Pub Date : 2025-10-30DOI: 10.1016/j.conctc.2025.101566
Manuel Hermosilla
Background
Gender disparities persist in clinical trial leadership, with women underrepresented as principal investigators (PIs). While previous studies have documented these disparities, they have largely relied on limited datasets focused on specific therapeutic areas. Previous studies have also neglected potential gender differences in trialist career trajectories. This study examines gender representation in clinical trial leadership using the most comprehensive dataset available, assessing trends over time and gender differences in trialist career trajectories.
Methods
I analyzed a large sample of clinical trials submitted to ClinicalTrials.gov from 2010 to 2023. PI gender was inferred using algorithmic classification based on first names. I estimated the probability of female PI leadership for each trial year using logistic regression, adjusting for trial characteristics. To assess career trajectories, I examined the number of trials led by male and female PIs within fixed time horizons and assessed gender differences and their evolution in time using Poisson regression models.
Results
Among nearly 160,000 trials analyzed, female representation increased from 32 % in 2010 to 41 % in 2023. Female PI leadership remained lowest in cardiovascular trials (20 %) and highest in behavioral intervention trials (50 %). Although male PIs lead more trials than female PIs over all horizons after entering the field, the gap has narrowed over time. In 2010, male PIs led 7 % more trials than female PIs within their first three years after entering the field; by 2020, this difference had declined to 1 % and become statistically insignificant.
Conclusions
Although female PIs remain underrepresented in clinical trial leadership, the gap is narrowing, particularly in terms of early-career progression. Future research should explore the underlying causes of these trends, including bias, career–family trade-offs, and the structural and behavioral mechanisms that shape sorting across medical specialties. Additionally, recent evidence suggests that female PIs may positively influence trial performance—particularly in patient recruitment diversity and safety outcomes, which highlights the broader significance of gender equity in clinical research.
{"title":"Representation and career trajectories of female principal investigators in clinical trials, 2010–2023","authors":"Manuel Hermosilla","doi":"10.1016/j.conctc.2025.101566","DOIUrl":"10.1016/j.conctc.2025.101566","url":null,"abstract":"<div><h3>Background</h3><div>Gender disparities persist in clinical trial leadership, with women underrepresented as principal investigators (PIs). While previous studies have documented these disparities, they have largely relied on limited datasets focused on specific therapeutic areas. Previous studies have also neglected potential gender differences in trialist career trajectories. This study examines gender representation in clinical trial leadership using the most comprehensive dataset available, assessing trends over time and gender differences in trialist career trajectories.</div></div><div><h3>Methods</h3><div>I analyzed a large sample of clinical trials submitted to <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> from 2010 to 2023. PI gender was inferred using algorithmic classification based on first names. I estimated the probability of female PI leadership for each trial year using logistic regression, adjusting for trial characteristics. To assess career trajectories, I examined the number of trials led by male and female PIs within fixed time horizons and assessed gender differences and their evolution in time using Poisson regression models.</div></div><div><h3>Results</h3><div>Among nearly 160,000 trials analyzed, female representation increased from 32 % in 2010 to 41 % in 2023. Female PI leadership remained lowest in cardiovascular trials (20 %) and highest in behavioral intervention trials (50 %). Although male PIs lead more trials than female PIs over all horizons after entering the field, the gap has narrowed over time. In 2010, male PIs led 7 % more trials than female PIs within their first three years after entering the field; by 2020, this difference had declined to 1 % and become statistically insignificant.</div></div><div><h3>Conclusions</h3><div>Although female PIs remain underrepresented in clinical trial leadership, the gap is narrowing, particularly in terms of early-career progression. Future research should explore the underlying causes of these trends, including bias, career–family trade-offs, and the structural and behavioral mechanisms that shape sorting across medical specialties. Additionally, recent evidence suggests that female PIs may positively influence trial performance—particularly in patient recruitment diversity and safety outcomes, which highlights the broader significance of gender equity in clinical research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101566"},"PeriodicalIF":1.4,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145473718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-28DOI: 10.1016/j.conctc.2025.101565
Zhao Wenwen , Wang Jiaqi , Sun Jing , Tim R.E. Harris , Li Haixia , Zhao Xiaoqian , Liu Rui , Gu Xinyu , Ma Shumin , Lou Zhifei , Liu Lifei
Purpose
To evaluate traditional Chinese medicine (TCM) and acupuncture in addition to estrogen/progesterone therapy in the post-operative management of intrauterine adhesions.
