Cts-Clinical and Translational Science最新文献

{"title":"CYP2C19-Guided Voriconazole Therapy: A Precision Medicine Approach to Mitigate Adverse Effects in Japanese Patients","authors":"Yoshiki Katada,&nbsp;Daiki Hira,&nbsp;Keisuke Umemura,&nbsp;Yurie Katsube,&nbsp;Hiroki Ishimura,&nbsp;Yusuke Kojima,&nbsp;Machiko Hirai,&nbsp;Moto Kajiwara,&nbsp;Mitsuhiro Sugimoto,&nbsp;Hiroki Endo,&nbsp;Junru Cao,&nbsp;Saki Ohta,&nbsp;Kinuka Kotani,&nbsp;Sakiko Hatazoe,&nbsp;Masahiro Tsuda,&nbsp;Shunsaku Nakagawa,&nbsp;Koh Shinohara,&nbsp;Yasuhiro Tsuchido,&nbsp;Miki Nagao,&nbsp;Tomohiro Terada","doi":"10.1111/cts.70317","DOIUrl":"10.1111/cts.70317","url":null,"abstract":"<p>Voriconazole (VRCZ) is a triazole antifungal agent with a broad antifungal spectrum. It is metabolized by hepatic cytochrome P450 (CYP) isozyme CYP2C19, whose genetic polymorphism causes significant variability in drug efficacy and safety. Poor metabolizer alleles of <i>CYP2C19</i> are more common in Asian populations, increasing the risk of supratherapeutic VRCZ levels. We have developed a novel nomogram based on <i>CYP2C19</i> genetic polymorphisms. This study aimed to evaluate whether <i>CYP2C19</i> genotype-guided VRCZ therapy reduces toxicity in Japanese patients. This retrospective study included 64 patients (genotype-guided group, <i>n</i> = 26; comparison group, <i>n</i> = 38). The primary outcome was defined as the composite incidence of adverse events commonly observed with VRCZ, represented by the combined occurrence of grade ≥ 2 hepatotoxicity and visual symptoms. Secondary outcomes included the proportion of patients maintaining VRCZ trough concentrations within the therapeutic range (1–4 μg/mL) and the treatment response at 28 days. The composite incidence of adverse events was significantly lower in the genotype-guided group than in the comparison group (<i>p</i> = 0.003). VRCZ discontinuation due to adverse events occurred in nine patients (23.7%) in the comparison group and one (3.8%) in the genotype-guided group (<i>p</i> = 0.039). More patients in the genotype-guided group were achieved through concentrations within the therapeutic range at the initial sampling point. However, treatment response rates did not differ significantly between the groups. VRCZ administration based on <i>CYP2C19</i> genotyping improved therapeutic trough levels management and reduced adverse effects while maintaining therapeutic efficacy. These findings highlight the importance of <i>CYP2C19</i> genotyping for VRCZ treatment in Japanese patients.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70317","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144869316","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":"Cardiotoxicity Assessment of EGFR Tyrosine Kinase Inhibitors Using Human iPS Cell-Derived Cardiomyocytes and FDA Adverse Events Reporting System","authors":"Shota Yanagida,&nbsp;Hiroyuki Kawagishi,&nbsp;Mitsuo Saito,&nbsp;Hirofumi Hamano,&nbsp;Yoshito Zamami,&nbsp;Yasunari Kanda","doi":"10.1111/cts.70325","DOIUrl":"10.1111/cts.70325","url":null,"abstract":"<p>Recent advances in the development of anti-cancer drugs have contributed to prolonged survival of cancer patients. In contrast, drug-induced cardiotoxicity, particularly cardiac contractile dysfunction, is of growing concern in cancer treatment. Therefore, it is important to understand the risks of anti-cancer drug-induced cardiac contractile dysfunction in drug development. We have previously developed image-based motion analysis using human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) to assess the effect of drugs on contractility. However, the utility and predictive potential of image-based motion analysis using hiPSC-CMs for anti-cancer drug-induced cardiac contractile dysfunction have not been well understood. Here we focused on epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) and investigated the correlation between the hiPSC-CMs data and clinical signals of adverse events related to cardiac contractile dysfunction. We examined the effects of the four EGFR-TKIs, osimertinib, gefitinib, afatinib, and erlotinib, on the contractility of hiPSC-CMs using image-based motion analysis. We found that osimertinib decreased contraction velocity and deformation distance in a dose- and time-dependent manner, whereas gefitinib, afatinib, and erlotinib had little effect on these parameters. Next, we examined the real-world data of the EGFR-TKIs using FDA Adverse Event Reporting System (FAERS; JAPIC AERS). Only osimertinib showed significant clinical signals of adverse events related to cardiac contractile dysfunction. These data suggest that hiPSC-CM data correlate with clinical signals in FAERS analysis for four EGFR-TKIs. Thus, image-based motion analysis using hiPSC-CMs can be a useful platform for predicting the risk of anti-cancer drug-induced cardiac contractile dysfunction in patients.