Perspectives in Clinical Research最新文献

Background: Antibiotics are among the most commonly prescribed drugs. Unnecessary use of antibiotics is particularly concerning because antibiotics may be associated with a number of adverse drug events.

Aim: The study was designed to detect the association between pulmonary embolism and antibiotics by disproportionality analysis in the Food and Drug Administration database of Adverse Event Reporting System (FAERS) using data mining algorithms (DMAs).

Materials and methods: A retrospective case/noncase disproportionality analysis was performed in the FAERS database. This study was based on adverse events (AEs) reported to FAERS from 2004 Q1 to 2022 Q3. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) were applied to measure the disproportionality in reporting. A positive signal of increased AE risk was defined as ROR >1, Chi-square >4, PRR R2 with the number of cases >3, and IC >0.

Results: Total AEs in the FAERS database from 2004 Q1 to 2022 Q3 were found to be 26,555,430. Among which 80,809 reports of pulmonary embolism were considered. The same were selected for further analysis which showed that 11 antibiotics were reported for pulmonary embolism. The number of reports for minocycline, chloramphenicol, and moxifloxacin was found to be 113, 14, and 179. A significant potential signal was noted for minocycline (ROR - 2.87, Chi-square - 135.95, IC - 1.22), chloramphenicol (ROR - 3.35, Chi-square - 22.80, IC - 0.77), and moxifloxacin (ROR - 2.08, Chi-square - 99.37, IC - 0.83).

Conclusion: This study found a statistically significant increased risk of reporting pulmonary embolism with minocycline, chloramphenicol, and moxifloxacin, although a causal relation cannot be definitively established.

Stem cell research is a major focus for scientific and medical communities worldwide due to the potential for stem cells to restore function lost due to disease, trauma, congenital abnormalities, and aging. Stem cells can repair, replace, or regenerate damaged cells, tissues, or organs, making them an important area of research in regenerative medicine. India is emerging as a prominent hub for the development of stem cell therapy (SCT), and it is important to assess the current state of stem cell research in India and the potential for advancement to promote stem cell-based therapy. However, several barriers exist in India that are hindering the rapid expansion of SCT. This article examines the existing regulations that govern SCT in India, comparing them with regulations in developed nations, particularly for patients with unmet clinical needs. It also highlights the importance of public education in dispelling myths, addressing concerns, and promoting the benefits of stem cell research. The article concludes with recommendations for enhancing safety measures in SCT applications to ensure ethical practices and patient well-being.

Post-COVID-19, the emergence of newer technologies has taken center stage. One such technology is metaverse, which is an extension of existing technologies such as virtual reality (VR) and augmented reality (AR) that enables a fully immersive communication platform through the utilization of digital twins and avatars in a three-dimensional digital space. Literature review has shown that the adoption of such technologies in the field of clinical trials can help in improving the therapeutic outcomes in patients while having numerous other benefits. Despite its early stages of adoption, the application of metaverses in clinical trials through the use of AR, VR, and digital twins holds the ability to revolutionize key tasks in clinical trials, such as patient enrollment, engagement, monitoring, and counseling, by removing barriers to study participation. This review article focuses on the concepts of metaverse, its use in clinical trials, its inherent benefits, and limitations and serves as a starting point for clinical research organizations, pharmaceutical companies, and technology firms to conceptualize and develop metaverse solutions that stand to significantly benefit the broader landscape of clinical trials.

Introduction: Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same.

Methods: We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch-Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant.

Results: Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal-Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = -0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014).

Conclusion: Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance.

Previous articles in this series have looked at various aspects of planning, designing, conducting and interpreting biomedical research. In this article, we offer an overview of some tools and resources available to health and biomedical researchers, to help them with their research.

Purpose: To conduct a network meta-analysis comparing the safety and efficacy of gabapentin (GBP), pregabalin (PGB), oxcarbazepine (OXC), and duloxetine (DLX) in treating diabetic peripheral neuropathy (DPN).

Materials and methods: The study's eligibility criteria includee randomized controlled trials (RCTs) with a focus on DPN patients receiving GBP, PGB, DLX, or OXC versus placebo. Noncompliant trials with incomplete information and observational studies were excluded.

Results: Twelve (RCTs) of PGB, 2 of GBP, 3 of DLX, and 1 of OXC met the inclusion criteria. When drugs were compared for efficacy (direct comparison), GBP (Odd's ratio [OR] = 3.208, P < 0.001) was most effective followed by OXC (OR = 2.4, P = 0.0248), DLX (OR = 2.346, P < 0.001), and PGB (OR = 2.161, P < 0.001). When drugs were compared for withdrawal due to adverse drug reaction (ADR) (direct comparison), GBP (OR = 1.3818, P = 0.766) was safest followed by PGB (OR = 2.16, P < 0.001), DLX (OR = 2.469, P < 0.001), and OXC (OR = 4.4967, P = 0.001). Indirect comparison was done for efficacy, DLX was statistically significant than PGB and OXC (DLX vs. PGB, P = 0.03; DLX vs. OXC, P = 0.02). When indirect comparison was done for patient withdrawal due to ADR, OXC was worst (GBP vs. OXC, P = 0.0001; PGB vs. OXC, P = 0.007; DLX vs. OXC, P = 0.015). When drugs were compared for individual ADRs (direct comparison), dizziness was most commonly seen with OXC (OR = 9.6535, P = 1.8425), headache with OXC (OR = 3.8686, P = 0.006), somnolence with PGB (OR = 5.189, P < 0.001), and nausea with DLX (OR = 3.264, P < 0.001). GBP was most effective and safest drug followed by OXC > DLX > PGB for efficacy and PGB > DLX > OXC for safety.

Conclusion: In evaluating medications for DPN against placebo, GBP and OXC demonstrated the highest effectiveness while maintaining a favorable safety profile.