Patients and methods
A single center, randomized, non-blinded, controlled trial in which participants received either estrogen/progesterone (group 1), or estrogen/progesterone combined with TCM (group 2), or estrogen/progesterone combined with TCM and navel acupuncture (group 3) for 3 months following transcervical resection of adhesions. The primary outcome was the difference in the uterine adhesion (American Fertility Society, AFS) score at 3 months post hysteroscopy assessed on days 3–7 post menses. The secondary outcomes included endometrial thickness and traditional Chinese medicine score at 3 months, and pregnancy rate at 6 months after hysteroscopy.
Results
120 participants were recruited. There were no differences in AFS at baseline but at 3 months AFS scores were [(4.53 (95 % CI 3.85–5.20) vs. 3.58 (95 % CI 2.94–4.21) vs. 2.70 (95 % CI 2.14–3.26), p < 0.001, pairwise comparison p < 0.05)]. Endometrial thickness increased in all groups [6.20 (95 % CI 5.67–6.72) vs. 6.88 (95 % CI 6.38–7.38) vs. 7.82 (95 % CI 7.26–8.38), pairwise comparison p < 0.05)]. There was a statistically significant difference in pregnancy rates between groups 3 and 1 [42.5 % vs. 10.0 %, p < 0.05)], and group 3 and 2 [ 42.5 % vs. 20.0 %, p < 0.05)], but not between group 1 and group 2 (p > 0.05).
Conclusion
This pilot randomized controlled trial provides provisional data that the addition of TCM and acupuncture to estrogen therapy following the surgical treatment of intrauterine adhesions may improve outcomes.
Trial registration
International Traditional Medicine Clinical Trial Registry (ITMCTR2024000258) (http://itmctr.ccebtcm.org.cn/en-US), a member of the WHO Primary Network of ICTRP.
目的探讨中药与针刺联合雌激素/孕酮治疗术后宫腔粘连的疗效。患者和方法单中心、随机、非盲、对照试验，受试者在经宫颈粘连切除术后接受雌激素/黄体酮（1组）、雌激素/黄体酮联合中药（2组）、雌激素/黄体酮联合中药和脐针（3组）治疗3个月。主要观察指标是宫腔镜检查后3个月子宫粘连（美国生育学会，AFS）评分的差异，评估时间为月经后3 - 7天。次要观察指标为宫腔镜术后3个月子宫内膜厚度、中医评分、6个月妊娠率。结果共招募120名受试者。基线时AFS无差异，但3个月时AFS评分为(4.53 (95% CI 3.85-5.20) vs. 3.58 （95% CI 2.94-4.21) vs. 2.70 (95% CI 2.14-3.26), p < 0.001，两两比较p <； 0.05）。各组子宫内膜厚度均增加[6.20 (95% CI 5.67 ~ 6.72) vs. 6.88 (95% CI 6.38 ~ 7.38) vs. 7.82 (95% CI 7.26 ~ 8.38)，两两比较p <； 0.05)]。3组与1组妊娠率差异有统计学意义[42.5%比10.0%,p < 0.05)]， 3组与2组妊娠率差异有统计学意义[42.5%比20.0%,p < 0.05)]， 1组与2组妊娠率差异无统计学意义（p < 0.05）。结论本随机对照试验提供了初步数据，表明在宫腔粘连手术治疗后，中药和针刺联合雌激素治疗可改善预后。试验注册国际传统医学临床试验注册中心（ITMCTR2024000258） （http://itmctr.ccebtcm.org.cn/en-US）， ICTRP的WHO初级网络成员。
{"title":"A randomized clinical trial of surgical intervention with or without acupuncture combined with traditional Chinese medicine to treat intrauterine adhesions","authors":"Zhao Wenwen , Wang Jiaqi , Sun Jing , Tim R.E. Harris , Li Haixia , Zhao Xiaoqian , Liu Rui , Gu Xinyu , Ma Shumin , Lou Zhifei , Liu Lifei","doi":"10.1016/j.conctc.2025.101565","DOIUrl":"10.1016/j.conctc.2025.101565","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate traditional Chinese medicine (TCM) and acupuncture in addition to estrogen/progesterone therapy in the post-operative management of intrauterine adhesions.</div></div><div><h3>Patients and methods</h3><div>A single center, randomized, non-blinded, controlled trial in which participants received either estrogen/progesterone (group 1), or estrogen/progesterone combined with TCM (group 2), or estrogen/progesterone combined with TCM and navel acupuncture (group 3) for 3 months following transcervical resection of adhesions. The primary outcome was the difference in the uterine adhesion (American Fertility Society, AFS) score at 3 months post hysteroscopy assessed on days 3–7 post menses. The secondary outcomes included endometrial thickness and traditional Chinese medicine score at 3 months, and pregnancy rate at 6 months after hysteroscopy.</div></div><div><h3>Results</h3><div>120 participants were recruited. There were no differences in AFS at baseline but at 3 months AFS scores were [(4.53 (95 % CI 3.85–5.20) vs. 3.58 (95 % CI 2.94–4.21) vs. 2.70 (95 % CI 2.14–3.26), <em>p</em> < 0.001, pairwise comparison <em>p</em> < 0.05)]. Endometrial thickness increased in all groups [6.20 (95 % CI 5.67–6.72) vs. 6.88 (95 % CI 6.38–7.38) vs. 7.82 (95 % CI 7.26–8.38), pairwise comparison <em>p</em> < 0.05)]. There was a statistically significant difference in pregnancy rates between groups 3 and 1 [42.5 % vs. 10.0 %, <em>p</em> < 0.05)], and group 3 and 2 [ 42.5 % vs. 20.0 %, <em>p</em> < 0.05)], but not between group 1 and group 2 (<em>p</em> > 0.05).</div></div><div><h3>Conclusion</h3><div>This pilot randomized controlled trial provides provisional data that the addition of TCM and acupuncture to estrogen therapy following the surgical treatment of intrauterine adhesions may improve outcomes.</div></div><div><h3>Trial registration</h3><div>International Traditional Medicine Clinical Trial Registry (ITMCTR2024000258) (<span><span>http://itmctr.ccebtcm.org.cn/en-US</span><svg><path></path></svg></span>), a member of the WHO Primary Network of ICTRP.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101565"},"PeriodicalIF":1.4,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145473716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-26DOI: 10.1016/j.conctc.2025.101564
