Reviews on recent clinical trials最新文献

{"title":"Immunoinformatics Approach for Optimization of Targeted Vaccine Design: New Paradigm in Clinical Trials and Healthcare Management.","authors":"Virendra S Gomase, Rupali Sharma, Suchita P Dhamane","doi":"10.2174/0115748871374235250702065617","DOIUrl":"https://doi.org/10.2174/0115748871374235250702065617","url":null,"abstract":"<p><strong>Background: </strong>The immunoinformatics approach combines bioinformatics and computational tools, offering a revolutionary method for improving vaccine development by analyzing immune responses at the molecular level. Immunoinformatics enables the creation of customized vaccines designed for specific infections or cancer cells.</p><p><strong>Objective: </strong>The primary objective of immunoinformatics is to enhance the vaccine development process by predicting and boosting the body's immune response. It aims to identify potential immunogenic epitopes and biomarkers that are important for creating vaccines with greater specificity and efficacy, especially when dealing with large-scale data.</p><p><strong>Methods: </strong>Immunoinformatics utilizes a combination of proteomic, genomic, and epigenomic data, as well as machine learning algorithms and artificial intelligence techniques. These tools predict how various immunological components, e.g., T-cell and B-cell epitopes, interact with the immune system. This approach allows researchers to avoid traditional trial-and-error methods, enabling the efficient identification of potential vaccine candidates. Additionally, personalized vaccines can be developed by considering individual genetic and immunological characteristics.</p><p><strong>Results: </strong>The use of immunoinformatics techniques accelerates the screening of vaccine candidates, enhances patient stratification, and optimizes formulations for clinical trials. This approach has been shown to improve vaccine safety, efficacy, and development speed. It also holds promise for managing healthcare on a large scale by producing vaccines tailored to specific populations, thereby improving the overall effectiveness of vaccination programs.</p><p><strong>Conclusion: </strong>Immunoinformatics represents a transformative approach to vaccine research, improving clinical trial efficiency and enabling the development of more reliable, flexible, and personalized vaccines. This approach has the potential to significantly enhance global healthcare outcomes by accelerating the vaccine development process and optimizing vaccination strategies.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144660068","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}

{"title":"The Role of Animal Models in Huntington's Disease Clinical Trials: Decoding Genetic, Non-Genetic, and Molecular Pathways.","authors":"Aarti A Bhimanwar, Aditi S Kulkarni, Virendra S Gomase","doi":"10.2174/0115748871372165250625212002","DOIUrl":"https://doi.org/10.2174/0115748871372165250625212002","url":null,"abstract":"<p><strong>Background: </strong>Huntington's disease (HD) is a neurodegenerative disorder due to a CAG trinucleotide repeat expansion in the HD gene. Animal models have been instrumental in revealing the genetic and molecular bases of HD. While animal models cannot exactly model the human disease because of anatomical and lifespan differences, they are essential in revealing HD pathology and possible treatments.</p><p><strong>Objective: </strong>This review aimed to highlight the significance of animal models, particularly rodents, in deepening our knowledge of Huntington's disease. It underlines how non-genetic and genetic models have aided research and therapy innovation as well as their limitations.</p><p><strong>Methods: </strong>This review addresses the use of different models of animals, including genetic models, such as transgenic mice and non-genetic models, for example, invertebrates and non-human primates. It addresses the creation of these models through methods, such as gene transfer techniques and transgenic manipulation, to simulate the genetic defects that occur in humans. The applicability of model choice based on validity criteria, including symptom manifestation and treatment effectiveness, is also discussed.</p><p><strong>Results: </strong>This study underscores the effectiveness of the R6/2 mouse model, characterized by accelerated symptom onset and HD pathology. Progress in genetic engineering has also boosted the construction of murine and rat models that reproduce the hereditary aspects of HD, providing significant platforms for experimental investigation.</p><p><strong>Conclusion: </strong>Even with their limitations, animal models, especially rodents, continue to play a vital role in the study of HD pathogenesis and therapeutic intervention. These models still shed light on the disease and direct towards the identification of effective treatments.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144584707","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}

