Cts-Clinical and Translational Science最新文献

{"title":"Predicting Vancomycin Clearance in Neonates and Infants by Integrating Machine Learning and Metabolomics With Population Pharmacokinetics","authors":"Hui Yu,&nbsp;Jingcheng Xiao,&nbsp;Hao-Jie Zhu","doi":"10.1111/cts.70293","DOIUrl":"10.1111/cts.70293","url":null,"abstract":"<p>The pharmacokinetics of vancomycin in neonates and infants exhibits significant variability, presenting challenges in achieving target exposures. This study aimed to investigate the influence of patient-specific covariates on vancomycin clearance and evaluate the predictive performance of various machine learning (ML) methods using clinical covariates and plasma metabolomics data. A retrospective population pharmacokinetic (PK) analysis was conducted on 42 neonates and infants treated at the University of Michigan Neonatal Intensive Care Unit from 2019 to 2022. Vancomycin was administered intravenously at doses ranging from 3.5 to 25 mg/kg every 6 to 24 h. A total of 214 vancomycin concentration measurements, including trough, peak, and random levels, were included in the analysis. Plasma samples collected from the patients were analyzed by an LC–MS/MS-based untargeted metabolomics assay. A one-compartment model with first-order elimination best described the pharmacokinetics of vancomycin, with serum creatinine (SCr), postmenstrual age (PMA), and weight identified as significant covariates influencing clearance. Among the ML methods evaluated, Gradient Boosting Regressor (GBR) achieved the highest predictive performance using clinical covariates (MSE: 0.0033; R²: 0.830). Incorporating metabolomics data did not significantly improve predictive performance for most models based solely on clinical covariates, although certain metabolomics features were among the top predictors. Both PK modeling and ML identified SCr and PMA as the most important covariates. These findings highlight the utility of ensemble ML methods, particularly GBR, in predicting vancomycin clearance using clinical covariates. While metabolomics provided limited added value for vancomycin clearance prediction, this study demonstrated an integrated ML and metabolomics approach capable of exploring PK variability in drugs with complex metabolic pathways.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70293","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144563076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics of Belumosudil and Its Metabolites in Individuals With Hepatic Impairment","authors":"Olivier Schueller,&nbsp;Virginie Esposito,&nbsp;Lauren Lohmer,&nbsp;Felix Beck,&nbsp;Lenore Teichert,&nbsp;Jeegar Patel,&nbsp;Jasminder Sahi","doi":"10.1111/cts.70265","DOIUrl":"10.1111/cts.70265","url":null,"abstract":"<p>Belumosudil, an orally administered Rho-associated coiled-coil–containing protein kinase 2 selective inhibitor drug for treatment of chronic graft-versus-host disease (GVHD), is predominantly eliminated via the liver. This phase 1, open-label, non-randomized, parallel-group study (NCT04166942) evaluated belumosudil pharmacokinetics and safety after a single 200-mg dose in participants with mild, moderate, or severe hepatic impairment (Child-Pugh classification), matched with healthy participants with normal hepatic function. M1 and M2 metabolites were also assessed. Geometric least squares mean (GLSM) ratios (90% confidence intervals [CI]) for belumosudil area under the plasma concentration-time curve (AUC) from time 0 to the time to infinity (AUC_0-∞), AUC to the time of last measurable concentration (AUC_0−<i>t</i>), and maximum concentration (<i>C</i>_max) were 1.36 (0.83–2.21), 1.48 (0.96–2.28), and 1.20 (0.91–1.58), respectively, for the mild impairment group, and 1.51 (0.98–2.33), 1.50 (0.97–2.31), and 0.94 (0.60–1.48), respectively, for the moderate impairment group. Severe hepatic impairment markedly increased belumosudil AUC_0–∞ and AUC_0–<i>t</i> but had no apparent effect on <i>C</i>_max; GLSM ratios (90% CI) were 4.21 (2.20–8.06), 3.23 (1.53–6.81), and 1.32 (0.90–1.96), respectively. A post hoc analysis was conducted using the National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) classification for hepatic impairment. Assessment by NCI-ODWG criteria, compared with Child-Pugh criteria, revealed a higher range of exposure in participants with moderate hepatic impairment. Belumosudil can be taken by patients with mild hepatic impairment without dose adjustment; avoid use in patients with moderate hepatic impairment (Child-Pugh B) or severe hepatic impairment (Child-Pugh C) without liver GVHD.