Journal of Clinical Trials and Regulations (e-ISSN: 2582-4422)

Guidelines for Data and Safety Monitoring in Clinical Research: From Protocol to Patient Protection

Vivek Kumar Tiwari — 2026-04-28

Clinical trials are crucial for determining the safety and effectiveness of medical products before they are approved for public use. The primary ethical and scientific considerations throughout the lifecycle of a clinical trial are participant safety and data integrity. Data and safety monitoring guidelines provide systematic guidelines for identifying, evaluating, and controlling potential risks in clinical research. This review emphasizes the major guiding principles of data and safety monitoring in various stages of clinical trials, such as the functions of the investigators, sponsors, and data and safety monitoring boards (DSMBs). It addresses key international and national regulatory directions provided by ICH, US Food and Drug Administration (USFDA) and European Medicines Agency (EMA) and gives some specific comments on DSMBs data and safety monitoring plan (DSMP). The focus is on good clinical practice, adverse event reporting, risk-based monitoring, and electronic data integrity. These guidelines result in ethical behavior, compliance with regulations and sound trial results. Altogether, efficient data and safety monitoring help to improve the protection of participants and increase the credibility of clinical research.

mRNA Vaccines and Therapeutics: Current Trends and Future Perspectives

Munnangi Vasanthi — 2026-01-31

mRNA vaccines and therapeutics have emerged as revolutionary tools in the fight against infectious diseases, notably during the COVID-19 pandemic, displaying extraordinary speed, effectiveness, and adaptability. This article examines the current trends in mRNA technology, highlighting improvements in vaccine creation including the deployment of mRNA-based COVID-19 vaccines and their subsequent success in global immunization efforts. The paper also examines the broadening therapeutic applications of mRNA, from oncology and genetic disorders to autoimmune diseases, and the technical innovations enabling these strides, such as lipid nanoparticle delivery systems and mRNA optimization. Furthermore, the article delves into the challenges faced by the field, including stability concerns, manufacturing scalability, and regulatory hurdles. The future of mRNA technology is examined, with an emphasis on its potential to transform personalized medicine, preventive healthcare, and global disease control. The integration of mRNA-based approaches into broader therapeutic and vaccination strategies is poised to redefine modern medicine, offering unprecedented flexibility in addressing both known and emerging health threats.

Winning the Off-Patent Game: Strategic Roadmaps for Successful Generic Launches – Role Played by Medical Affairs

Abhijit Trailokya — 2026-04-30

The shift of pharmaceutical molecules into the off-patent phase offers both a major opportunity and a complicated challenge in the Indian market. Although generic drugs are chemically the same as innovator products, their successful use relies heavily on physician trust, scientific credibility, and clear value delivery. In this situation, medical affairs becomes an important strategic function. It goes beyond just a supportive role; it actively influences the lifecycle of generic product launches. This article outlines a clear, step-by-step framework that highlights the role of Medical Affairs in the pre-launch, launch, and post-launch stages. At the pre-launch stage, Medical Affairs helps with go/no-go decisions by assessing the therapy area, analyzing unmet needs, and evaluating the molecule in detail. During the launch, it focuses on communicating scientific evidence, engaging stakeholders through CMEs (continous medical education) and advisory boards, and ensuring the molecule is positioned accurately in clinical practice. After launch, the focus shifts to generating real-world evidence, monitoring drug safety, supporting patient-centric initiatives, and managing lifecycle strategies. The paper also reinforces the value of therapy-specific strategies, given that acute therapies require different scientific engagement, whereas chronic therapies require more extensive outreach and adherence strategies. Furthermore, it underscores the increasing relevance of proactive evidence generation, patient education, and early planning for indication expansions and fixed-dose combinations, all of which are significant differentiators in a competitive world of generics. Overall, a structured, science-driven, and patient-centric approach by Medical Affairs is vital to deliver clinical acceptance, improved patient outcomes, and commercial success in the off-patent pharmaceutical industry.

Psychological Problems and Adverse Childhood Experiences among Sanitation Workers in India: An Ordinal Logistic Regression Analysis

Akanksha Chandele — 2026-04-01

Sanitation workers in India are a marginalized workforce group exposed to adverse working environments, social stigma, and socioeconomic insecurity. Nevertheless, scarce empirical interest has been devoted to the role of pre-adolescent hardships in determining their mental and behavioural consequences at adulthood. The paper will discuss how the Adverse Childhood Experiences (ACE) could affect the development of substance-related psychological issues in sanitation workers in India. The data were collected using the quantitative and cross-sectional design, where 1,418 sanitation workers in ten states in India were sampled with the help of a structured and interviewer-administered questionnaire. The cumulative ACE score was used to measure ACE exposure and the degree of psychological problems using three ordinal outcomes, frequency of alcohol/drug/tobacco use, lack of ability to control substance use and the neglect of personal/family responsibilities owing to substance use. The PLUM procedure in SPSS was used to estimate the ordinal logistic regression models. Findings of the bivariate models revealed that the higher ACE scores, the more substance use, loss of control, and neglect of duties. Adjacent models, which incorporated the sociodemographic variables as well as occupational variables, affirmed that the relationships were statistically significant and verified all the six hypotheses of the study. The results revealed that cumulative childhood adversity has a long-lasting effect on the psychological functioning of adults and especially among employees whose jobs are characterized by stigmatization and instability like manual scavenging. Although there are certain breaches to the proportional odds assumption, the trends and effect consistency demonstrate the strength of the findings. This research paper brings to the literature the extension of ACE research to a less studied population of occupational health workers in India, and the importance of occupational health policies and early prevention measures on long-term psychosocial risks in sanitation workers.