{"title":"Topical Application of Olive Oil in Preventing Pressure Injuries Among Hospitalized Patients with Mobility Limitations: A Cluster Randomized Trial in the United Arab Emirates.","authors":"Maraim Mohammed Saeed Almesmari, Rose Ekama Ilesanmi, Mona Gamal Mohamed","doi":"10.2174/0115748871363994250624201929","DOIUrl":"https://doi.org/10.2174/0115748871363994250624201929","url":null,"abstract":"<p><strong>Introduction: </strong>Pressure injuries (PIs) pose a significant threat to the safety of hospitalized, mobility-compromised patients globally. Olive oil has shown promising results in preventing PIs due to its high concentrations of monounsaturated fatty acids and phenol antioxidants, known for their anti-inflammatory and cell-protective properties. This study aimed to evaluate the effectiveness of topical olive oil combined with routine preventive interventions in reducing PI incidence.</p><p><strong>Methods: </strong>A single-blinded, cluster-randomized study was conducted among 80 hospitalized patients at risk of developing PIs. Participants were randomized into two clusters: the intervention group (IVG, n=40) received standard PI preventive care (skin assessment, repositioning, support surfaces) plus topical olive oil application for 7 consecutive days; the control group (CG, n=40) received only standard care. PI prevalence and Braden Scale scores were assessed at baseline and post-intervention (days 3-8). Data were analyzed using descriptive statistics and paired sample ttests.</p><p><strong>Results: </strong>At baseline, both groups had a PI prevalence of 52.5% (n=21). After the intervention, prevalence reduced to 5% (n=2) in IVG and 22.5% (n=9) in CG. The Braden Scale score in the IVG declined from 12.45±0.50 to 11.75±1.13. Statistically significant improvements were observed in Braden scores between day 1 and day 3 (IVG: x̄= -0.28±0.55, t= -3.14, p <0.05; CG: x̄= -0.58±4.69, t= -4.66, p <0.05) and between day 1 and day 8 (IVG: x̄= -0.70±1.07, t= -4.15, p <0.05; CG: x̄= 1.38±1.58, t= -5.50, p <0.05).</p><p><strong>Discussion: </strong>The findings underscore the clinical benefit of incorporating topical olive oil into standard PI preventive care. The significant reduction in PI prevalence and improved Braden Scale scores suggest olive oil's potential role as a protective agent due to its anti-inflammatory and antioxidant properties. These results align with existing literature on natural oil-based interventions for skin integrity. However, limitations include the small sample size and short duration, warranting further large-scale studies.</p><p><strong>Conclusion: </strong>Topical olive oil, when used alongside standard care practices, significantly reduced the incidence of pressure injuries in hospitalized, at risk patients. This approach could serve as a cost-effective, natural adjunct to PI prevention protocols, particularly in resource-limited healthcare settings.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144584708","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}

{"title":"Inter-rater Reliability and Accuracy of NBI Score for Activity Evaluation in Ulcerative Colitis.","authors":"Gianpiero Stefanelli, Marco Valvano, Annalisa Capannolo, Stefano Necozione, Angelo Viscido, Giovanni Latella, Michele Marchese","doi":"10.2174/0115748871367645250623062144","DOIUrl":"https://doi.org/10.2174/0115748871367645250623062144","url":null,"abstract":"<p><strong>Background: </strong>Colonoscopy is a critical tool for the management of Ulcerative Colitis (UC). In this study, we aim to explore the accuracy of Virtual Chromoendoscopy (VCE) using Narrow Banding Imaging (NBI), and magnification using Near Focus (NF) for a better definition of endoscopic inflammation grade in UC patients compared to standard white light (WL) endoscopy alone.</p><p><strong>Methods: </strong>This is a non-randomized prospective study including all the patients who underwent a colonoscopy (for any reason) between April and September 2023 (with protocol number n. 60/2019.20). During the endoscopic evaluation, at least one image with white light - evaluated using the Mayo Endoscopic Score (MES), one image with NBI, one image with NBI plus NF, and a biopsy were obtained in each colonic tract (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum). All the stored images were evaluated by three endoscopists separately and compared with the results of the histological evaluation.</p><p><strong>Results: </strong>A total of 31 UC patients were included. The inter-rater reliability concerning the different scores used (MES, NBI score, and NBI plus NF score), which was evaluated with Cohen's kappa coefficient, was good for the MES, good to excellent for the NBI score, and good for the NBI plus NF score. The concordance between histological evaluation (using the Nancy Index) and the MES was unsatisfactory for all the endoscopists, while the concordance between the NBI evaluation score and the Nancy Index was good to excellent.</p><p><strong>Conclusion: </strong>The results in the present study suggest that the new endoscopic technologies could be useful to better define disease activity in IBD patients driving better therapeutic strategy.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144576209","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}