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70265","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144558217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-Frequency, At-Home Monitoring of Drug Safety and Tolerability in Clinical Trials: Results From Studies of Fluvoxamine for COVID-19 Treatment","authors":"Eric J. Lenze,&nbsp;Madeline Nykamp,&nbsp;J. Philip Miller,&nbsp;Angela Stevens,&nbsp;Julia Schweiger,&nbsp;Torie Gettinger,&nbsp;Michael Yingling,&nbsp;Yi Zhang,&nbsp;Ginger E. Nicol,&nbsp;Charles F. Zorumski,&nbsp;Angela M. Reiersen","doi":"10.1111/cts.70292","DOIUrl":"10.1111/cts.70292","url":null,"abstract":"<p>Clinical trials are increasingly using remote monitoring techniques at the patient's home. We conducted a secondary analysis of remote safety and tolerability monitoring from two fully-remote clinical trials that tested fluvoxamine for the acute treatment of COVID-19. Both trials assessed pulse and blood pressure daily, and one study assessed symptoms daily via Ecological Momentary Assessment. On average, patients provided data on vital signs on 93% of the study days and provided data on side effects on 81% of the study days. With respect to safety, patients taking fluvoxamine had reduced pulse rate compared to placebo, with the greatest difference—5 points—at treatment Day 4. In contrast, fluvoxamine showed little to no effect on blood pressure. With respect to tolerability, nausea was most frequent in the first 4–5 days, declining significantly thereafter, while anxiety and difficulty concentrating were uncommon with fluvoxamine compared to placebo. These findings show that remote assessment of safety and tolerability is feasible in clinical trials, and that frequent assessments can provide in-depth data on the timecourse of safety or tolerability signals.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70292","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144551120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantifying Sample Representation in Global Pharmacogenomic Studies of Major Depressive Disorder: A Systematic Review","authors":"Linsey Jackson,&nbsp;Karina Delaney,&nbsp;Justin Bobo,&nbsp;Caroline W. Grant,&nbsp;Leslie Hassett,&nbsp;Liewei Wang,&nbsp;Richard Weinshilboum,&nbsp;Paul E. Croarkin,&nbsp;Ann Moyer,&nbsp;Melanie T. Gentry,&nbsp;Arjun P. Athreya","doi":"10.1111/cts.70256","DOIUrl":"10.1111/cts.70256","url":null,"abstract":"<p>Major depressive disorder (MDD) is a substantial public health challenge. Pharmacogenomics (PGx), which identifies genetic variations that predict drug treatment outcomes, may have utility for clinical practice, but adequate representation of all populations is needed. As precision medicine in psychiatry moves towards the use of Artificial Intelligence (AI) and Machine Learning (ML) to predict treatment outcomes using PGx data, representation of diverse populations will be especially important in order to mitigate algorithmic bias and achieve equitable and generalizable findings. This work sought to quantify population diversity in pharmacogenomic studies of MDD through a systematic review. Data from 390 MDD antidepressant PGx studies were extracted from 5739 articles screened. Studies summarized were predominantly conducted in Europe, East Asia, and North America. Across all global studies, the study population comprised 57.3% White, 36.4% Asian, 1.7% Black, 3.5% Hispanic/Latino, and 0.1% Native American or Indigenous participants. Only sixty-three (16.2%) studies included Black or Latino/Hispanic patients. Additionally, Black, Asian, Hispanic/Latino, and American Indian/Alaska Native populations were statistically underrepresented in U.S. study populations when compared to national census data, while Asian and Black populations were underrepresented in the United Kingdom. The overrepresentation of participants from a limited number of countries combined with the underrepresentation of Black and Hispanic/Latino populations could impact the extent to which pharmacogenomic testing and associated AI/ML-based PGx tools could individualize antidepressant medication regimens for treating MDD.