Susan B. Racette , Jordan A. Gunning , Danielle E. Eagan , Isabella Zaniletti , Tracy L. Smith , Candice J. DeCuna , Yehansa S. Hettiwatte , Migbare T. Demeke , Nevine A. Khan , Emily L. Aliskevich , Janina Krell-Roesch , Yonas E. Geda
Background and objective
Time-restricted eating (TRE) may slow neurodegeneration and cognitive decline by stimulating metabolic processes that are neuroprotective. The primary aim of the TRE in Alzheimer's Disease (TREAD) pilot trial is to evaluate the feasibility of implementing a TRE intervention among individuals with mild cognitive impairment (MCI) and to obtain preliminary data on cognitive domains and blood biomarkers that are responsive to TRE.
Methods
TREAD is an intervention trial for 30 adults aged 55–89 years with MCI. A pre/post design is used, with neuropsychological assessments, surveys, and blood biomarkers of cardiometabolic health and AD obtained before and after the intervention. The TRE intervention involves 16 h of continuous fasting and an 8 h eating window on 5 or more days per week for 12 weeks. Feasibility measures include participant enrollment, retention, adherence, acceptability of the intervention, and safety. Cognitive measures include executive function, working memory, processing speed, auditory attention, auditory verbal learning, visuospatial memory, category fluency, and phonemic fluency.
Summary
TREAD is exploring an innovative approach to address cognitive decline and will provide critical preliminary data to inform and power a larger, longer-term, randomized controlled trial of TRE on cognitive trajectory among adults with cognitive impairment.
{"title":"Time-restricted eating in Alzheimer's disease: TREAD pilot trial design","authors":"Susan B. Racette , Jordan A. Gunning , Danielle E. Eagan , Isabella Zaniletti , Tracy L. Smith , Candice J. DeCuna , Yehansa S. Hettiwatte , Migbare T. Demeke , Nevine A. Khan , Emily L. Aliskevich , Janina Krell-Roesch , Yonas E. Geda","doi":"10.1016/j.conctc.2025.101564","DOIUrl":"10.1016/j.conctc.2025.101564","url":null,"abstract":"<div><h3>Background and objective</h3><div>Time-restricted eating (TRE) may slow neurodegeneration and cognitive decline by stimulating metabolic processes that are neuroprotective. The primary aim of the TRE in Alzheimer's Disease (TREAD) pilot trial is to evaluate the feasibility of implementing a TRE intervention among individuals with mild cognitive impairment (MCI) and to obtain preliminary data on cognitive domains and blood biomarkers that are responsive to TRE.</div></div><div><h3>Methods</h3><div>TREAD is an intervention trial for 30 adults aged 55–89 years with MCI. A pre/post design is used, with neuropsychological assessments, surveys, and blood biomarkers of cardiometabolic health and AD obtained before and after the intervention. The TRE intervention involves 16 h of continuous fasting and an 8 h eating window on 5 or more days per week for 12 weeks. Feasibility measures include participant enrollment, retention, adherence, acceptability of the intervention, and safety. Cognitive measures include executive function, working memory, processing speed, auditory attention, auditory verbal learning, visuospatial memory, category fluency, and phonemic fluency.</div></div><div><h3>Summary</h3><div>TREAD is exploring an innovative approach to address cognitive decline and will provide critical preliminary data to inform and power a larger, longer-term, randomized controlled trial of TRE on cognitive trajectory among adults with cognitive impairment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101564"},"PeriodicalIF":1.4,"publicationDate":"2025-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-23DOI: 10.1016/j.conctc.2025.101562
Isuru Ratnayake , Anh-Tuan Do , Daniel Gajewski , Sam Pepper , Oluwatobiloba Ige , Natalie Streeter , Tara L. Lin , Matthew McGuirk , Byron Gajewski , Dinesh Pal Mudaranthakam
Background
Drug development in cancer medicine relies on high-quality clinical trials, and the success of these trials depends on the design, optimization, and execution. Delays often arise from the study startup process, which can take 6 months or more. Complex challenges, including regulatory hurdles, contract negotiations, and inefficiencies in site activation, contribute to these delays. Streamlining these processes is critical to accelerating patients' access to potentially life-saving therapies.