{"title":"Evaluating the Impact of Lifestyle Interventions on Health Outcomes in Breast Cancer Survivors: A Systematic Review","authors":"Sana Jameel, Tuba Razi, Gulafshan Fatima, Abiha Ahmad Khan, Syeda Aamena Naaz, Hina Meraj","doi":"10.2174/0115748871357938250612102627","DOIUrl":"10.2174/0115748871357938250612102627","url":null,"abstract":"<p><strong>Introduction: </strong>Lifestyle interventions have been increasingly studied for their potential to improve health outcomes in breast cancer survivors. However, the relative effectiveness of these interventions remains unclear. This study aimed to evaluate the impact of various lifestyle changes on the health outcomes of breast cancer survivors.</p><p><strong>Methods: </strong>A comprehensive analysis of randomized controlled trials (RCTs) involving breast\u0000cancer survivors was conducted across major databases, including PubMed, Scopus, Embase,\u0000CINAHL, Cochrane Library, and ClinicalTrials.gov. Studies were selected based on their\u0000evaluation of lifestyle interventions aimed at reducing breast cancer risk and its recurrence and or\u0000improving survival. Non-RCTs and studies focusing solely on pharmacological or genetic\u0000interventions were excluded. The risk of bias in included randomized controlled trials was\u0000assessed using the Cochrane Risk of Bias 2 (RoB 2). The results of the included studies were\u0000presented in tabulated form.</p><p><strong>Results: </strong>Physical activity emerged as the most effective intervention, significantly enhancing\u0000metabolic health, body composition, and cardiorespiratory fitness. Dietary changes and weight\u0000management programs provided secondary health benefits, such as modest improvements in diet\u0000quality, metabolic markers, and quality of life. The combined intervention of diet and exercise\u0000further improved these outcomes although it did not significantly reduce cancer recurrence. The\u0000digital support system (EMPOWER-SMS) was feasible and acceptable, offering minor\u0000improvements in medication adherence and self-efficacy, though its effects on BMI and quality\u0000of life were less pronounced.</p><p><strong>Discussion: </strong>Among the various lifestyle interventions explored for breast cancer survivors,\u0000physical activity consistently emerged as the most effective in improving health outcomes. While\u0000dietary changes, weight management, and combined interventions also offered health benefits,\u0000their direct impact on key outcomes like cancer recurrence and survival was less clear. However,\u0000when integrated with regular exercise, these interventions contributed to holistic improvements\u0000in quality of life, making a combined approach potentially the most comprehensive for\u0000supporting breast cancer survivors. This systematic review's limitations include intervention\u0000heterogeneity, varied follow-up durations, inconsistent outcome measures, small sample sizes,\u0000lack of control over confounding variables, limited participant diversity, potential publication\u0000bias, and a focus on short-term outcomes.</p><p><strong>Conclusion: </strong>Physical activity emerged as the most beneficial lifestyle intervention for breast\u0000cancer survivors, particularly when combined with dietary modifications and weight\u0000management. A holistic approach that integrates physical activity, dietary changes, and digital\u0000support may provide the most comprehensiv","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144542065","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}

{"title":"Assessing the Efficacy of Small Molecule Drugs in Hutchinson-Gilford Progeria Syndrome: A Review of Clinical Trials.","authors":"Drishti Desai, Charmi Jyotishi, Suresh Prajapati, Reeshu Gupta","doi":"10.2174/0115748871373056250530040447","DOIUrl":"https://doi.org/10.2174/0115748871373056250530040447","url":null,"abstract":"<p><p>Hutchinson-Gilford Progeria Syndrome (HGPS), or progeria, is an exceptionally rare disorder characterized by premature aging. It is primarily caused by a c.1824C>T point mutation in exon 11 of the LMNA gene, though other rare pathogenic variants have also been reported. This mutation leads to aberrant splicing, producing a farnesylated mutant form of lamin A known as progerin. Progerin accumulates abnormally in the nuclear lamina, triggering numerous cellular dysfunctions, including nuclear deformation, disrupted proteostasis, endoplasmic reticulum (ER) stress, replicative stress, increased reactive oxygen species (ROS) production, impaired DNA endjoining repair, mitochondrial dysfunction, and cellular senescence. These disruptions collectively manifest as a multisystem disorder characterized by failure to thrive, accelerated atherosclerosis, and severe complications such as myocardial infarction, heart failure, stroke, and risks associated with head trauma or surgical interventions. Farnesyltransferase inhibitors (FTIs) have shown potential in mitigating disease phenotypes in preclinical models, with lonafarnib achieving FDA approval in 2020 as the first-and currently only-drug for progeria treatment. This review focuses on the clinical trial outcomes of small-molecule therapeutics for progeria, with particular emphasis on emerging small molecules from recent research. These novel compounds, with their unique mechanisms of action, hold promise not only for improving disease management but potentially offering a cure for this devastating condition.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507985","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}

