Perspectives in Clinical Research最新文献

Purpose: Allergic rhinitis (AR) is a type 1 allergic disease of the nasal mucosa, characterized by paroxysmal repetitive sneezing, watery rhinorrhea, and nasal blockage with the prevalence of 25% worldwide. Bilastine is a newer second-generation H1 antihistaminic approved for the symptomatic treatment of AR and chronic urticaria in patients older than 12 years. To date, there are very few studies in the Indian population comparing the efficacy, safety, and its effect on cognition of bilastine with second-generation antihistaminics. Hence, the study was planned to assess and compare the efficacy, tolerability, and the effect on cognition of cetirizine and bilastine in patients of AR.

Aim: The aim is to assess and compare the efficacy and tolerability of cetirizine and bilastine in patients with AR.

Materials and methods: It was a randomized, open-label, parallel-group, comparative study conducted on 80 patients of AR attending the ENT outpatient department of a tertiary care teaching hospital. Patients were divided into two groups of 40 each. They received either cetirizine 10 mg or bilastine 20 mg once daily for 2 weeks, and efficacy and tolerability were assessed at 2 weeks follow-up visits.

Results: The difference in mean total symptom score was significant in bilastine as well as cetirizine, which showed that bilastine was equally efficacious as cetirizine. Adverse events were reported more in the cetirizine group.

Conclusion: Bilastine is equally efficacious as cetirizine and a favorable tolerability profile may make it a more tolerable H1-antihistaminic than cetirizine.

Introduction: Several fixed-dose combinations (FDCs) have been available for the treatment of allergic rhinitis (AR), of which montelukast and levocetirizine is one of the highly prescribed FDC. The FDC of bilastine with montelukast was approved by the drug controller general of India (DCGI) in March 2020. Due to the availability of limited evidence, the present study was planned to evaluate and compare the effectiveness, safety, and cost-effectiveness of montelukast/bilastine versus montelukast/levocetirizine in relieving symptoms of AR.

Methodology: After getting approval from the Institutional Ethics Committee, a prospective, open-label comparative study was conducted from March 2024 to September 2024 at the Research Institute of Central India. Patients of either gender, in the age group of 18-65 years suffering from AR having total nasal symptom score (TNSS) >8 were enrolled. Selected patients were randomly assigned to Group A (montelukast-bilastine) or Group B (montelukast-levocetirizine) for 4 weeks.

Results: TNSS score was significantly reduced in Group A (χ ² = 62, df-2, P ≤ 0.001) and Group B (χ ² = 60, df-2, P ≤ 0.001) at week 2 and week 4 when compared with baseline. Comparative analysis of reduction in TNSS at 4 weeks among two groups shows no significant difference (P = 0.86). When analyzed by Fisher's exact test, the incidence of adverse events was significantly higher in Group B than in Group A (P = 0.04). The cost-effectiveness ratio in Group A was (518/8.22) 63.01 and in Group B was (616/8.33) 73.94.

Conclusion: Montelukast/bilastine and montelukast/levocetirizine are effective in managing AR. However, montelukast/bilastine offers a better safety profile and is more cost-effective, making it a viable option for AR treatment.

Current amended New Drugs Clinical Trials 2019 rules have simplified and streamlined regulatory processes that allow investigators to conduct investigator-initiated studies without central licensing authority approval unless directed by the Ethics Committee. Regulatory delays, funding constraints, and lack of collaboration still hinder investigator-initiated clinical trials (IICTs) to improve patient outcomes and healthcare practices. IICTs are important for addressing local health issues which are beyond the scope of pharma-sponsored research. In this paper, we outline a step-by-step approach for establishing a dedicated Biomedical and Health Research Unit (BHRU) even in resource-limited environments (financial and infrastructural limitations) that provides the necessary support to investigators, covering every aspect from research design to publication. The paper describes the practical approach of developing team comprising lead researchers, core medical writers, and trained statisticians. BHRU conducted research activities while ensuring investigators were relieved of administrative burdens. To enhance research proposal submissions, we developed a comprehensive database of investigators, research areas, and funding agencies. The development of a comprehensive publication database not only facilitated the archival of our publications but also helped to track manuscript submissions to journals. Published papers influenced changes in clinical practice in our hospital. To ensure required patient enrolment, BHRU implemented proactive recruitment strategies, such as an in-house patient database, and prescreening logs. To equip investigators with essential skills for conceptualizing protocols and adopting appropriate research methodologies, we established in-house training programs and external workshops. To reduce administrative and operational challenges in collaborations, BHRU acted as a centralized point of contact. Understanding that most of the government funding agencies requirement, we planned and acquired Scientific and Industrial Research Organization accreditation.