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70325","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144861723","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":"Mirikizumab Pharmacokinetics and Exposure-Response in Patients With Moderately-To-Severely Active Crohn's Disease: Results From Two Randomized Studies","authors":"Laiyi Chua,&nbsp;Yuki Otani,&nbsp;Zhantao Lin,&nbsp;Stuart Friedrich,&nbsp;Frederick Durand,&nbsp;Xin Cindy Zhang","doi":"10.1111/cts.70320","DOIUrl":"10.1111/cts.70320","url":null,"abstract":"<p>Mirikizumab is a humanized anti–interleukin-23-p19 monoclonal antibody approved for both moderately-to-severely active ulcerative colitis and moderately-to-severely active Crohn's disease (CD). We characterized pharmacokinetics (PK) and exposure-response (ER) of mirikizumab in relation to efficacy and safety in CD using data from randomized phase 2 SERENITY (NCT02891226) and phase 3 VIVID-1 (NCT03926130) trials. Patients received 12-week mirikizumab induction (200, 600, or 1000 mg [SERENITY] or 900 mg [VIVID-1] intravenously [IV]) or placebo, every 4 weeks (Q4W), then maintenance (200, 600, or 1000 mg IV [SERENITY], 300 mg subcutaneously (SC) [SERENITY and VIVID-1], or placebo, Q4W) to Week 52. PK and ER for efficacy were analyzed using population PK and logistic regression models for Weeks 12 and 52 endpoints, respectively, and included analyses of covariate effects. Mirikizumab PK was best described by a two-compartment model, with first-order absorption for SC maintenance doses. Body weight, body mass index, serum albumin concentration, C-reactive protein, and disease severity had statistically significant effects on PK, while body weight and disease severity affected ER; these effects were not considered clinically relevant. Efficacy results of 900 mg mirikizumab in VIVID-1 aligned with SERENITY, which observed near-maximal efficacy at Week 12 with 600–1000 mg mirikizumab IV. Efficacy at Week 52 did not vary markedly with exposure during maintenance. There was no significant association between exposure and adverse events. These results support the selection of 900 mg mirikizumab IV Q4W for induction and 300 mg SC Q4W for maintenance in patients with CD, with no dose adjustment for patient factors required.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70320","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144833225","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":"Recommendations for (Pharmaco)Genetic Sampling in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation","authors":"Anniek Bokma,&nbsp;Maja Matic,&nbsp;Arwin Ralf,&nbsp;Bianca J. C. van den Bosch,&nbsp;Manfred Kayser,&nbsp;Ron H. N. van Schaik,&nbsp;Melvin Lafeber,&nbsp;Marieke J. H. Coenen,&nbsp;Florence Atrafi","doi":"10.1111/cts.70303","DOIUrl":"10.1111/cts.70303","url":null,"abstract":"<p>In patients receiving allogenic hematopoietic stem cell transplantation (aHSCT) complete chimerism is desired. However, this brings a challenge when non-invasive assessment of recipient germline DNA is required for genetic testing. Here, we aim to create awareness for (pharmaco)genetic sampling in patients following aHSCT based on a case report of a patient following aHSCT in which pharmacogenetic analysis was performed. Six pharmacogenetic genes were analyzed in DNA extracted from peripheral blood (pre- and post-transplant), buccal swab, and hair follicles. To investigate the presence of donor DNA in post-transplant samples, short tandem repeat and digital droplet PCR analysis were performed. DNA from post-transplantation peripheral blood and the buccal swab showed identical genotypes: <i>CYP2C9</i>*1/*1, <i>CYP2C19</i>*1/*2, <i>CYP2D6</i>*2/*9, <i>CYP3A4</i>*1/*1, <i>VKORC1</i>-1639TT, <i>SLCO1B1</i>*1/*5. Pre-transplant DNA showed different genotypes for CYP2D6 (*1/*2) and SLCO1B1 (*1/*1). Due to the low DNA amount extracted from hair follicles, only <i>CYP2D6</i> and <i>SLCO1B1</i> were examined, showing identical genotypes to pre-transplantation DNA. Short tandem repeat analysis showed that the buccal swab contained DNA from both donor and recipient. It was estimated that the buccal swab contained ~63% donor DNA, while DNA from hair follicles showed 0% donor DNA. In conclusion, pharmacogenetic profiling after allogenic HSCT should be done with consideration. Analysis of pre-transplant peripheral blood is preferred over buccal swab due to the presence of donor DNA contamination. DNA extracted from hair is also a reliable source; however, application might be restricted due to limited DNA yield.