{"title":"ICU Mortality Prediction Using XGBoost-based Scoring Systems: A Study from a Developing Country.","authors":"Reema Karasneh, Sayer Al-Azzam, Karem H Alzoubi, Mohammad Araydah, Dania Rahhal, Yamin Al-Azzam, Zelal Kharaba, Suad Kabbaha, Mamoon A Aldeyab","doi":"10.2174/0115748871348585250604065542","DOIUrl":"10.2174/0115748871348585250604065542","url":null,"abstract":"<p><strong>Background: </strong>Accurate mortality prediction in intensive care units (ICUs) is essential for enhancing patient outcomes and optimizing healthcare resource allocation. Traditional scoring systems, such as APACHE, APACHE II, and SAPS, have limitations in handling complex, high- -dimensional ICU data. In this study, multiple machine learning models were compared to establish an efficacious predictive model for mortality tailored explicitly to the Jordanian population and to explicate factors strongly associated with mortality.</p><p><strong>Methods: </strong>This study was conducted as a single-center, retrospective cohort investigation, and the XGBoost machine learning algorithm was used to develop a novel ICU mortality prediction model. The model aimed to achieve superior prediction accuracy using a diverse set of readily available clinical data, including demographics, comorbidities, laboratory results, and medication groups. Model performance was evaluated against alternative machine learning algorithms, including logistic regression, conventionally employed in traditional scoring systems.</p><p><strong>Results: </strong>Comparative analysis revealed that the XGBoost model performed better than other scoring systems, manifesting heightened accuracy (87.91%), sensitivity (92.88%), and Area Under the Receiver-Operating Characteristic Curve (AUC-ROC) Score/Curve (94.29%). Notably, the patient's length of hospital stays, albumin levels, and urea levels emerged as the most substantial predictors for ICU mortality, each exhibiting respective SHAP values of 0.5, 0.41, and 0.37.</p><p><strong>Conclusion: </strong>A locally adapted ICU mortality prediction model was developed, underscoring the pivotal role of predictors such as hospital stay duration, albumin, and urea levels in predicting patient outcomes. The heightened accuracy and sensitivity of the XGBoost model signify its potential as an invaluable tool in the critical task of mortality prediction within the Jordanian ICU context.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144333805","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}

{"title":"Impact of Brexit on Pharmaceutical Regulations: EMA vs. MHRA.","authors":"John Giridharan Ivr, R Srinivasan","doi":"10.2174/0115748871375964250531090843","DOIUrl":"https://doi.org/10.2174/0115748871375964250531090843","url":null,"abstract":"<p><strong>Introduction: </strong>Brexit has significantly altered the regulatory landscape for pharmaceuticals, with the UK no longer under the European Medicines Agency (EMA). The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has since developed independent regulatory frameworks, introducing challenges for companies operating in both regions.</p><p><strong>Methods: </strong>A qualitative approach was used, drawing on secondary data from peer-reviewed literature, official EMA and MHRA documents, and government publications. Sources were selected based on relevance to post-Brexit regulatory changes in drug approval, clinical trials, and pharmacovigilance.</p><p><strong>Results: </strong>The MHRA has implemented distinct procedures, including the UK Conformity Assessed (UKCA) mark, new marketing authorization pathways, and accelerated drug review routes. Regulatory divergence has necessitated dual submissions, separate clinical trial approvals, and independent safety reporting systems, increasing costs and complexity.</p><p><strong>Discussion: </strong>Despite shared safety objectives, the absence of harmonized processes complicates regulatory operations for pharmaceutical companies. The separation limits efficiency and may delay market access. However, international collaboration and the development of mutual recognition agreements offer potential pathways to reduce duplication and maintain alignment.</p><p><strong>Conclusion: </strong>Brexit has created a fragmented regulatory environment for pharmaceuticals in the UK and the EU. Companies must adopt flexible compliance strategies to manage dual frameworks. Continued dialogue and cooperation between regulatory bodies will be essential to safeguard patient access and support innovation across both jurisdictions.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144317820","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}

