Comparative study of efficacy and safety of cetirizine and bilastine in patients of chronic spontaneous urticaria: Open-label, randomized, parallel-group study.

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. The primary endpoint was to find out the difference in the mean total symptom score (MTSS) at baseline and 6 weeks. The secondary endpoint was to find out changes in the scale of the number of wheals, change in pruritus scale, scale for size of wheal, change for interference of wheals with sleep, change in visual analog scale (VAS) for sedation, change in scale for intensity of erythema, and change in Scale for Extent of Skin Area Involvement (SESI). Results: Bilastine and cetirizine offer a significant reduction in MTSS, mean number of wheals, and mean pruritus scale at baseline to 1, 3, and 6 weeks. The mean difference in MTSS was significantly more in bilastine. Cetirizine showed a significant increase in VAS score for sedation as compared to bilastine. Both the drugs were well tolerated and safe. Adverse events like headache, gastric irritation, dryness of mouth, and sedation were more reported in cetirizine group. Conclusion: Bilastine was more efficacious than cetirizine in patients of CSU and the efficacy was seen earlier at 1 week, which was not seen in the cetirizine group.

Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.

Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders. Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed. Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation. Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.

Analysis of clinical trial agreement and insurance policy submitted to the ethics committee of a tertiary care teaching institute in central India.

Purpose: Very few studies conducted in India have analyzed insurance policies and clinical trial agreement (CTA) submitted to ethics committee (EC). This study was conducted to review and find out deficiencies in it. Materials and Methods: This was a retrospective observational study. All the protocols for regulatory clinical trials and academic research sponsored by the Indian Council of Medical Research or other funding agency were included. Insurance documents and CTA submitted with the study protocols were analyzed. Results: A total of seventy CTA and insurance policies were analyzed. CTA mentioned that parties involved in 60 (86%) forms, scope of the agreement in 15 (21%) forms, responsibilities of the party in 68 (97%) forms, and payment details in 58 (83%) forms. Nearly 88.5% of the insurance policies mentioned whether the policy covers the participants for injury due to all clauses and 91% of the policies mentioned the validity period of insurance. Conclusion: It was found that both the documents contained almost all the required elements. This was probably because this institutional EC insisted on and thoroughly reviewed the documents to ensure that adequate compensation of research-related injuries has been provided for and this fact is informed to the trial subject. As very few studies are available in the literature, we could not compare majority of the findings of this study with others.