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70256","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144551247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methods of Estimating Plasma Pharmacokinetics From Minimally Invasive, High Temporal Resolution Measurements of Interstitial Fluid Drug Concentrations","authors":"Murat K. Erdal,&nbsp;Tod E. Kippin,&nbsp;João P. Hespanha,&nbsp;Kevin W. Plaxco","doi":"10.1111/cts.70248","DOIUrl":"10.1111/cts.70248","url":null,"abstract":"<p>In therapeutic drug monitoring, plasma drug concentrations are used to guide dosing decisions, significantly improving outcomes for many therapeutic interventions. Due to the cumbersome, laboratory-based approaches used to measure such drug concentrations, however, such monitoring is slow to return actionable information to the clinician and is performed far less frequently than would be optimal. In response, approaches are being developed by which in vivo drug concentrations can be monitored in real time and at high frequency in the subcutaneous or intradermal interstitial fluid—measurements that are safe, convenient, and minimally invasive. In the furtherance of this approach, here, we explore theoretically the ability to use such high-frequency sub- or intradermal measurements to estimate the corresponding plasma concentration–time courses, as the latter remain the basis of effectively all clinical decision making. Doing so, we find that, given various physiologically and technologically plausible assumptions, it is possible to accurately estimate plasma concentration–time courses from measurements of interstitial fluid taken at two nonredundant sites in the interstitial fluid. This ability to derive clinically important plasma pharmacokinetics using minimally invasive subcutaneous or intradermal sensor placements has the potential to significantly improve the precision and reach of therapeutic drug monitoring and, with that, the safety and efficacy of drug delivery.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70248","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144537077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance on Dexamethasone 1 mg/mL + Levofloxacin 5 mg/mL Eye Drops, Solution: A Five-Year Registry","authors":"Giorgio Ciprandi,&nbsp;Alice Omini,&nbsp;Danila Lo Sicco,&nbsp;Lucia Cutuli,&nbsp;Alessandro Colombo,&nbsp;Gregorio Lo Giudice","doi":"10.1111/cts.70275","DOIUrl":"10.1111/cts.70275","url":null,"abstract":"<p>Cataract surgery is a common procedure requiring post-surgical pharmacological treatment to dampen inflammation and prevent infections. In 2020, a fixed eye drops combination of dexamethasone 1 mg/mL + levofloxacin 5 mg/mL for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults was approved. This innovative combination ensures the control of inflammation and prevents infection in a one-week course, preventing antibiotic resistance and minimizing steroid adverse events. This study aimed to collect information on reported suspected Adverse Drug Reactions (ADRs) of this product and analyze their characteristics in various System Organ Classifications. Using the European database of suspect ADRs as an access tool, we extracted line listings of reported ADRs that occurred using levofloxacin/dexamethasone from 2020 to 2024. The product has been approved in almost sixty countries worldwide, and approximately 4 million patients have been treated. A total of 53 ADRs concerning 25 patients were retrieved: 39 ADRs were not serious, while 14 ADRs were serious; 27 ADRs (51%) were evaluated as unlikely related to the drug. Eye and skin were the most common systems involved. Moreover, 15 special situations have been registered, mostly off-label use (10; 67%). Interestingly, levofloxacin/dexamethasone was not associated with confirmed endophthalmitis occurrence, one of the most serious ophthalmic emergencies. Based on data collected, no relevant safety issues have been identified that would alter the product's safety and efficacy profile. A large proportion of these ADRs were non-serious and unlikely to be related to the product or special situations.