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70303","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144832653","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":"Continuation Versus Discontinuation of Sodium-Glucose Cotransporter-2 Inhibitors and Cardiorenal Outcomes Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A Nationwide Cohort Study With a Target Trial Emulation Framework","authors":"Yaa-Hui Dong,&nbsp;Chia-Hsuin Chang,&nbsp;Li-Chiu Wu,&nbsp;Sengwee Toh","doi":"10.1111/cts.70319","DOIUrl":"10.1111/cts.70319","url":null,"abstract":"<p>Clinical guidelines recommend continuation of sodium-glucose cotransporter-2 inhibitor (SGLT2i) treatment when renal function deteriorates among patients with type 2 diabetes. However, the recommendation is not currently supported by research specifically designed to compare continuation versus discontinuation of SGLT2is for patients who have received the treatment for a while before experiencing renal function deterioration. Using linked Taiwanese databases with claims and clinical data and a target trial emulation framework, we conducted a nationwide cohort study to investigate the association between SGLT2i continuation and major cardiorenal outcomes after renal function declined. We identified patients with type 2 diabetes who received SGLT2is during 2016–2020, who either continued or discontinued SGLT2is within 180 days after their eGFR declined below 45 mL/min/1.73 m². The study outcomes were myocardial infarction, stroke, heart failure, acute kidney injury, and all-cause mortality. We estimated the on-treatment and intention-to-treat hazard ratios (HRs) and 95% confidence intervals (CIs) comparing SGLT2i continuation versus SGLT2i discontinuation, adjusting for baseline and time-varying covariates using inverse probability weighting. Among 11,467 eligible patients, the on-treatment HR associated with SGLT2i continuation was 0.83 (95% CI, 0.59–1.18) for myocardial infarction, 0.74 (0.56–0.95) for stroke, 0.58 (0.49–0.69) for heart failure, 0.53 (0.45–0.63) for acute kidney injury, and 0.51 (0.42–0.61) for all-cause mortality. The results did not change meaningfully in the intention-to-treat analysis or within pre-specified patient subgroups, including patients with eGFR below 30 mL/min/1.73 m² or prior acute kidney injury. Our findings provide scientific evidence to support continuing SGLT2i use when renal function declines during the SGLT2i treatment course.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70319","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144814772","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":"Correction to Effect of Vitamin D Supplementation on Circulating Level of Autophagosome Protein LC3A, Inflammation, and Physical Performance in Knee Osteoarthritis","authors":"","doi":"10.1111/cts.70324","DOIUrl":"10.1111/cts.70324","url":null,"abstract":"<p>Saengsiwaritt W, Jittikoon J, Chaikledkaew U, Tawonsawatruk T, Honsawek S, Udomsinprasert W, “Effect of Vitamin D Supplementation on Circulating Level of Autophagosome Protein LC3A, Inflammation, and Physical Performance in Knee Osteoarthritis,” Clinical and Translational Science, 2023 16(12):2543–2556. doi: 10.1111/cts.13646.</p><p>In the funding information section, the funding sources were incorrectly stated as:</p><p>“This work was supported by the National Research Council of Thailand (NRCT; N42A650217) and the Royal Golden Jubilee (RGJ) PhD Programme Year 2020 (NRCT5-RGJ63012-145).”</p><p>The correct acknowledgment should read:</p><p>“This research project is supported by National Research Council of Thailand (NRCT): NRCT5-RGJ63012-145 and Grant N42A650217.”</p><p>We apologize for this error.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70324","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144809219","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":"Knowledge and Views of Patients With Cardiovascular Disease Toward Pharmacogenomics in The United Arab Emirates","authors":"Maram O. Abbas,&nbsp;Azhar T. Rahma,&nbsp;Iffat Elbarazi,&nbsp;Bassam R. Ali,&nbsp;George P. Patrinos,&nbsp;Farah Nagy,&nbsp;Alya Osman,&nbsp;Reem K. Alneyadi,&nbsp;Anwar S. Alshamsi,&nbsp;Mohamed Alraqabani,&nbsp;Zeina Al-Mahayri,&nbsp;Fatma Al-Maskari","doi":"10.1111/cts.70300","DOIUrl":"10.1111/cts.70300","url":null,"abstract":"<p>Pharmacogenomics (PGx) can potentially tailor medication prescriptions to the genetic profiles of individuals, enhancing treatment outcomes and minimizing adverse drug reactions. This