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Perspectives in Clinical Research
Scopus
ISSN 2229-3485 · Wolters Kluwer Medknow Publications · 692 artikel di indeks
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Artikel Jurnal
Efficacy and safety of topical phenytoin cream in diabetic foot ulcers: A randomized, open-label, parallel, and proof-of-concept study
Background: Diabetic foot ulcers (DFUs) are a severe diabetes complication, often leading to amputations. Despite medical advancements, no standard treatment exists. Conventional care is insufficient, prompting research into new therapies. Aims and Objectives: Phenytoin, an antiepileptic drug, has…
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Artikel Jurnal
Efficiency and effectiveness of concise evidence-based medicine training program at a tertiary healthcare institute – Exploring the impact on research output of faculty
Background: Many clinicians fail to incorporate principles of evidence-based medicine (EBM) while treating patients due to a lack of formal training in EBM. Faculty/clinicians lacking expertise in EBM skills cannot promote evidence-based practice in their students and residents. The present study…
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Quality of life in tuberculosis patients: A comparative study of video-observed therapy and directly observed therapy
Purpose: Tuberculosis (TB) is a chronic disease that negatively impacts the quality of life (QoL) due to the physical, emotional, and social challenges it poses. Digital technology has transformed the management of TB by improving patient outcomes and enabling more efficient and personalized care…
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Statistical approaches in ambispective cohort studies: Challenges and methodological insights
Ambispective cohort studies combine retrospective and prospective data collection to provide a comprehensive understanding of treatment outcomes over time. This hybrid design offers several advantages, particularly in real-world settings where long-term patient follow-up is essential. However…
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Lessons from global materiovigilance systems: What India can learn?
Medical devices are indispensable in modern healthcare, playing a crucial role in diagnosing, treating, and managing various medical conditions. While these devices offer significant benefits, they also pose potential risks due to defects, malfunctions, or adverse events, which can lead to serious…
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Impact of educational intervention on knowledge and awareness of good clinical practice among healthcare professionals at a tertiary care teaching hospital
Background: Good clinical practice (GCP) ensures ethical, as well as scientific quality of clinical trials, thus safeguarding participant safety and data integrity. The drug controller general of India mandates GCP training for healthcare professionals who conduct clinical research. However…
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Measuring quality of life in clinical research – Part 3
Health-related quality of life (HRQoL) is an important outcome in cancer research, as it captures the impact of disease and treatment on patients’ daily functioning and well-being. Building on earlier discussions of HRQOL concepts and measurement methods, this article focuses on HRQoL issues…
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Continuous review for ethical conduct of clinical trial-are the ethics committees complying?
Ethics committees (ECs) play a crucial role in safeguarding clinical trial participants through ongoing review beyond initial protocol approval. Although regulations require periodic monitoring of study progress, risk, protocol adherence, and informed consent processes, evidence from India…
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Assessment of the impact of a structured training program on knowledge of research methodology among anesthesiology trainees at a tertiary referral cancer center
Purpose/Aim: Knowledge of research methods is essential to appraise published literature and conduct good-quality research. Studies have shown that many postgraduate trainees lack adequate research knowledge. The aim of this study was to assess baseline knowledge of research methods and the impact…
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Surveillance of antimicrobial utilization among outpatient settings of a tertiary care hospital
Background: Antimicrobial stewardship programs typically focus on inhospital settings, with limited information available on the quality of antimicrobial use in hospital outpatient clinics. Given the significant volume of antibiotic consumption in outpatient settings, effective surveillance and…
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Stakeholder perspectives on ethical issues in genetic data reuse within clinical trials
Purpose: The ethical reuse of genetic data in clinical trials poses significant challenges, particularly concerning informed consent, data privacy, and governance on genetic data re-uses. Understanding stakeholder perspectives is essential to developing responsible and transparent practices in…
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Analyzing Subject Expert Committee meeting of minutes as a strategic metric for evaluating India’s clinical research trajectory
Background: In India, the Central Drugs Standard Control Organization (CDSCO) regulates drug, device, and cosmetics to support evidence-based decisions, and the Ministry of Health and Family Welfare established Subject Expert Committees (SECs) for drug approvals and clinical trials (CTs)…
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A prospective, observational study of efficacy and safety of desloratadine and bilastine in patients of chronic spontaneous urticaria
Purpose: Urticaria is a disease where there is development of short-lived itchy wheals (hives), angioedema, or both.[1] With a lifetime prevalence of up to 22%, it is a widespread skin disorder that affects the general population. Urticarial episodes lasting longer than 6 weeks are considered…
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Qualitative research – Part 2 – Choosing a research design
The previous article in this series provided an overview of qualitative research, how it compares and contrasts with quantitative research, and an introduction to qualitative research approaches and designs. In this article, we delve deeper into the process of choosing an appropriate qualitative…
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Artikel Jurnal
Quality of real-world registry studies
Registry studies are types of real-world studies (RWS), which are used to generate clinical evidence regarding therapeutic use, potential benefits, or risks of a medical product in real-world medical practice, and to support regulatory decisions. RWS are conducted using real-world data (RWD), which…