{"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}
{"title":"Polycystic Ovary Syndrome and Vitamin D Status - Impact of Vitamin D Supplementation on Insulin Resistance.","authors":"Shariq Rashid Masoodi, Khalid J Farooqui, Imtiyaz Ahmed Najar, Peerzada Ovais Ahmad, Sazal Patyar, Poonam Arora, Manish Kumar","doi":"10.2174/0115748871310723250516041347","DOIUrl":"https://doi.org/10.2174/0115748871310723250516041347","url":null,"abstract":"<p><strong>Background: </strong>Among premenopausal women, polycystic ovarian syndrome (PCOS) is one of the most ubiquitous endocrine and metabolic conditions. Abdominal adiposity, insulin resistance, obesity, metabolic diseases, and cardiovascular hazards are often associated with PCOS. This investigation aims to decipher the influence of oral Vitamin D3 supplementation (2000 IU/day for three months) on glucose metabolism in PCOS women.</p><p><strong>Methods: </strong>123 subjects (females 16 to 40 years of age) were arbitrarily allocated to three cohorts (n = 41 in each cohort) Each participant received two tablets daily and a sachet every month for three months (Group I: Vitamin D3 Tablets + placebo sachets; Group II: Placebo Tablets + Vitamin D3 sachets; Group III: Tablets + Placebo sachets).</p><p><strong>Results: </strong>Among 123 PCOS subjects, 93.4% exhibited hypovitaminosis D. The baseline 25- hydroxyvitamin D (25(OH)D) concentration of 13.76 (SD ± 10.61) ng/ml increased by 86.84% post-intervention. Groups I and II (active group) depicted substantial diminution in pre-treatment fasting and 2-h blood glucose, with no substantial change in the HOMA-IR. Group III (placebo) showed no improvement in vitamin D status or HOMA-IR. Overall, we observed no substantial HOMA-IR improvement with vitamin D subjunction. However, subgroup analysis revealed a statistically significant enhancement in HOMA-IR for subjects achieving a two-fold upsurge in post-supplementation 25(OH)D levels (≥ 20 ng/ml) compared to those without this increase (p = 0.025).</p><p><strong>Conclusion: </strong>Vitamin D3 supplementation improves glucose metabolism, as demonstrated by lower fasting and 2-hour blood glucose levels, but overall has no substantial repercussion on measures of insulin sensitivity like HOMA-IR. A larger vitamin D3 dose and an extended follow-up study are essential to comprehend the complex physiology of vitamin D and glucose homeostasis. The cohort's mean blood 25-hydroxyvitamin D concentrations were successfully boosted by 84% by Vitamin D3 dosage; yet, the influence on insulin resistance markers displayed a subtle complexity. A relationship was found amid the absolute variation in HOMA-IR and the percentage variation in Vitamin D. Nevertheless, there was no substantial general alteration in the mean HOMA-IR across different subgroups.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143291","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":"Colorectal Cancer Screening Modalities Among Saudi Population: Significant Predictors.","authors":"Mohammad Bukhetan Alharbi","doi":"10.2174/0115748871335743250417103659","DOIUrl":"https://doi.org/10.2174/0115748871335743250417103659","url":null,"abstract":"<p><strong>Introduction: </strong>Understanding the public perception of colorectal cancer screening is crucial since early diagnosis lowers mortality rates associated with this type of cancer.</p><p><strong>Methods: </strong>The purpose of this study was to determine the most popular technique for colorectal cancer screening in Saudi Arabia. From September 2021 to February 2022, a cross-sectional study on adult Saudi population was undertaken. Data were collected through a self-created survey distributed via an online platform.</p><p><strong>Results: </strong>Out of 10,781 participants analyzed, 5,612 were found suitable for evaluating preferences between colonoscopy and fecal immunochemical test (FIT) as screening modalities. It was found that gender, employment, and age were important predictors for the preferred screening modality.</p><p><strong>Conclusion: </strong>More attention should be paid to the population's preferred method for colorectal cancer screening, which could increase the success of the screening effort.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143264","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}
Vittorio Grosso, Francisca Bulai, Alice Cerato, Cristina Olivero, Irene Praticò, Eleonora Galli, Francesca Diana, Matteo Nicoletto, Alberto Grosso, Luigi La Via, Fulvio Pomero
