION We successfully integrated and initiated ClinicalPath in a multiple hospital-affiliated community oncology clinical trial network which included a strong neuro-oncology presence. We are actively working across our Southern California Region to map locally available clinical trials to promote awareness and increase enrollment. Provider utilization and patient on-pathway rates are actively monitored and will be updated.

The impact of COVID-19 on sexual behavior, HIV prevention interest, general healthcare access, and other HIV risk factors among trial participants in Malawi, South Africa, Uganda, and Zimbabwe.

The COVID-19 pandemic greatly impacted HIV prevention and care globally. The pandemic also had disproportionate impacts on the financial, emotional, and physical wellbeing of women and girls in East and Southern Africa, who were already at increased HIV vulnerability. This study aimed to understand how the COVID-19 pandemic and its response efforts impacted the sexual behavior, HIV prevention interest, general healthcare access, and other HIV risk factors of women and girls in HIV prevention studies. Using the socio-ecological model (SEM), an explanatory sequential mixed-methods analysis was performed with data from four Microbicide Trial Network (MTN) studies on different populations-adolescent girls and young women (AGYW), pregnant persons, breastfeeding persons, and couples-in Malawi, South Africa, Uganda, and Zimbabwe. Descriptive statistics for outcomes of interest were calculated within each study separately and Chi-squared tests of independence were performed to evaluate associations between study population and outcomes. Excerpts from study qualitative interviews were stratified into code reports which were then summarized into memos with key themes and considerations of the SEM framework to provide context to quantitative findings. Few participants (8/731) had known or suspected COVID-19 infection. Sexual frequency and alcohol use decreased most often among AGYW compared to pregnant or breastfeeding women and couples (p-value < 0.001). The pandemic had little impact on changes in reported HIV prevention interest or access to HIV prevention study products. Healthcare access was impacted for everyone, with couples most likely to report decreases in access (p-value < 0.001). From qualitative interviews, economic instability, adverse mental health, and increased violence due to COVID-19 caused increased strain on other factors related to HIV vulnerability. While interest in HIV prevention did not change and a few HIV risks decreased for most women and girls, other vulnerabilities to HIV increased due to the COVID-19 pandemic, highlighting the importance of continued access to HIV prevention for women and girls. More research is needed to better understand the long-term impact of COVID-19 on HIV prevention and vulnerability in community populations.

Development, implementation, and dissemination of operational innovations across the trial innovation network.

Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.

1711P The DRUP-like clinical trials family: A distributed European trial network for equitable access to precision medicine

1711P The DRUP-like clinical trials family: A distributed European trial network for equitable access to precision medicine

Attitude and perception toward clinical trials in India among patients and patient bystanders visiting the Indian Ophthalmology Clinical Trial Network: A multi-centric, cross-sectional survey.

Advances in patient treatment depend heavily on clinical trials (CTs). Patient volunteers for CT are tougher to recruit and retain. In order to administer CTs effectively, it is necessary to comprehend how the public views and perceives participating in them. The study assessed the perception and attitudes of patients and bystanders toward CTs in India. This was a multi-centric, cross-sectional study among patients and bystanders using a questionnaire that consisted of socio-demographic characteristics and questions on knowledge and attitude toward participation in CTs. The minimum sample size estimated for the survey was 750. A total of 1260 respondents (patients and bystanders) had participated in the survey. 42% of total respondents were aware about CTs. Unawareness regarding (i) voluntary power of an individual to participate in a CT (only 47%), (ii) entitled benefits of free treatment and medical insurance during enrolment in a CT (only 47%), and (iii) only 16% of the respondents knew involvement of human subjects in CT were the major highlights among those who had prior knowledge about CTs. Education was the most pervasive factor in shaping positive perception among the respondents. Occupation was another ubiquitous factor in shaping their perception regarding CTs. The majority of respondents were not aware of CTs. The major concerns observed were time consumption and harmful nature of CTs that influenced their unwillingness to participate in CTs. Initiatives such as awareness campaigns and survey assessments that would result in scientifically effective health service policies would be strategic methods to enhance CT participation.

Commentary on 'Attitude and perception toward clinical trials in India among patients and patient bystanders visiting Indian ophthalmology clinical trial network: A multicentric, cross-sectional survey'.

Commentary on 'Attitude and perception toward clinical trials in India among patients and patient bystanders visiting Indian ophthalmology clinical trial network: A multicentric, cross-sectional survey'.

