Reviews on Recent Clinical Trials - Online First

Clinical trial regulations 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. By comparing clinical trial regulations and trial management practices, this study aims to identify regulatory challenges and propose improvements to enhance global harmonization.

This review examines clinical trial regulations across the United States, European Union, Australia, and India, selected based on their diverse regulatory frameworks and global influence on clinical research. Literature screening was conducted using PubMed, Scopus, and official regulatory agency websites, focusing on publications from 2016 to 2024. Selection criteria included regulatory frameworks, amendments, ethical guidelines, and compliance measures related to clinical trials. The analysis covered key aspects such as trial approval timelines, safety reporting requirements, cost implications, and oversight mechanisms to identify regulatory challenges and potential improvements.

The findings reveal that although the studied countries maintain strict regulatory frameworks, they still exhibit gaps and inconsistencies. For instance, variations in approval timelines, safety reporting standards, and oversight mechanisms create inefficiencies and delays in drug development. It notes the absence of specific regulations for Clinical Research Organizations (CROs) authorization and herbal medicine trials in most regions.

Therefore, a key recommendation is to certify CROs to enhance the credibility of clinical trials. Additionally, specific regulations for herbal medicine trials are required to ensure safety and efficacy. Ethical concerns, particularly in pediatric and orphan drug research, demand more stringent oversight. The integration of blockchain technology is also proposed to improve accountability in drug development. Overall, promoting global regulatory harmonization is essential to minimize delays in patient access to essential therapies. These insights are intended to guide policymakers, researchers, and stakeholders in enhancing the quality, safety, and accessibility of medicines.

This review underscores the importance of consistent, transparent, and adaptable clinical trial regulations across global jurisdictions. While current frameworks demonstrate a commitment to ethical and scientific rigor, targeted reforms, such as CRO recognition, herbal trial regulation, and technology integration, are important for advancing clinical research. A harmonized regulatory landscape not only accelerates drug development but also ensures timely patient access to innovative and life-saving therapies.

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.

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).

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).

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.

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.

Radiotherapy for breast cancer has a clear benefit for long-term survival and local control rate. However, it can negatively impact a patient’s quality of life by affecting healthy surrounding normal tissues, including the heart and lungs. This study aimed to clarify the contribution of echocardiography with Global Longitudinal Strain (GLS) to early radiation-induced cardiotoxicity detection.

A prospective study was conducted on 25 early-stage left-sided breast cancer patients. All underwent 2D strain echocardiography before and one year after RT. Normality was assessed using the Shapiro-Wilk test and box plots. The Wilcoxon signed-rank test was conducted to compare GLS values. A statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 25.

Mean Global Longitudinal Strain value before and one year after radiotherapy was -20.2% and -21.2%, respectively. In half of these 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).

Although no statistically significant reduction in GLS was observed one year post-radiotherapy, a decrease was noted in patients receiving higher cardiac doses, suggesting potential early subclinical myocardial changes. Strain echocardiography shows promise as a sensitive tool for the early detection of radiation-induced cardiotoxicity, warranting further research with larger cohorts and extended follow-up.

While this small cohort study did not show significant GLS changes post-RT, it highlights the need for larger studies with longer follow-ups to confirm the role of strain imaging in identifying early cardiotoxicity in breast cancer patients.

Understanding the public perception of colorectal cancer screening is crucial since early diagnosis lowers mortality rates associated with this type of cancer.

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.

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.

The patient’s perspective on screening modalities is crucial to consider in national colorectal cancer screening programs. The future outlook for home-based fecal immunochemical Tests (FIT) may provide superior research regarding cost-effectiveness and adherence among patients compared to colonoscopy or medical facilities in FIT investigations.

More attention should be paid to the population’s preferred method of colorectal cancer screening, which could increase the success of the screening effort. Cultural and socioeconomic status might affect the generalizability of the study.