Perspectives in Clinical Research最新文献

Context: The "New Drugs and Clinical Trials Rules 2019" mandates that Ethics Committees (ECs) register with the Central Drugs Standard Control Organization (CDSCO), while ECs overseeing Postgraduate (PG) theses and academic studies must register with the Department of Health Research (DHR). National Accreditation Board for Hospitals and Healthcare Providers (NABH) accreditation of ECs is currently optional.

Aim: To evaluate the current status of EC registration and re-registration with CDSCO, DHR and accreditation of NABH as a metric of ethical oversight.

Subjects and methods: Data from January 1, 2019, to September 30, 2022 were collected from the organizational websites and the National Medical Commission (NMC). Registration and re-registration data for ECs were matched against the volume of studies in the Clinical Trials Registry India (CTRI), the number of ECs per state, and state populations. Descriptive and inferential statistics were applied.

Results: Of the 770 ECs registered with CDSCO, 38.3% were reregistered. Of the 977 DHR-registered ECs, only 17% were re-registered. Among 370 NMC-recognized PG medical institutes, 49.72% had DHR-registered ECs. Only 13% (186/1400) ECs were NABH accredited from the overall data. A total of 14,551 regulatory studies were registered with CTRI. Among the major states (>4% of Indian population), Maharashtra had the highest percentage of CDSCO-registered ECs at 20% and accounted for 14% of regulatory studies, while states such as Bihar and West Bengal had lower percentages of both CDSCO registered ECs and regulatory studies.

Conclusion: The registration, re-registration status of ECs, and accreditation are not commensurate with the quantum of regulatory and academic studies in the country.

Patient safety is crucial while using medical equipment, which is, therefore, strong risk management and monitoring systems such as materiovigilance are required. Through international cooperation and technical improvements, this field which focuses on identifying and resolving adverse occurrences related to medical devices has developed. By facilitating real-time data analysis and the early detection of safety issues, as well as by enhancing patient outcomes and regulatory compliance, the combination of artificial intelligence and machine learning has greatly improved materiovigilance. The Materiovigilance Programme of India attempts to improve the infrastructure for medical device monitoring in underdeveloped nations like India, in spite of obstacles including poor data quality and infrastructure. To improve the security and efficacy of medical devices, engineers, regulators, healthcare practitioners, and technology companies must continue to collaborate. To protect public health and safety, materiovigilance will increasingly rely on advanced technologies and strict adherence to regulations.

Drug repurposing, also known as drug repositioning or reprofiling, involves identifying new therapeutic uses for existing drugs beyond their original indications. Historical examples include sildenafil citrate transitioning to an erectile dysfunction treatment and thalidomide shifting from a sedative to an immunomodulatory agent. Advocates tout its potential to address unmet medical needs by expediting development, reducing costs, and using drugs with established safety profiles. However, concerns exist regarding specificity for new indications, safety, and regulatory exploitation. Ethical considerations include equitable access, informed consent when using drugs off-label, and transparency. Recent advancements include artificial intelligence (AI) applications, network pharmacology, and omics technologies. Clinical trials explore repurposed drugs' efficacy, with regulatory agencies facilitating approval. Challenges include intellectual property protection, drug target specificity, trial design complexities, and funding limitations. Ethical challenges encompass patient autonomy, potential conflicts of interest due to financial incentives for industries, and resource allocation. Future directions involve precision medicine, AI, and global collaboration. In conclusion, drug repurposing offers a promising pathway for therapeutic innovation but requires careful consideration of its complexities and ethical implications to maximize benefits and minimize risks.

Vitamin D supplementation studies in various pleiotropic outcomes often yield conflicting results. This complexity arises from various factors, including individual differences (baseline Vitamin D levels, genetics, ethnicity, age, and gender). This review aims to clarify the complexities in Vitamin D supplementation research by examining various influencing factors, ultimately providing a comprehensive understanding to guide future studies and offer more accurate insights into the health impacts of Vitamin D supplementation. For this review, we searched PubMed, Google Scholar, and ScienceDirect, analyzing observational studies, meta-analyses, and randomized controlled trials to identify key factors influencing the efficacy of Vitamin D supplementation. By synthesizing findings from diverse research, we aimed to illuminate the nuances shaping the outcomes of these trials. In conclusion, the review suggests that several demographic and biological factors such as baseline 25(OH)D levels, age, ethnicity, genetics, body mass index, diet, sun exposure, medications, comorbid conditions, socioeconomic status, and self-supplementation all play significant roles in the outcomes of Vitamin D supplementation trials. In addition, the dose and duration of therapy, choice of daily versus bolus dosing, route of administration, and the role of free and bound forms of Vitamin D contribute to the complexity of trial results. Vitamin D's pleiotropic effects extend beyond calcium regulation, impacting various health aspects. Inadequate blood levels can confound trial outcomes, emphasizing the importance of reaching appropriate 25(OH)D thresholds. Study design, sample size, bias minimization, and methodology are critical in influencing trial outcomes and designing studies that account for baseline levels and compliance is crucial for meaningful and accurate results. Standardized assays and internationally agreed-upon cutoff levels are essential to mitigate variability in 25(OH)D measurements and improve result reliability.

Context: One of the most frequent difficulties encountered in clinical trials is the failure to retain participants and this is doubly important when the disease is 100% fatal. Studies conducted during the COVID-19 pandemic regarding adherence have been equivocal.

Aims: The aim of this study is to compare participant adherence in a phase IV clinical trial for postexposure rabies prophylaxis before the pandemic, during lockdown, and after lockdown.

Settings and design: An observational study (audit).

Subjects and methods: The study in May 2023 covers the period from October 2019 to March 2022. Individual participant files of recruited participants were examined for adherence to treatment in the prepandemic period, during lockdown, and postlockdown eras.

Statistical analysis used: The primary outcome measure-participant adherence anti-rabies vaccination (ARV completion) in the three timelines was compared using the Chi-squared test. The secondary outcome measures: reasons for nonadherence and potential factors associated with it done by univariate followed by multivariate logistic regression. All analyses conducted at a 5% significance level.

Results: A total of 455 (2046 ARV visits) participants were recruited in the original Phase IV study, with a mean (±standard deviation) age of 31.9 ± 16.23 years. The COVID-19 lockdown reported the highest nonadherence to ARV (5/26, 19%) due to travel restriction and fear of contracting SARS-CoV2 infection compared to prepandemic (9/144, 6%) and postlockdown (6/285, 2%) periods.

Conclusion: There was a significant reduction in participant adherence for ARV completion during the lockdown compared to the prepandemic and postlockdown timelines. Decentralized Clinical Trials may offer potential solutions to improve adherence in the context of epidemics and pandemics.

Survival analysis (or time-to-event analysis) deals with data where the outcome of interest is the length of time until the occurrence of an event. This type of analysis is unique because the event may not occur in all participants (known as censoring). A previous article in this journal covered the basic aspects of conventional survival analysis. In this article, we discuss two unique features - nonproportional hazards (PH) and competing risks.