Research Staff COVID-19 Pandemic Survey-Results from the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network

Objectives: There is a lack of knowledge about the challenges of researchers who continued in-person research during the early phases of the COVID-19 pandemic. Design: Electronic survey assessing work-related exposure to COVID-19, logistical challenges, and procedural changes during the first year of the COVID-19 pandemic on clinical research. Setting: National Heart, Lung, and Blood Institute-sponsored Prevention and Early Treatment of Acute Lung Injury Clinical Trial Network Centers. Subjects: Research staff at research Network Sites. Measurements and Main Results: The 37-question survey was completed by 277 individuals from 24 states between 29 September 2020, and 12 December 2020, yielding a response rate of 37.7%. Most respondents (91.5%) indicated that non-COVID-19 research was affected by COVID-19 research studies. In response to the COVID-19 pandemic, 20% of respondents were reassigned to different roles at their institution. Many survey takers were exposed to COVID-19 (56%), with more than 50% of researchers requiring a COVID-19 test and 8% testing positive. The fear of infection was 2.7-times higher compared to pre-COVID-19 times. Shortages of personal protective equipment were encountered by 34% of respondents, primarily due to lack of access to N95 masks, followed by gowns and protective eyewear. Personal protective equipment reallocation from research to clinical use was reported by 31% of respondents. Most of the respondents (88.5%), despite these logistical challenges, indicated their willingness to enroll COVID-19 patients. Conclusions: During the first year of the COVID-19 pandemic, members of the research network were engaged in COVID-19 research despite logistical challenges, limited access to personal protective equipment, and fear of exposure. The research network’s survey experience can inform ongoing policy discussions to create research enterprises that can dexterously refocus research to address the knowledge gaps associated with novel public health emergencies while mitigating the effect of pandemics on existing research projects and research personnel.

Analyzing critical success factors for the implementation of air-taxi services for public transportation

PurposeCompanies are adopting innovative methods for responsiveness and efficiency in the public transport sector. The implementation of air-taxi services (ATS) in the transport sector is a move in this direction. Air taxis have a two-pronged advantage as they can reduce travel times by avoiding traffic congestion and have the potential to reduce carbon footprint compared to traditional modes of public transportation. Many companies worldwide are developing and testing ATS for practical applications. However, many factors may play a significant role in adopting ATS in the transport sector. This paper attempts to unearth such critical success factors (CSFs) and establish the interrelationships between these factors.Design/methodology/approachFifteen CSFs were identified by systematically reviewing the literature and taking experts' input. An integrated multi-criteria decision-making (MCDM) technique, Decision-Making Trial and Evaluation Laboratory-Analytic Network Process (DEMATEL-ANP [DANP]) was used to envisage the causal relationships between the identified CSF.FindingsThe results reveal that Govt Regulations (GOR), Skilled Workforce (SKF) and Conductive Research Environment (CRE) are the most influential factors that impact the adoption of ATS in the transport sector.Practical implicationsThe research implications of these findings will help practitioners and policymakers effectively implement ATS in the public transportation sector.Originality/valueThis is the first kind of study that identifies and explores the different CSFs for ATS implementation in public transportation. The CSFs are evaluated with the help of a framework built with inputs from logistics experts. The study recognizes the CSFs for ATS implementation and provides a foundation for future research and smooth adoption of ATS.

Analgesic effect of a lidocaine-ropivacaine mixture for extraction of impacted mandibular third molars: a randomized controlled trial.

The painless postoperative period can be significantly prolonged by using long-acting local anesthetics such as ropivacaine, though these local anesthetics are known for their slower onset of action. To compensate for this, a mixture of short-onset (e.g., lidocaine) and long-acting local anesthetics is used. However, the efficacy of such an anesthetic cocktail has not been elucidated in the field of oral and maxillofacial surgery. To address the research purpose, this prospective randomized controlled trial included 56 patients scheduled for impacted mandibular third molar extraction. All patients received the inferior alveolar nerve block (IANB) using either 2% lidocaine with epinephrine or a 1:1 mixture of 2% lidocaine with epinephrine and 0.75% ropivacaine. Patients anesthetized using the lidocaine-ropivacaine mixture showed significantly prolonged postoperative analgesia and pain control than those anesthetized using lidocaine only. IANB using a lidocaine-ropivacaine mixture can provide prolonged postoperative anesthesia and pain control with extraction of mandibular third molars. This method can be a noteworthy addition to existing methods of local anesthesia for the extraction of mandibular third molars. Trial registration number University Hospital Medical Information Network (No. UMIN000044315).

From HVTN to CoVPN: the importance of vaccine trial networks

From HVTN to CoVPN: the importance of vaccine trial networks