{"title":"The Role of Anti-MDA5 Antibodies in Rapidly Progressive Interstitial Lung Disease: A Case Report and Literature Review.","authors":"Vittorio Grosso, Francisca Bulai, Alice Cerato, Cristina Olivero, Irene Praticò, Eleonora Galli, Francesca Diana, Matteo Nicoletto, Alberto Grosso, Luigi La Via, Fulvio Pomero","doi":"10.2174/0115748871350269250507052714","DOIUrl":"https://doi.org/10.2174/0115748871350269250507052714","url":null,"abstract":"<p><strong>Introduction: </strong>Anti-melanoma Differentiation-associated Gene 5 (aMDA5) antibody-associated Rapidly Progressive Interstitial Lung Disease (RP-ILD) is a rare and potentially fatal condition.</p><p><strong>Case presentation: </strong>This case report describes a 78-year-old male who presented with a 10-day history of fever, cough, and asthenia. Despite initial treatment for suspected atypical pneumonia, the clinical condition rapidly deteriorated, necessitating intensive care and mechanical ventilation. High-resolution CT scans revealed a progressive interstitial lung disease with pneumomediastinum. Autoimmunity blood tests revealed high-titer anti-MDA5 antibodies bringing to a diagnosis of anti-MDA5 RP-ILD. Despite aggressive immunosuppressive therapy, the patient's condition continued to worsen, resulting in death. Our case underlines the importance of early recognition and diagnosis of anti-MDA5 RP-ILD, as it can present without typical dermatomyositis skin manifestations. The report also includes a comprehensive literature review covering the pathogenesis, clinical manifestations, diagnosis, and treatment options for anti-MDA5-associated disease.</p><p><strong>Conclusion: </strong>This case underscores the need for increased awareness of this condition among clinicians to improve early diagnosis and treatment outcomes.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144080038","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}
Areti Gkantaifi, Christodoulos Papadopoulos, Maria Toumpourleka, Maria Marketou, Davide Mauri, Georgios Giakoumettis, Dimitris Mavroudis, Maria Tolia
{"title":"A Prospective Study on the Role of Strain Echocardiography in Detecting Early Radiation-induced Cardiotoxicity in Left-sided Breast Cancer Patients.","authors":"Areti Gkantaifi, Christodoulos Papadopoulos, Maria Toumpourleka, Maria Marketou, Davide Mauri, Georgios Giakoumettis, Dimitris Mavroudis, Maria Tolia","doi":"10.2174/0115748871338729250418152731","DOIUrl":"https://doi.org/10.2174/0115748871338729250418152731","url":null,"abstract":"<p><strong>Introduction: </strong>Breast cancer radiotherapy has a clear benefit for both long-term survival and local control rate. However, healthy surrounding normal tissues, including the heart and lungs, can negatively impact a patient's quality of life.</p><p><strong>Objective: </strong>This study aims to clarify the contribution of echocardiography with Global Longitudinal Strain to early radiation-induced cardiotoxicity detection.</p><p><strong>Methods: </strong>The sample of our prospective study consists of 25 patients with early-stage left-sided breast cancer. 2D strain echo was estimated on all patients before and one year after radiotherapy. For the control of the normality of the condition, the Shapiro-Wilk test and the study of graphical representation of the «Box Plot» were used. For the comparative analysis of average values of a continuous variable and between two-time points, the Wilcoxon test was used. SPSS 25 software was used for the statistical processing of the data.</p><p><strong>Results: </strong>Mean Global Longitudinal Strain value before and one year after radiotherapy was -20.2% and -21.2%, respectively. In half of the cases, the values ranged from -19.65% to -22.70% before radiotherapy and between -18.8% and -22.25% after radiotherapy. The non-parametric Wilcoxon test indicated no statistically significant difference before and after radiotherapy (Ζ =0.902, p = 0.367).</p><p><strong>Conclusion: </strong>Our study did not detect any significant difference in the mean Global Longitudinal Strain pre and post-radiotherapy. However, early radiation-induced cardiotoxicity diagnosis should be a priority throughout the treatment process, requiring further studies with a larger sample size and a longer follow-up to find valuable tools to minimize the side effects of therapeutic manipulations.