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70275","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144536848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Population PK and Exposure-Response Analyses of Zolbetuximab in Patients With Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma","authors":"Akihiro Yamada,&nbsp;Masato Takeuchi,&nbsp;Kanji Komatsu,&nbsp;Peter L. Bonate,&nbsp;Srinivasu Poondru,&nbsp;Jianning Yang","doi":"10.1111/cts.70280","DOIUrl":"10.1111/cts.70280","url":null,"abstract":"<p>Zolbetuximab is a chimeric (mouse/human) monoclonal antibody directed against the tight junction protein claudin 18.2, which is highly expressed in gastric/gastroesophageal junction (G/GEJ) and pancreatic adenocarcinoma. We report a population pharmacokinetic (PK) and exposure-response (E-R) analysis of zolbetuximab in patients with locally advanced unresectable or metastatic G/GEJ adenocarcinoma. A population PK model for zolbetuximab was developed using data from eight clinical studies to generate exposure metrics for safety/efficacy E-R analyses of three trials. A two-compartment model with zero-order input and time-dependent clearance adequately characterized zolbetuximab serum concentration-time data. Estimated mean clearance at baseline, steady-state clearance, steady-state volume of distribution, and elimination half-life were 0.0276 L/h, 0.0117 L/h, 5.53 L, and 7.56–15.2 days, respectively. Time required for trough concentration to reach steady state was 24 weeks. Mild hepatic or mild/moderate renal impairment did not alter zolbetuximab PK. Gastrectomy increased average zolbetuximab concentration (30%), trough concentration (first dose, 114%; steady state, 50%), and area under the concentration-time curve (26%–34%), but maximum concentrations were similar (gastrectomy vs. no gastrectomy) and no clinical relevance is anticipated. Multivariable Cox proportional hazard modeling indicated statistically significant relationships between average zolbetuximab concentration and progression-free survival and overall survival (both <i>p</i> &lt; 0.0001) after controlling for other relevant covariates. Maximum concentration after the first dose was significantly associated with gastrointestinal adverse events and infusion-related reactions. The phase 3 zolbetuximab regimen of 800/600 mg/m² every 3 weeks was supported by efficacy/safety data; an alternative regimen of 800/400 mg/m² every 2 weeks was predicted to have similar efficacy/safety.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70280","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144537180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of HSK39297 in Chinese Healthy Subjects: A Phase 1 Clinical Trial","authors":"Yuyang Dai,&nbsp;Feng Wu,&nbsp;Siyang Ni,&nbsp;Xiaojun Hu,&nbsp;Ying Han,&nbsp;Ying Jiao,&nbsp;Huan Lu,&nbsp;Yilin Liu,&nbsp;Lingling Wang,&nbsp;Yunfei Lin,&nbsp;Meixia Chen,&nbsp;Chao Wang,&nbsp;Qinghe Wu,&nbsp;Fangqiong Li,&nbsp;Laichun Lu","doi":"10.1111/cts.70281","DOIUrl":"10.1111/cts.70281","url":null,"abstract":"<p>HSK39297 is a novel complement factor B inhibitor, and this phase 1 trial was designed to assess its pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability in healthy Chinese subjects. This study included 46 subjects in the single ascending dose (SAD) part (50–600 mg) and 50 subjects in the multiple ascending dose (MAD) part (50–125 mg BID and 200–300 mg QD). Among them, a food effect study was conducted in the SAD 200 mg group. Adverse events (AEs) reported after the initial dose of the study drug were considered treatment-emergent AEs (TEAEs). Blood samples were collected to measure plasma concentrations of HSK39297 at predefined time points and analyzed at a centralized laboratory. In addition, PD analysis was conducted by measuring complement alternative pathway (AP) activity and Bb concentrations. According to the results, we found single and multiple doses of HSK39297 were safe and well tolerated in all subjects. Within SAD of 50–600 mg dose range, the <i>C</i>_max, AUC_0-<i>t</i>, and AUC_0-∞ exhibited nonlinear PK characteristics. The high-fat meals did not significantly affect the absorption rate and systemic exposure levels of HSK39297, and GMRs for fed versus fasting states were 108.05% (99.66%, 117.15%), 98.73% (89.34%, 109.09%), and 97.86% (84.66%, 113.11%), respectively. In MAD part, dose-drug exposure showed a linear relationship. PD analysis indicated that oral administration of HSK39297 tablets resulted in dose-dependent inhibition of the AP activity and Bb concentration. These findings support advancing HSK39297 into later-phase trials for complement-mediated glomerular diseases.