Introduction: Treatment adherence is crucial in management of chronic heart failure (HF) to prevent complications (hospitalizations). Patient awareness toward drug treatment is essential to ensure adherence. In addition, there is tendency to self-medicate which can be hazardous in these patients. The present study was planned to evaluate drug treatment awareness, patient tendency to self-medicate and prescription patterns in chronic HF patients.

Methodology: A cross-sectional, single-center, questionnaire-based study was conducted in the cardiology outpatient department of a tertiary care hospital from April 2021 to November 2022 after obtaining institutional ethics committee permission. Consented patients aged >18 years of either gender with confirmed diagnosis of chronic HF on stable drug treatment were included. Current prescription details were recorded, subsequently patients were administered a prevalidated drug treatment awareness (11-item, score-11) questionnaire and self-medication practice (12-item) questionnaire.

Results: Two hundred and fifty-six HF patients were enrolled and the overall mean treatment awareness score was 5.06 ± 1.77 and content accuracy was poor for names of the prescribed drugs (58/256,23%), dose/frequency (20/256, 8%) and adverse effects (0). Fifty-one percent HF patients indulged in self-medication practices with most common self-medicating drugs being analgesics. The average number of drugs/encounter was 5.95 ± 1.12 and most common class was beta-blockers.

Conclusion: Drug treatment awareness lacked in names, dose, frequency, and adverse effects of the prescribed drugs. Nearly 50% patients indulged in self-medication practices, maximum with analgesics. The most common drug class prescribed was beta-blockers (Metoprolol) followed by angiotensin converting enzyme inhibitors (Ramipril).

Context: Rabies is a neglected, vaccine-preventable, zoonotic, viral disease that affecting the central nervous system. Understanding its economic burden will aid in developing strategies to reduce mortality.

Aims: The aims of this study were to assess willingness to pay (WTP) for postexposure prophylaxis (PEP) for anti-rabies vaccination (ARV).

Setting and design: This was a a cross-sectional, interview based, pharmacoeconomic study.

Subjects and methods: After ethics approval and written informed consent, patients visiting the institute for PEP were enrolled and explained the bidding game strategy, and details of their socioeconomic strata (SES) were collected. Participants were asked regarding the WTP with a predecided starting bid amount of Indian rupees (INR) 2500/- for complete ARV. Based on their first response, this amount was either reduced or increased by INR 500/- until a final WTP reached. This was similarly done for travel and supporting medications.

Statistical analysis used: Both descriptive and inferential (regression) statistics were applied. WTP was taken as the dependent variable, whereas demographic and animal bite-related parameters were taken as independent covariates. All analyses were done at 5% significance.

Results: A total of n = 426 patients were enrolled. Of these, 255/426 (60%) patients were of Category III, whereas the remainder 171/426 (40%) were of Category II. Most of the patients (n = 306/426 [72%]-ARV, n = 270/426 [63%]-traveling and n = 277/426 [65%]-supporting medications) choose less than the bidding amount for all three aspects studied. Regression analysis showed that higher SES when the bite was from a dog and transdermal bites were significantly associated with a higher WTP.

Conclusion: Lower socioeconomic strata are associated with lower WTP. Although this is challenging to address, raising awareness about completing vaccinations is crucial, as rabies is 100% fatal once the central nervous system is affected and clinical symptoms appear.