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014925","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":"Thyroidectomy Complications after Ligasure Small Jaw Use, Case Series, Prospective Study.","authors":"Mohammad Bukhetan Alharbi","doi":"10.2174/0115748871336355250420013730","DOIUrl":"https://doi.org/10.2174/0115748871336355250420013730","url":null,"abstract":"<p><strong>Introduction: </strong>The Ligasure small jaw (LISJ) is believed to provide several benefits for thyroid surgery. The use of LISJ by non-expert surgeons or those who erroneously assume its extensive usage can reduce postoperative bleeding may, in reality, pose a considerable risk of additional severe consequences.</p><p><strong>Material and methodology: </strong>Between March and December of 2022, I analyzed complications following total thyroidectomy (TTH) case series for 10 patients who underwent surgery for papillary thyroid cancer by one qualified surgeon using LISJ. Cohorts were evaluated prospectively including hypocalcemia (HC) and recurrent laryngeal nerve (RLND) palsy.</p><p><strong>Results: </strong>All 10 patients experienced postoperative hypocalcemia (HC), necessitating a postoperative calcium supplement with vitamin D. One patient suffered stridor after extubation.</p><p><strong>Conclusion: </strong>The Ligasure Small Jaw serves as an effective hemostatic device, but it requires more attention in complete thyroidectomy. During a complete thyroidectomy, the Ligasure Small Jaw's lateral heating action may affect delicate structures more often than reported. Such damage could lead to hypocalcemia, which could be temporary or permanent, and recurrent laryngeal nerve palsy. More research would provide greater insights into the anticipated complication rates, particularly when conducted by less experienced specialized surgeons.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144045539","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 Quality of Methodological Reporting of Randomised Controlled Trial (RCT) Articles Published in Iranian and Top Nursing and Midwifery Journals Indexed in the Scopus Database using the CONSORT Checklist: A Cross-sectional Study.","authors":"Razieh Bagherzadeh, Siavash Asadzadeh Jahanabad, Leila Dehghani","doi":"10.2174/0115748871331785250415055616","DOIUrl":"https://doi.org/10.2174/0115748871331785250415055616","url":null,"abstract":"<p><strong>Background: </strong>The quality of methodological reporting of randomised controlled trials (RCTs) is an important consideration in the use of RCTs for guiding healthcare decisions; however, in recent years, the quality of reporting has been examined from a more methodological perspective. The current study seeks to compare the methodological reporting of randomized controlled trial (RCT) articles published in Iranian nursing and midwifery journals indexed in Scopus with that of RCT articles published in nursing and midwifery journals indexed in the Scopus database, utilizing the CONSORT checklist as a framework for evaluation.</p><p><strong>Method: </strong>The current study is a comparative cross-sectional study. RCT articles from eight Iranian Scopus-indexed journals (381 articles) and three of the journals with the highest CiteScore index (204 articles) were reviewed. The study was conducted during 2017-2021. The data collection utilized the methodology section of the CONSORT checklist, which comprises 17 items and incorporates a two-dimensional scoring system with a score range of 0 to 17. SPSS 19 software was used for data analysis.</p><p><strong>Results: </strong>The average percentages of the methodological reports published in the top three Iranian journals, indexed in the Scopus, were 76.4% and 84.4%, respectively. Also, the mean quality score of methodological reporting of RCT articles published in Iranian nursing and midwifery journals was significantly lower than the mean score of methodological reporting of RCT articles in international nursing and midwifery journals indexed in the Scopus published from 2017-2021 (P <0.001). In some cases, such as items related to randomisation and blinding, there was under-reporting in both groups of journals.</p><p><strong>Conclusion: </strong>The results of the research showed that the average quality of the methodological report in most cases of CONSORT statements in Iranian journals is lower than that of the top three Scopus journals. Journals with lower reporting quality scores, such as Iranian journals, can improve the quality of their articles by following reporting guidelines for all types of articles, including RCT articles.