Perspectives in Clinical Research

AIM: This analysis was conducted to review the number, and describe the characteristics of first-in-human (FIH) Phase 1 clinical trials registered in India from 2008 to 2022. MATERIALS AND METHODS: The data were extracted from the Clinical Trials Registry - India database for all FIH Phase 1 clinical trials registered between 2008 and 2022. Early-phase trials that were not FIH trials (e.g., pharmacokinetic studies and drug-drug interaction studies) were excluded from the study...

Informed consent is a foundation of the ethical conduct of research involving human participants. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that participants are aware of the risks and potential benefits and make a voluntary decision about participating in clinical trial research. The extraordinary scientific advances happening globally, have demonstrated the potential of regenerative therapies in transforming the health of the nation by providing a therapeutic option for diseases that were previously considered incurable...

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No abstract text is available yet for this article.

CONTEXT: Type 1 diabetes mellitus (T1DM) is a chronic disease, mainly observed in children or youth, with a significantly increased incidence in young children. Structured therapeutic patient education (TPE) is a must to help them manage their disease effectively and lead a healthy lifestyle. AIMS: This study aimed to assess the effects of a structured TPE program on glycemic markers and quality of life (QOL) of T1DM children and adolescents in Fez city, Morocco...

Decentralized clinical trials (DCTs) are gaining momentum in clinical research as these studies can be executed remotely through telemedicine and mobile/local health-care providers. The COVID-19 pandemic has further accelerated advances and adoption in this area. In the past few years, there has been significant development and growth in the use of remote data that are electronically transmitted from a clinical trial (CT) participant, from outside the clinical setting, to a data repository. Such data may include laboratory data, safety data, or outcome measures reported by the participant, the clinician or the observer...

Validity and reliability refer to the accuracy and consistency of a research tool. In the previous article in this series, we examined the development of a research questionnaire. In this article, we discuss the methods of determining the validity and reliability of a research questionnaire.

AIM: To assess the perception and practices on COVID-19 vaccination and to determine the predictors of booster dose acceptability among health-care workers (HCWs) in South India. MATERIALS AND METHODS: We conducted an anonymous cross-sectional survey on the perception and practices on COVID-19 vaccination and booster dose acceptability among the HCWs in South India. We prepared an online self-administered validated questionnaire, and the Google form link to it was circulated from March 28, 2022 to April 27, 2022, in the social media groups of the HCWs...

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PURPOSE AND AIM: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. SUBJECT AND METHODS: The study was conducted as a retrospective audit...

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Electronic health records (EHRs) constitute vital statistics, current health condition, ongoing therapies, and patient data; hence, their interoperability could be useful for epidemiologic and clinical research. Fast Healthcare Interoperability Resources (FHIR) and blockchain are currently "in-use" and tested for exchange of such data. The annual scientific production of publications for both FHIR and blockchain shows steady growth. The data interoperability and electronic data interchange have been introduced in the field of EHR in 2020, hence inferring that data interoperability is relatively a new domain...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

The International Council for Harmonisation has released a draft version E6(R3) of the Good Clinical Practice Guideline for public consultation. The objective of the revamped guideline is to make the new provisions applicable across diverse clinical trial types and settings and to remain relevant as technological and methodological advances occur. E6(R3) includes profound changes in the structure and content of E6(R2) version, which will impact all the trial conduct processes from planning to reporting. This guideline's focus on principles, digital technology, ethics, and quality will increase the responsibilities of the ethics committees, the investigator, and the sponsor...

Virtual clinical trials refer to clinical trials that take advantage of digital technologies, including computer and mobile device apps, web-based tools, and remote monitoring devices, for one or more of the trial processes, such as participant recruitment, counseling, informed consent, measurement of endpoints, and/or adverse event monitoring, to obviate or reduce the need for participant visits to the trial site. The advantages of such trials may include higher recruitment rates, better compliance, lower dropout rates, reduction in time for trial completion, and lower costs...

BACKGROUND AND OBJECTIVES: Evidence-based medicine (EBM) promotes the integration of updated- best evidence with patient preferences and medical expertise for clinical decision-making. Despite the availability of high-quality evidence such as systematic review and meta-analysis, some clinicians manage their patients based on past experiences and expert opinion. Thus, this study was proposed to assess the knowledge, attitude, and practice of EBM among resident doctors at a tertiary care hospital in India...

INTRODUCTION: In 2019, the Central Drugs Standard Control Organization (CDSCO) introduced the New Drugs and Clinical Trials Rules 2019 (NDCTR), which separated the research guidelines for "Clinical Trials" and "Biomedical and Health Research." As a result, guidelines issued by Indian Council of Medical Research were stated to apply to academic clinical trials (ACTs). This change is important because academic studies are crucial for scientific advancement and repurposing of approved drugs in health-care industry...

AIMS: This study was performed to understand the Indonesian population's characteristics and the factors that contribute to a more positive attitude toward participation in a clinical trial. METHODS: A cross-sectional survey was conducted involving 402 COVID-19 vaccine trial participants in Semarang, Indonesia, utilizing self-reporting questionnaires consisting of questions related to socio-demographic characteristics and statements in a 5-scaled Likert Scale to assess the attitude toward vaccine trial...