study assessed cardiovascular disease (CVD) patients' knowledge and views toward PGx testing in the United Arab Emirates (UAE). A cross-sectional study was conducted among CVD patients attending multiple clinics using a validated, culturally adapted, and piloted bilingual questionnaire. Participants were invited via phone calls or in-person contact at clinics. Data analysis was conducted using SPSS V.29, incorporating descriptive statistics and multivariable logistic regression. A total of 425 responses were analyzed; 67.5% were over 50 years old, and 67.5% held a bachelor's degree. Chronic diseases, excluding CVD, affected 65.2%, with 58.1% reporting medication side effects and 36.5% was hospitalized due to these effects. Knowledge varied, with 55.3% demonstrating good knowledge; 75.3% recognized DNA as gene-based, while 47.5% understood PGx for predicting medication responses. Participants were grouped into three PGx perception clusters: Cluster 1 (33.17%) concerned about risks but valued PGx, Cluster 2 (40.23%) worried about privacy/costs, and Cluster 3 (26.58%) confident in PGx benefits. Safety was the top priority for 60.2% of respondents, 34.8% would not pay for PGx tets, and 35.3% preferred preemptive testing. Regression linked higher PGx knowledge to females, non-healthcare workers, those with genetic diseases, and those hospitalized for side effects (<i>p</i> &lt; 0.05). The study highlights a need for educational initiatives in the UAE to improve PGx literacy among CVD patients. The findings suggest that targeted awareness campaigns, policy interventions addressing privacy, and financial support could promote PGx wider adoption.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70300","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144814539","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":"First-In-Human, Randomized, Placebo-Controlled, SAD and MAD Trial to Evaluate Safety, Tolerability, and PK/PD Modeling of Potravitug in Healthy Adults","authors":"Marcus May,&nbsp;Julia K. Bialek-Waldmann,&nbsp;Andrew Wright,&nbsp;Scott Gruver,&nbsp;Joshuaine Grant,&nbsp;Barbara Eicher,&nbsp;Jemima Seidenberg,&nbsp;Gerald P. Parzmair,&nbsp;Juergen Beck","doi":"10.1111/cts.70316","DOIUrl":"10.1111/cts.70316","url":null,"abstract":"<p>BK polyomavirus (BKPyV) affects 10%–30% of kidney-transplant recipients receiving immunosuppressive therapy, potentially leading to nephropathy, graft dysfunction, graft loss, and increased mortality. Despite the medical need, no targeted therapies exist. This first-in-human trial evaluated the safety, tolerability, pharmacokinetics, and immunogenicity of potravitug, a novel fully human antibody against BKPyV. This partially randomized, single-blinded, and placebo-controlled trial enrolled 40 healthy participants randomized (3:1) to receive either single or multiple ascending doses (SAD/MAD) of potravitug or placebo intravenously. In the SAD phase, 16 participants were enrolled in 4 cohorts (<i>n</i> = 4 each) with escalating doses of 100, 500, 1000, and 2000 mg. In the MAD phase, 24 participants were enrolled in 3 consecutive cohorts (<i>n</i> = 8 each) with escalating doses of 500, 1000, and 2000 mg administered four times at four-week intervals. The primary outcome was incidence, frequency, and severity of treatment-emergent adverse events (TEAEs). Secondary outcomes included pharmacokinetic parameters and incidence of anti-drug antibodies. The ex vivo neutralization capacity was an exploratory pharmacodynamic outcome. In SAD cohorts, 17 TEAEs occurred in 7 (58.3%) active and 3 in 2 (50.0%) placebo recipients. In MAD cohorts, 49 TEAEs occurred in 13 (72.2%) active and 21 in 5 (83.3%) placebo recipients. No dose-limiting toxicities or anti-drug antibodies were detected, indicating a favorable safety profile. Dose-proportional increases in <i>C</i>_max and AUC, with a half-life characteristic of monoclonal antibodies, were observed. Based on pharmacokinetic-pharmacodynamic modeling, a 1000 mg intravenous dose administered four times at four-week intervals is expected to maintain sufficient drug concentrations and receptor occupancy of VP1 (BKPyV major capsid protein) in both the blood and kidney for at least 1 year.