{"title":"Comparative Review of Clinical Trial Regulations in Different Countries: Current Scenario and Future Prospect.","authors":"Mansi Sharma, Manan Grover, Navneet Sharma, Vikesh Kumar Shukla, Shubham J Suryavanshi","doi":"10.2174/0115748871365320250529125930","DOIUrl":"https://doi.org/10.2174/0115748871365320250529125930","url":null,"abstract":"<p><strong>Introduction/objective: </strong>Clinical trial regulations (CTR) are essential for ensuring the safety, efficacy, and ethical conduct of drug development. However, the regulatory frameworks governing these trials vary significantly across different countries, affecting approval processes, trial conduct, and drug development timelines. This review examines the differences in clinical trial regulations in the USA, EU, Australia, and India between 2016 and 2024. The focus is on key regulatory aspects, such as the adoption of Good Clinical Practices (GCP), patient safety measures, and policies fostering innovation. By comparing drug regulations and trial management practices, it aims to identify regulatory challenges and propose improvements to enhance global harmonization.</p><p><strong>Methods: </strong>A detailed review of drug regulations, acts, rules, and trial processes across different countries was conducted. The review compared global standards for clinical trials, focusing on costs, safety reporting, and trial management, and identifying key areas for improvement.</p><p><strong>Conclusion: </strong>The findings reveal that while the studied countries have established strict regulatory frameworks, still there are specific areas for improvement. A key recommendation is to formally authorize Clinical Research Organizations (CROs) to enhance the quality and oversight of clinical trials. Additionally, specific regulations for herbal medicine trials are urgently needed to ensure safety and efficacy. Ethical concerns, especially regarding pediatric and orphan drug products, require more robust oversight. Integrating blockchain technology is also recommended to improve transparency and traceability in drug development. Finally, promoting global regulatory harmonization is crucial to minimize delays in patient access to essential therapies. These insights aim to guide policymakers, researchers, and stakeholders in enhancing the quality, safety, and accessibility of medicines.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144286363","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}

{"title":"A Review of Software in Clinical Trials: FDA Regulatory Frameworks and Addressing Challenges.","authors":"Simran Dixit, Deepti Sharma, Navneet Sharma, Vikesh Kumar Shukla","doi":"10.2174/0115748871359356250523033831","DOIUrl":"https://doi.org/10.2174/0115748871359356250523033831","url":null,"abstract":"<p><p>An essential tool for assessing the efficacy and safety of novel therapies and interventions is the clinical trial. They are crucial for understanding disease causes, treatment effectiveness, and patient care processes. However, traditional clinical trials often suffer from inefficiencies, high costs, and extended timelines. This review explores how artificial intelligence can revolutionize clinical trials by addressing these inefficiencies in trial design, patient recruitment, and data analysis. It also discusses the challenges and solutions for incorporating AI within existing regulatory frameworks. This review is based on a comprehensive analysis of the existing literature on artificial intelligence applications in clinical trials. It includes an evaluation of studies that assess the role of artificial intelligence in enhancing trial efficiency, optimizing patient recruitment, and improving data analysis. Special attention is given to regulatory considerations, with a focus on Food and Drug Administration (FDA) guidelines and their impact on artificial intelligence integration in clinical research. The successful integration of artificial intelligence into clinical trials has the potential to optimize procedures, enhance clinical judgment, and improve patient outcomes. Artificial intelligence can streamline patient stratification, accelerate trial timelines, and enhance data analysis accuracy. However, overcoming challenges related to interpretability, data privacy, and regulatory compliance is crucial. Collaboration between researchers, artificial intelligence developers, and regulatory bodies is essential to establish guidelines ensuring artificial intelligence innovations are safe and effective. Ultimately, artificial intelligence could transform clinical research and pave the way for more personalized healthcare solutions.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199948","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}