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70281","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144536799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dosage Regimen Optimization of Ertapenem Against ESBL-Producing Enterobacterales Infection in Critically Ill Patients Using Monte Carlo Simulation","authors":"Apirat Muangkasem,&nbsp;Wichit Nosoongnoen,&nbsp;Suthida Sririttha,&nbsp;Teerapong Aramruang,&nbsp;Preecha Montakantikul","doi":"10.1111/cts.70274","DOIUrl":"10.1111/cts.70274","url":null,"abstract":"<p>Extended-spectrum beta-lactamase (ESBL)-producing <i>Enterobacterales</i> infections are associated with high mortality rates. Ertapenem is recommended as one of the first-line drugs due to its efficacy against these pathogens. However, physiological changes in critically ill patients may influence drug pharmacokinetics. Thus, this study aims to optimize the ertapenem dosage regimen for critically ill patients in both efficacy and neurotoxicity. The previously reported population pharmacokinetic model and drug-albumin binding model were used for Monte Carlo simulation. A total of 10 ertapenem dosage regimens were performed in 10,000 simulated critically ill patients with varying degrees of renal function and serum albumin. A PTA of achieving 100% for time of free drug above the minimum inhibitory concentration (<i>f</i>T&gt;MIC) was assessed for efficacy. A PTA of achieving a total drug ≥ 11.77 mg/L was determined for neurotoxicity. A usual recommended dosing of 1 g every 24 h can ensure a PTA &gt; 80% for efficacy only in patients having a creatinine clearance of 30–59 mL/min with unlikely neurotoxic risk (a PTA &lt; 2%). Moreover, the study highlights the need for an individualized ertapenem dosage regimen based on renal function in critically ill patients, as ertapenem in divided doses might be more optimal for both efficacy and safety compared to once daily dosing in patients with creatinine clearance ≥ 60 mL/min. Further randomized controlled trials are needed to confirm these dose recommendations.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70274","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144525018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Survey Study of Roadblocks in Translational Science","authors":"Fasiha Kanwal,&nbsp;Christopher I. Amos,&nbsp;Katherine H. Sippel,&nbsp;Claudia Neuhauser,&nbsp;Ariel Harrison,&nbsp;Mary E. Dickinson,&nbsp;Charles Minard,&nbsp;Bettina M. Beech","doi":"10.1111/cts.70259","DOIUrl":"10.1111/cts.70259","url":null,"abstract":"<p>Clinical and translational science needs to address roadblocks to the translational processes. We conducted a survey at two institutions, a private medical school and a large public university, to understand the frequency and distribution of barriers and roadblocks to research. We reviewed the literature to compile a pool of barriers and roadblocks and convened a panel of relevant stakeholders to develop a 20-item questionnaire. Survey respondents were asked to select and prioritize the five leading clinical and translational roadblocks, provide information regarding their academic degrees and rank/position, complete open-ended items regarding their areas of research, and optionally add additional remarks in a comment box. The survey was disseminated in August 2022 to faculty and staff with active research protocols at Baylor College of Medicine and the University of Houston. In total, 227 respondents completed the survey. Their disciplines were basic science (29.5%), translational research (52.9%), clinical research (55.5%), community-engaged research (9.7%), and educational research (9.7%). Respondents identified (1) lack of access to trained research coordinators, (2) lack of understanding about different resources that facilitate research, (3) complex regulatory environment and delays, (4) fragmented infrastructure for administrative and fiscal processes, and (5) inadequate funding for pilot projects to foster new research. Other roadblocks included lack of established community stakeholder partnerships, inadequate access to medical record data, and limited biostatistical support. We identified leading roadblocks to research from the perspectives of scientists and staff conducting clinical and translational research. Operational innovations addressing these roadblocks can accelerate the pace of translation.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 7","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70259","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144503231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}