Method
Data from the University of Kansas Cancer Center (KUCC) were used to analyze studies initiated between 2018 and 2022. The accrual percentage was computed based on the number of enrolled participants and the desired accrual goal. Accrual success was determined by comparing the enrollment rate to predefined threshold values (50 %, 70 %, or 90 %).
Results
Studies that achieve or surpass the 70 % accrual threshold typically exhibit a median activation time of 140.5 days. In contrast, studies that fall short of the accrual goal tend to have a median activation time of 187 days, indicating shorter median activation times are associated with successful studies. The Wilcoxon rank-sum test (W = 13,607, p = 0.001) indicated that early-phase studies had significantly longer activation times than late-phase studies. We also conducted the study with 50 % and 90 % accrual thresholds; our findings remained consistent.
Conclusions
Longer activation times are associated with lower project success, and early-phase studies tend to be more successful than late-phase studies. Therefore, by reducing impediments to the approval process, we can facilitate quicker approvals, increasing the success of studies regardless of phase.
癌症药物的开发依赖于高质量的临床试验，而这些试验的成功取决于设计、优化和执行。延迟通常出现在研究启动过程中，这可能需要6个月或更长时间。复杂的挑战，包括监管障碍、合同谈判和现场激活效率低下，都是造成这些延误的原因。简化这些过程对于加快患者获得可能挽救生命的疗法至关重要。方法使用堪萨斯大学癌症中心（KUCC）的数据分析2018年至2022年开展的研究。应计百分比是根据报名参加人数和期望的应计目标计算的。通过将入学率与预定义的阈值（50%、70%或90%）进行比较来确定累计成功率。结果达到或超过70%累积阈值的研究通常显示中位激活时间为140.5天。相比之下，未达到应计目标的研究往往有187天的中位激活时间，这表明更短的中位激活时间与成功的研究有关。Wilcoxon秩和检验（W = 13,607, p = 0.001）表明，早期研究的激活时间明显长于后期研究。我们还以50%和90%的应计阈值进行了研究；我们的发现是一致的。较长的激活时间与较低的项目成功率相关，并且早期研究往往比后期研究更成功。因此，通过减少审批过程中的障碍，我们可以促进更快的审批，增加研究的成功率，无论阶段如何。
{"title":"Evaluating the impact of delayed study startup on accrual in cancer studies","authors":"Isuru Ratnayake , Anh-Tuan Do , Daniel Gajewski , Sam Pepper , Oluwatobiloba Ige , Natalie Streeter , Tara L. Lin , Matthew McGuirk , Byron Gajewski , Dinesh Pal Mudaranthakam","doi":"10.1016/j.conctc.2025.101562","DOIUrl":"10.1016/j.conctc.2025.101562","url":null,"abstract":"<div><h3>Background</h3><div>Drug development in cancer medicine relies on high-quality clinical trials, and the success of these trials depends on the design, optimization, and execution. Delays often arise from the study startup process, which can take 6 months or more. Complex challenges, including regulatory hurdles, contract negotiations, and inefficiencies in site activation, contribute to these delays. Streamlining these processes is critical to accelerating patients' access to potentially life-saving therapies.</div></div><div><h3>Method</h3><div>Data from the University of Kansas Cancer Center (KUCC) were used to analyze studies initiated between 2018 and 2022. The accrual percentage was computed based on the number of enrolled participants and the desired accrual goal. Accrual success was determined by comparing the enrollment rate to predefined threshold values (50 %, 70 %, or 90 %).</div></div><div><h3>Results</h3><div>Studies that achieve or surpass the 70 % accrual threshold typically exhibit a median activation time of 140.5 days. In contrast, studies that fall short of the accrual goal tend to have a median activation time of 187 days, indicating shorter median activation times are associated with successful studies. The Wilcoxon rank-sum test (W = 13,607, p = 0.001) indicated that early-phase studies had significantly longer activation times than late-phase studies. We also conducted the study with 50 % and 90 % accrual thresholds; our findings remained consistent.</div></div><div><h3>Conclusions</h3><div>Longer activation times are associated with lower project success, and early-phase studies tend to be more successful than late-phase studies. Therefore, by reducing impediments to the approval process, we can facilitate quicker approvals, increasing the success of studies regardless of phase.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101562"},"PeriodicalIF":1.4,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145363629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Presbyopia is an age-related eye condition observed in older people (who are above 40 years), whereby there is a gradual loss of the ability to focus on near items. Some common symptoms include seeing near as blurred, eye strain, and a headache, which may impair the quality of life. The general solution to presbyopia using corrective lenses or surgery interventions has been available. But the emergent philosophy focuses on non-pharmacological methods, such as yogic eye practice and Trataka Kriya. This technique