Questionnaires play a crucial role in biomedical research, enabling valuable data collection from individuals. However, the effectiveness of a questionnaire depends on its ability to engage respondents and gather accurate information. This manuscript delves into the intricacies of crafting an effective questionnaire, exploring the essential elements that contribute to their success and impact, and highlights the need for well-crafted questionnaires in biomedical research emphasizing the importance of maximizing respondent engagement, obtaining reliable data, enhancing data completeness, minimizing nonresponse rates and bias, and facilitating data analysis. The article further sheds light on the factors influencing questionnaire effectiveness, including clear and concise language, logical flow and structure, relevance and significance, avoidance of double-barreled and leading questions, and using balanced response options and skip questions. This narrative review examines how each factor contributes to questionnaire quality and offers examples to illustrate their importance. Moreover, it emphasizes the significance of investing time and effort in designing effective questionnaires to ensure the validity and success of biomedical research. By understanding the art of engaging surveys, researchers can optimize their data collection processes and enhance the reliability and validity of their findings.

Purpose: Phase IV clinical studies are usually performed after a new drug obtains approval from a regulatory agency for marketing and use in the general population. There is not much information available on public platform regarding the types of contemporary Phase IV studies conducted in India. We aimed to determine the fundamental characteristics of Phase IV clinical trials using the Clinical Trials Registry-India (CTRI) registry data.

Materials and methods: A comprehensive search was undertaken for the total number of Phase IV studies registered between the inception of CTRI and May 2024. Information was analyzed based on the different characteristics of the registered study like year of registration, type of study, type of intervention, type of outcome, and type of sponsorship.

Results: Two hundred and thirty-eight studies fulfilling the inclusion criteria were included in the analysis. Twenty-nine (12.2%) of those were undertaken to assess only safety outcomes, 27 (11.4%) had only efficacy outcomes whereas a large number of studies (n = 182, 76.4%) were conducted to assess both safety as well as efficacy parameters. Almost 98% of the studies did not provide details of publication on the CTRI platform.

Conclusion: Although progress has been made in the conduction of clinical research in India, there is a need to conduct more Phase IV clinical studies and provide the details of their publication on the CTRI site to enhance credibility and transparency.

Background: On-site monitoring by the institutional ethics committee (IEC) is one of the most effective ways to ensure compliance during research conduct.

Objectives: The objectives of this study were to analyze the reports of clinical trial (CT) site monitoring conducted by IEC from January 2021 to March 2024 and to assess the impact of the monitoring by analyzing compliance reports submitted by the trial site team.

Methodology: A retrospective analysis of site monitoring and compliance reports was conducted after obtaining necessary approvals from IEC.

Results: The present study analyzed 22 reports of site monitoring conducted from 2021 to 2024. A total of 56 deviations were observed during monitoring. The most common deviations observed were related to documentation and record-keeping (31/56). In many cases, logs were incomplete (10/56). Traveling allowance (TA) was given but receipt was not maintained (4/56). Major observed were deducting expenses of consumables from TA, not giving TA and ICF was not signed and dated by patient/LAR. Based on monitoring report, query letters were sent to respective PIs with instructions to submit explanations and compliance reports. The PIs submitted compliance report mentioning CAPA in response to deviations pointed out by ethics committee monitoring team and submitted their reports to the IEC. The percentage improvement in ethical conduct of trials was 96.42%.

Conclusion: In the present study, active trial site monitoring helped the IEC to identify deviations that were impossible to identify by passive monitoring. Majority of deviations were resolved after being pointed out by IEC highlighting the importance of active monitoring. Thus, on-site CT monitoring is a critical aspect of ethical oversight, ensuring participant safety, maintaining data integrity and credibility, detecting compliance issues, and enhancing trust and transparency.

The use of artificial intelligence (AI) technology and machine learning (ML) is growing exponentially and is moving from AI to applied intelligence. Pharma industry is actively exploring the potential use of AI tools in new product discovery and clinical development. Some of the practical applications of AI in clinical development are for improving the efficiency of enrollment, selection and stratification of participants, optimizing study treatment, enhancing compliance, data analysis, and pharmacovigilance. AI applications have been used for outcome prediction; covariate selection/confounding adjustment; anomaly detection; real-world data phenotyping; imaging, video, and voice analysis; endpoint assessment; and pharmacometric modeling in regulatory submissions. However, widespread applications of novel yet difficult-to-understand AI technology in clinical development would need balancing the benefits and risks and resolving issues of scientific validity, technical quality, and ethics. The article discusses the potential benefits and emerging concerns of applying AI in clinical drug development.