Perspectives in Clinical Research

PURPOSE: Bilastine is a novel second-generation antihistaminic. Very few studies in Indian population have compared the safety and efficacy of bilastine with other second-generation antihistaminic like cetirizine. Hence, the present study was planned. MATERIALS AND METHODS: This was a randomized, open-label comparative parallel group study conducted on 70 patients of chronic spontaneous urticaria (CSU). Patients either received cetirizine 10 mg or bilastine 20 mg once daily for 6 weeks...

Evidence generated by randomized controlled trials (RCTs) does not often represent the patient journey and clinical outcomes in the real world due to limited external validity or generalizability. Studies based on real-world data are intended to generalize results to the broader population; however, if the influence of external factors or confounders is not effectively managed, the cause-and-effect relationship and internal validity may be challenged, resulting in flawed results. The collection of quality real-world evidence (RWE) is crucial in Asia as there is often an underrepresentation of Asian populations in RCTs...

No abstract text is available yet for this article.

Cannabis is one of the world's oldest cultivated plants and the most commonly used recreational drug worldwide. The plant relevant for medicinal use is Cannabis sativa that has two pharmacologically active ingredients - delta-9-tetrahydrocannabinol that is psychoactive and cannabidiol that does not have psychotropic activity. The policy tapestry of Cannabis has undergone a significant change in the past few decades worldwide. Different countries have diverse policies, ranging from classifying use of Cannabis as illicit, to legalization of its use, both for medicinal and recreational purposes...

BACKGROUND: Global evidence-based recommendations for hypertension management are periodically updated, and ensuring adherence to the guidelines is imperative. Furthermore, the current high prevalence of hypertension effectuates a high health-care cost. PURPOSE: To evaluate the prescribing patterns of antihypertensive drugs and other factors affecting blood pressure (BP) with the objective of assessing the proportion of patients achieving the target BP and to perform a pharmacoeconomic analysis in a South Indian population...

Questionnaires are often used as part of research studies to collect data from participants. However, the information obtained through a questionnaire is dependent on how it has been designed, used, and validated. In this article, we look at the types of research questionnaires, their applications and limitations, and how a new questionnaire is developed.

CONTEXT: Ethics committees (ECs) work toward upholding rights, dignity, safety, and well-being of research participants. They are also tasked with conducting oversight pre- and post-approval. ECs face various challenges in their functioning. Post-approval oversight is one of the major challenges, and various studies have stressed the importance of post-approval oversight. AIMS: The aim of this study was to explore the challenges in the post-approval processes that are faced by the ECs and to suggest solutions to the most common challenges...

CONTEXT: Clinical study for immunity. AIMS: The present study aimed to assess the effect of proprietary polyherbal formulation (PPHF), labelled as Kofol immunity tablets (KIT) on innate and adaptive immune responses in healthy individuals, on the backdrop of COVID-19 pandemic. SETTINGS AND DESIGN: Single-blind, randomized, placebo-controlled, exploratory study in institutional setting. MATERIALS AND METHODS: Post Ethics Committee permission, screened healthy individuals of either sex aged 18-35 years were randomized to PPHF/Placebo for 2 months...

No abstract text is available yet for this article.

BACKGROUND: Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time. AIM: This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the Indian Council of Medical Research [ICMR]) of informed consent coupled with online surveys...

INTRODUCTION: Since June 15, 2009, clinical trial registration in the Clinical Trial Registry-India (CTRI) has been made mandatory by the Drugs Controller General of India to improve transparency, accountability, conform to accepted ethical standards and reporting of all relevant results of registered trials. In this study, we planned to evaluate the compliance of Indian and global sponsors with clinical trials conducted in India in terms of reporting of clinical trial results at the CTRI...

INTRODUCTION: The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants. METHODS: Queries received after the initial review and replies sent by a single research department were evaluated. A content analysis was done to identify the domains and categories of queries. We categorized these queries as administrative, ethics related, and scientific...

OBJECTIVES: The objective of this study was to analyze antibiotic prescribing patterns in pediatric outpatients in a tertiary care teaching hospital in Eastern India, to identify use of World Health Organization (WHO) access, watch and reserve (AWaRe) antibiotics and to identify rationality of prescribing on the basis of WHO core prescribing indicators. MATERIALS AND METHODS: Scanned copies of prescriptions were collected from the pediatrics outpatients and antibiotic utilization pattern was analyzed in reference to WHO AWaRe groupings and core prescribing indicators...

No abstract text is available yet for this article.

Real-world data, routinely collected from multiple sources outside typical clinical research settings, are useful in conducting real-world studies. Sub-optimal and inconsistent data quality is a challenging issue which should be addressed whilst planning and conducting real-world studies. This brief review discusses the quality aspects of data needed for RWS.

BACKGROUND: Physicians, residents, interns, pharmacists, and nurses, as major health-care providers, bear a great deal of responsibility for reporting adverse drug reactions (ADRs). Resident doctors are the backbone of health-care system; hence they play a significant role in detecting and reporting ADR, particularly for hospitalized patients, as they are in contact with a patient and available round the clock. AIMS AND OBJECTIVE: Hence, the purpose of this study was to assess the knowledge, attitude, and practice (KAP) regarding Pharmacovigilance among resident doctors and to improve reporting of ADR by training resident doctors for filling the ADR reporting form...

The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the provision of the expedited approval pathways, i.e., "Emergency use authorizations" and "Conditional marketing authorizations," respectively, to give approval to novel therapeutics agents during emergency situations. India, firstly formalized the accelerated pathway named "Accelerated Approval Process" as per the New Drugs and Clinical Trials rule 2019 to address unmet medical needs that was implemented by the Central Drug Standard Control Organization to approve the novel therapeutics agents during COVID-19...

BACKGROUND: The 1983 US Orphan Drug Act provided impetus for the development of new therapies for rare diseases. Several studies focused on the number of orphan designations over time. However, very few focused on clinical trials that lead to their approval, particularly for infectious diseases. MATERIALS AND METHODS: All new drug approvals (orphan and non-orphan) by the US Food and Drug Administration (FDA) from January 2010 to December 31, 2020, were identified and details of approvals were taken from the US-FDA labels and summary reports for each drug...

No abstract text is available yet for this article.

INTRODUCTION: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often missed. Current guidelines expect ECs to detect, report and recommend suitable actions such that research participants' risks and harms are mitigated, to the extent possible. OBJECTIVE: Yenepoya Ethics Committee-1 conducted an internal audit of ongoing postgraduate dissertations involving human participants to assess the occurrence of PD/PVs...