involves steady gazing designed to enhance the function of ocular muscles and improve near vision. This current study outlines a single-blind randomized controlled trial to evaluate Trataka Kriya's effectiveness in managing presbyopia. A total of 286 participants will be recruited, all above 35 years of age with a confirmed diagnosis of presbyopia. The participants will be randomly allocated into two groups, where one will receive standard medical care and the other will receive the practice of Trataka Kriya in addition to standard medical care. The intervention plan will be 12 weeks, where visual acuity, eye strain, and other eye-related characteristics will be assessed at the beginning and end of the intervention. The primary outcomes will be near visual acuity and eye strain, with secondary outcomes including other eye-related characteristics. The protocol outlines key criteria to evaluate whether the addition of Trataka Kriya to standard care is effective in improving near vision and reducing eye strain symptoms in individuals with presbyopia.
Trial registration
Clinical Trials Registry - India (CTRI); Registration number: CTRI/2023/09/057523; Registration Date: September 12, 2023.
{"title":"A protocol for management of presbyopia through ancient yogic eye purificatory method: A randomized controlled trial","authors":"Lavya Shetty , Yogish Subraya Kamath , Annapoorna K , Gitika Bhasin , Akhilesh Kumar Pandey","doi":"10.1016/j.conctc.2025.101563","DOIUrl":"10.1016/j.conctc.2025.101563","url":null,"abstract":"<div><div>Presbyopia is an age-related eye condition observed in older people (who are above 40 years), whereby there is a gradual loss of the ability to focus on near items. Some common symptoms include seeing near as blurred, eye strain, and a headache, which may impair the quality of life. The general solution to presbyopia using corrective lenses or surgery interventions has been available. But the emergent philosophy focuses on non-pharmacological methods, such as yogic eye practice and Trataka Kriya. This technique involves steady gazing designed to enhance the function of ocular muscles and improve near vision. This current study outlines a single-blind randomized controlled trial to evaluate Trataka Kriya's effectiveness in managing presbyopia. A total of 286 participants will be recruited, all above 35 years of age with a confirmed diagnosis of presbyopia. The participants will be randomly allocated into two groups, where one will receive standard medical care and the other will receive the practice of Trataka Kriya in addition to standard medical care. The intervention plan will be 12 weeks, where visual acuity, eye strain, and other eye-related characteristics will be assessed at the beginning and end of the intervention. The primary outcomes will be near visual acuity and eye strain, with secondary outcomes including other eye-related characteristics. The protocol outlines key criteria to evaluate whether the addition of Trataka Kriya to standard care is effective in improving near vision and reducing eye strain symptoms in individuals with presbyopia.</div></div><div><h3>Trial registration</h3><div>Clinical Trials Registry - India (CTRI); Registration number: CTRI/2023/09/057523; Registration Date: September 12, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101563"},"PeriodicalIF":1.4,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145363630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-15DOI: 10.1016/j.conctc.2025.101560
Ivana Bardino Novosel , Jan Christensen , Mikkel Damgaard Justiniano , Astrid Siemens Lorenzen , Jakob Lorentzen
{"title":"The THRIVE-CP trial - Targeted home-based training with real-time feedback to improve versatile movement behaviors and enhance outcomes in adolescents and young adults with Cerebral Palsy: Protocol for a randomized controlled trial","authors":"Ivana Bardino Novosel , Jan Christensen , Mikkel Damgaard Justiniano , Astrid Siemens Lorenzen , Jakob Lorentzen","doi":"10.1016/j.conctc.2025.101560","DOIUrl":"10.1016/j.conctc.2025.101560","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101560"},"PeriodicalIF":1.4,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-12DOI: 10.1016/j.conctc.2025.101561
John J. Sramek, Modesto S. Carrillo, Neal R. Cutler
Establishing a private clinical trial site is an increasingly appealing but complex opportunity for physicians interested in becoming Principal Investigators (PIs) in FDA-regulated research. This article provides a comprehensive overview for aspiring PIs, detailing the critical requirements and best practices for launching and operating a successful site.