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009165","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":"Transformative Paths: Preclinical Drug Formulation and Delivery Approaches in Development.","authors":"Deepshi Arora, Anjali Sharma, Prabhjot Kaur, Vishnu Mittal, Moin, Yugam Taneja, Devkant Sharma","doi":"10.2174/0115748871340281250331180316","DOIUrl":"https://doi.org/10.2174/0115748871340281250331180316","url":null,"abstract":"<p><p>This comprehensive review explores the multifaceted landscape of preclinical drug development, encompassing crucial stages, regulatory intricacies, Investigational New Drug (IND) submissions, and innovative formulation strategies. Delving into preclinical studies, the review underscores the importance of pharmacokinetics, pharmacodynamics, and safety assessments in animal models. Regulatory requirements governing preclinical studies are dissected, emphasizing compliance with global health authorities. The article provides a detailed examination of the IND submission process, elucidating essential components and documentation required for regulatory approval that are pivotal for advancing to clinical trials. Additionally, the evolving realm of Preformulation strategies is scrutinized, highlighting new methods like nanotechnology, solid dispersions, and formulas based on cyclodextrin to enhance drug solubility, stability, and bioavailability. This comprehensive overview aims to guide researchers, pharmaceutical professionals, and regulatory specialists through the complexities of preclinical development, offering insights into the latest formulation advancements from a legal point of view, making it be easy for potential drugs to go from lab to patient's bedside.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980888","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}
Virendra S Gomase, Arjun P Ghatule, Rupali Sharma, Satish Sardana
{"title":"Cybersecurity and Compliance in Clinical Trials: The Role of Artificial Intelligence in Secure Healthcare Management.","authors":"Virendra S Gomase, Arjun P Ghatule, Rupali Sharma, Satish Sardana","doi":"10.2174/0115748871366467250413070850","DOIUrl":"https://doi.org/10.2174/0115748871366467250413070850","url":null,"abstract":"<p><p>Rapid healthcare digitization has created both previously unheard-of potential and serious data management weaknesses, especially in clinical trials. Artificial Intelligence (AI) offers innovative approaches to enhancing cybersecurity and ensuring legal compliance in healthcare systems. Protecting private information from internet threats is more crucial than ever because clinical trials are increasingly reliant on patient data, electronic health records, and realtime monitoring devices. This study reviews how AI might strengthen cybersecurity procedures in clinical trial setups. Data breaches and unauthorized access are significantly reduced when AIdriven technologies are used for real-time threat detection and response. These systems create a dynamic defense mechanism that traditional security measures lack by continuously adapting to changing cyber threats using machine learning algorithms. In addition to cybersecurity, AI improves adherence to healthcare laws like GDPR and HIPAA by automating data processing procedures. AI protects patient confidentiality and data integrity by ensuring that clinical trials follow stringent regulatory criteria through intelligent automation. Additionally, AI helps detect and control compliance issues, relieving human monitoring and boosting productivity. Additionally, the study addresses the difficulties in applying AI in clinical trials, including the requirement for transparent algorithms and the possibility of bias in AI judgment. However, AI has the capacity to completely transform safe healthcare administration with the correct legislation and ethical guidelines. In conclusion, artificial intelligence (AI) is a vital tool for guaranteeing the confidentiality and legal compliance of medical data in addition to using it to increase clinical trial efficiency. The use of it offers a path forward in terms of the complexities of modern clinical trial cybersecurity. AI's automation and intelligence will lower risk and increase trial speed and accuracy by assisting clinical trial administrators and sponsors in navigating the complicated world of cybersecurity and compliance.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144054187","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}