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70316","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144814538","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":"Insights From a User Experience-Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials","authors":"Yue Ma,&nbsp;Le Li,&nbsp;Gaili Gao,&nbsp;Huan Zhou,&nbsp;Jianmiao Yang,&nbsp;Jiao Zheng,&nbsp;Li Zheng,&nbsp;Lu Zhang,&nbsp;Min Jiang,&nbsp;Pu Li,&nbsp;Wenjing Zhou,&nbsp;Xia Chen,&nbsp;Ying Wang,&nbsp;Weiyi Zheng,&nbsp;Yan Zhang","doi":"10.1111/cts.70307","DOIUrl":"10.1111/cts.70307","url":null,"abstract":"<p>The decentralized clinical trial (DCT) approach may potentially improve patient accrual and diversity and reduce logistical burden; however, its implementation in China is still in its infancy due to limited practical experience and guidance. We utilized stakeholder engagement research to simulate DCT processes and investigate their feasibility and applicability in a local context. This study, conducted between October 2023 and June 2024, engaged stakeholders to simulate the roles of the investigator, study nurse/pharmacist, and patient in a DCT, and explored feasibility, challenges, and procedures locally. Using a mixed-method approach including focus group interviews, heuristic evaluation, usability testing, surveys, and one-on-one interviews, four DCT elements (eConsent, direct-from-patient sample collection, televisits, and direct-to-patient investigational medicine delivery) were simulated at 11 Chinese investigational sites with 36 researchers. Pain points, stakeholder requirements, and key challenges were identified; standardized procedures and a user journey map were developed to provide a visual representation of the DCT process, encouraging broader adoption. The researchers reported high satisfaction across all DCT elements. Key challenges included patients' DCT system process ease of use, lack of thoroughness or attention remotely, integrating online (system) and offline (hospital/home) visits, patient risk management, maintaining medication compliance remotely, and DCT system compatibility, among others. Standard procedures were developed for each DCT element, addressing issues like identity verification and data privacy based on user perspectives. This study provided insights on implementing DCTs in China, identifying areas that need optimization to meet local regulatory and stakeholders' requirements. The standardized framework may be referenced when adapting future DCT elements.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12334847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805227","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":"Sustained Community Involvement in Translational Research: Evaluating the Acceptability of a Multisession Community Engagement Studio Approach","authors":"Carmen R. Valdez,&nbsp;Grace Schrobilgen,&nbsp;Ricardo Garay,&nbsp;Monica Guzman,&nbsp;Carl Webb,&nbsp;Vidya Lakshminarayan,&nbsp;Eliel Oliveira,&nbsp;Anjum Khurshid","doi":"10.1111/cts.70312","DOIUrl":"10.1111/cts.70312","url":null,"abstract":"<p>This study expands the Community Engagement Studio (CE Studio) approach to cultivate deeper, more sustained community involvement in translational research. While traditional CE Studios typically convene a single community expert panel for research input, this study extended the approach to host multiple sessions with multiple diverse panels over a two-year period. The sessions were held virtually and were delivered by a Community Health Worker (CHW), who drew on deep community ties to also conduct strategic outreach, recruitment, and orientation of the panels to the CE Studio approach. The researchers seeking input from the CE Studio panels aimed to develop a health information platform accessible to underserved populations. Community experts participating in four CE Studio panels (African American, Asian American, and English and Spanish-speaking Latinx communities) met on five occasions for a total of 20 CE sessions and completed a postparticipation survey (<i>n</i> = 15) and focus group (<i>n</i> = 16). Participants reported stronger bonds with the research institution and increased appreciation for the value of translational research because of their prolonged participation. The presence of a CHW was viewed as essential to trust-building and sustained panel participation. The study highlights the role of diverse perspectives in shaping research design and technology development, emphasizing that investments in sustained community engagement can enhance the rigor of translational research. Attendance fluctuations and the pacing of sessions were challenges, especially during the pandemic. Nevertheless, the expanded CE Studio approach offers a promising framework for bridging gaps between academic institutions and historically marginalized communities.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 8","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12334358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805228","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}