The topics covered include regulatory responsibilities, financial considerations, infrastructure needs, staffing roles, investigational product handling, standard operating procedures, IRB oversight, informed consent, and patient recruitment and retention strategies. Special emphasis is placed on compliance with FDA regulations and Good Clinical Practice (GCP) standards, ensuring data integrity and the protection of study participants.
The paper highlights the importance of robust infrastructure—from calibrated laboratory equipment and secure drug storage to electronic data capture systems—and the need for well-trained support staff, including clinical research coordinators and sub-investigators. The recruitment and retention of diverse participants is explored through ethical, patient-centered engagement strategies. Additionally, guidance is provided on navigating site feasibility assessments, sponsor negotiations, and the startup study process.
Drawing from the authors’ experience establishing clinical trial sites and contract research organizations, this guide offers strategic insights on building sponsor relationships, evaluating protocol feasibility, and enhancing site performance metrics. The evolving clinical trial landscape—driven by new therapeutic developments and digital technologies—demands that PIs not only meet regulatory standards but also demonstrate leadership, operational excellence, and a commitment to scientific integrity.
{"title":"Establishing a clinical trial site: A primer for aspiring principal investigators","authors":"John J. Sramek, Modesto S. Carrillo, Neal R. Cutler","doi":"10.1016/j.conctc.2025.101561","DOIUrl":"10.1016/j.conctc.2025.101561","url":null,"abstract":"<div><div>Establishing a private clinical trial site is an increasingly appealing but complex opportunity for physicians interested in becoming Principal Investigators (PIs) in FDA-regulated research. This article provides a comprehensive overview for aspiring PIs, detailing the critical requirements and best practices for launching and operating a successful site.</div><div>The topics covered include regulatory responsibilities, financial considerations, infrastructure needs, staffing roles, investigational product handling, standard operating procedures, IRB oversight, informed consent, and patient recruitment and retention strategies. Special emphasis is placed on compliance with FDA regulations and Good Clinical Practice (GCP) standards, ensuring data integrity and the protection of study participants.</div><div>The paper highlights the importance of robust infrastructure—from calibrated laboratory equipment and secure drug storage to electronic data capture systems—and the need for well-trained support staff, including clinical research coordinators and sub-investigators. The recruitment and retention of diverse participants is explored through ethical, patient-centered engagement strategies. Additionally, guidance is provided on navigating site feasibility assessments, sponsor negotiations, and the startup study process.</div><div>Drawing from the authors’ experience establishing clinical trial sites and contract research organizations, this guide offers strategic insights on building sponsor relationships, evaluating protocol feasibility, and enhancing site performance metrics. The evolving clinical trial landscape—driven by new therapeutic developments and digital technologies—demands that PIs not only meet regulatory standards but also demonstrate leadership, operational excellence, and a commitment to scientific integrity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101561"},"PeriodicalIF":1.4,"publicationDate":"2025-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-11DOI: 10.1016/j.conctc.2025.101559
Alexandra R. Brown , Edward F. Ellerbeck , Debra K. Sullivan , Eve-Lynn Nelson , Jennifer R. Klemp , Byron J. Gajewski , Jarron Michael Saint Onge , Christie A. Befort
Rural communities experience disproportionately high rates of obesity and related chronic diseases. Rural residents report a lack of weight control programs within their communities, leaving primary care physicians (PCPs)at the center of obesity treatment. PCP involvement significantly enhances uptake and maintenance of weight loss behaviors, but PCPs face significant challenges in delivering consistent, high quality obesity treatment. Capitalizing on the rapid expansion of telehealth, this cluster-randomized trial will evaluate the effectiveness of a novel team-based treatment approach in reducing weight compared to standard quarterly PCP visits. Team Care is a telemedicine approach that pairs intensive telemedicine group visits with quarterly individual team-based clinic visits that simultaneously engage the participant, the local PCP, and a lifestyle coach. This combines the benefits of group-based treatment with home-based telemedicine delivery, and critically, integrates team-based care in local rural clinics. We hypothesize that the team-based approach will be more effective in achieving weight loss at 18 months. Sixteen practices from rural Kansas will be randomized to deliver the team-based approach or standard of care to 35 participants per practice (n = 560) age 20 to 75 with a BMI at least 30 kg/m2. Secondary endpoints include clinical cut points for weight loss, quality of life indicators, and implementation process measures. This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the current standard of care. The results may warrant a new standard of care for obesity treatment in rural primary care practices.
{"title":"Protocol for the rural engagement in TelemedTeam for options in obesity treatment solutions (RE-TOOL): Cluster randomized trial investigating team-based telemedicine in rural primary care","authors":"Alexandra R. Brown , Edward F. Ellerbeck , Debra K. Sullivan , Eve-Lynn Nelson , Jennifer R. Klemp , Byron J. Gajewski , Jarron Michael Saint Onge , Christie A. Befort","doi":"10.1016/j.conctc.2025.101559","DOIUrl":"10.1016/j.conctc.2025.101559","url":null,"abstract":"<div><div>Rural communities experience disproportionately high rates of obesity and related chronic diseases. Rural residents report a lack of weight control programs within their communities, leaving primary care physicians (PCPs)at the center of obesity treatment. PCP involvement significantly enhances uptake and maintenance of weight loss behaviors, but PCPs face significant challenges in delivering consistent, high quality obesity treatment. Capitalizing on the rapid expansion of telehealth, this cluster-randomized trial will evaluate the effectiveness of a novel team-based treatment approach in reducing weight compared to standard quarterly PCP visits. Team Care is a telemedicine approach that pairs intensive telemedicine group visits with quarterly individual team-based clinic visits that simultaneously engage the participant, the local PCP, and a lifestyle coach. This combines the benefits of group-based treatment with home-based telemedicine delivery, and critically, integrates team-based care in local rural clinics. We hypothesize that the team-based approach will be more effective in achieving weight loss at 18 months. Sixteen practices from rural Kansas will be randomized to deliver the team-based approach or standard of care to 35 participants per practice (n = 560) age 20 to 75 with a BMI at least 30 kg/m2. Secondary endpoints include clinical cut points for weight loss, quality of life indicators, and implementation process measures. This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the current standard of care. The results may warrant a new standard of care for obesity treatment in rural primary care practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101559"},"PeriodicalIF":1.4,"publicationDate":"2025-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-09DOI: 10.1016/j.conctc.2025.101557
Rui Fang , Wanyao Yang , Yue Zhou , Lei Zhao , Le Xie , Jiaxuan Tian , Danhong Liu , Shasha Zhou , Qing Chen , Yanmei Peng , Yunhua Luo , Dahua Wu , Jinwen Ge
<div><h3>Background</h3><div>Convalescent coronavirus disease 2019 (COVID-19) refers to a series of clinical syndromes in patients with COVID-19 infection that follow the relevant discharge indications but do not fulfill the criteria for a clinical cure, and these patients are discharged from the hospital with residual multifunctional deficits, including coughing, fatigue, and insomnia. Due to the prolonged convalescent COVID-19 infection, patients continue to experience symptoms or develop new symptoms after three months of infection, and some symptoms persist for over two months without any apparent triggers, which has a significant impact on the health status and quality of life of the population. Patients with convalescent COVID-19 lack a definitive pharmacological treatment. Traditional Chinese medicine (TCM) exhibits a distinct, synergistic effect on the treatment of convalescent COVID-19. However, there exists a limited number of clinical trials on TCM with lower evidence levels in convalescent COVID-19. Therefore, randomized trials are urgently required.</div></div><div><h3>Methods</h3><div>A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial was performed to evaluate the efficacy and safety of Shenlingkangfu (SLKF) granules in treating patients with convalescent COVID-19 and lung-spleen qi deficiency syndrome. Eligible participants were aged 18–75 years, had a confirmed severe acute respiratory syndrome coronavirus 2 infection following a positive result for COVID-19 via polymerase chain reaction (PCR) or rapid antigen test at least six months prior, and satisfied clinical criteria. Individuals with a history of severe pulmonary dysfunction or major liver and kidney illness or those on medications were excluded. Multicenter subjects satisfying all criteria were assigned (1:1) randomly into an intervention group and a control group. After a 2-day adjustment period, a total of 154 participants were randomly divided into an intervention group and a control group. The intervention group was given the SLKF granules orally once a bag, 16.9 g, twice daily, whereas the control group received the SLKF granule simulation at the same dosage. The trial was conducted over 1 month, with assessments performed at baseline and 3 months.</div></div><div><h3>Results</h3><div>The primary outcomes were the therapeutic efficacy rate and total clinical symptom score. The secondary outcomes included the fatigue self-assessment scale, pain visual analog scale, Pittsburgh sleep quality index, mini-mental state examination, hospital anxiety and depression scale, TCM syndrome score, C-reactive protein, erythrocyte sedimentation rate, and interleukin-6. Three routine examinations, liver and kidney function tests, and electrocardiography were used as safety indicators.</div></div><div><h3>Conclusions</h3><div>This study aimed to verify whether SLKF granules can significantly improve clinical symptoms, including fatigue, loss of appetit
{"title":"Efficacy and safety of Chinese medicine compound for the convalescent COVID-19 patients: Protocol of a multi-centered, randomized, double-blinded, placebo-controlled clinical trial","authors":"Rui Fang , Wanyao Yang , Yue Zhou , Lei Zhao , Le Xie , Jiaxuan Tian , Danhong Liu , Shasha Zhou , Qing Chen , Yanmei Peng , Yunhua Luo , Dahua Wu , Jinwen Ge","doi":"10.1016/j.conctc.2025.101557","DOIUrl":"10.1016/j.conctc.2025.101557","url":null,"abstract":"<div><h3>Background</h3><div>Convalescent coronavirus disease 2019 (COVID-19) refers to a series of clinical syndromes in patients with COVID-19 infection that follow the relevant discharge indications but do not fulfill the criteria for a clinical cure, and these patients are discharged from the hospital with residual multifunctional deficits, including coughing, fatigue, and insomnia. Due to the prolonged convalescent COVID-19 infection, patients continue to experience symptoms or develop new symptoms after three months of infection, and some symptoms persist for over two months without any apparent triggers, which has a significant impact on the health status and quality of life of the population. Patients with convalescent COVID-19 lack a definitive pharmacological treatment. Traditional Chinese medicine (TCM) exhibits a distinct, synergistic effect on the treatment of convalescent COVID-19. However, there exists a limited number of clinical trials on TCM with lower evidence levels in convalescent COVID-19. Therefore, randomized trials are urgently required.</div></div><div><h3>Methods</h3><div>A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial was performed to evaluate the efficacy and safety of Shenlingkangfu (SLKF) granules in treating patients with convalescent COVID-19 and lung-spleen qi deficiency syndrome. Eligible participants were aged 18–75 years, had a confirmed severe acute respiratory syndrome coronavirus 2 infection following a positive result for COVID-19 via polymerase chain reaction (PCR) or rapid antigen test at least six months prior, and satisfied clinical criteria. Individuals with a history of severe pulmonary dysfunction or major liver and kidney illness or those on medications were excluded. Multicenter subjects satisfying all criteria were assigned (1:1) randomly into an intervention group and a control group. After a 2-day adjustment period, a total of 154 participants were randomly divided into an intervention group and a control group. The intervention group was given the SLKF granules orally once a bag, 16.9 g, twice daily, whereas the control group received the SLKF granule simulation at the same dosage. The trial was conducted over 1 month, with assessments performed at baseline and 3 months.</div></div><div><h3>Results</h3><div>The primary outcomes were the therapeutic efficacy rate and total clinical symptom score. The secondary outcomes included the fatigue self-assessment scale, pain visual analog scale, Pittsburgh sleep quality index, mini-mental state examination, hospital anxiety and depression scale, TCM syndrome score, C-reactive protein, erythrocyte sedimentation rate, and interleukin-6. Three routine examinations, liver and kidney function tests, and electrocardiography were used as safety indicators.</div></div><div><h3>Conclusions</h3><div>This study aimed to verify whether SLKF granules can significantly improve clinical symptoms, including fatigue, loss of appetit","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101557"},"PeriodicalIF":1.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-08DOI: 10.1016/j.conctc.2025.101558
Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise
Background
Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).
Objective
This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.
Study design
This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.
Main outcome measures
Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.1,2
Conclusion
We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.
{"title":"RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial","authors":"Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise","doi":"10.1016/j.conctc.2025.101558","DOIUrl":"10.1016/j.conctc.2025.101558","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).</div></div><div><h3>Objective</h3><div>This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.</div></div><div><h3>Study design</h3><div>This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.</div></div><div><h3>Main outcome measures</h3><div>Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.<sup>1,2</sup></div></div><div><h3>Conclusion</h3><div>We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.</div></div><div><h3>Trial Registration Number</h3><div>NCT06768099 (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101558"},"PeriodicalIF":1.4,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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