Résumé
Background: A randomized controlled trial (RCT) is the most valued method for evaluating the drug safety and its efficacy. However, due to incomplete reporting, RCTs may not be a reliable source of information and can lead to false interpretation of outcome. Aim and Objective: The aim of this study was to analyze the completeness in reporting of RCTs published in the Indian medical journals (IMJs) according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and to analyze, if there was a variation in the completeness between registered and unregistered trials. Materials and Methods: This was a cross-sectional study conducted in the Department of Pharmacology, Bangalore Medical College and Research Institute. The clinical trials published by the IMJs between January 2020 and August 2021 were accessed online, and its full text versions published were downloaded. Completeness in reporting of the RCTs with respect to different CONSORT checklist domains was recorded. The impact of trial registration and CONSORT endorsement on the completeness of reporting RCTs according to CONSORT checklist was determined. Descriptive statistics was used to assess and summarize the data. Results: The overall completeness of reporting was 82.4%, better than the previous years. Major areas of reporting deficiencies were in the title and abstract, result, and registration domains. Registered trials reported better than unregistered. Conclusions: Endorsement of CONSORT in the journal had no difference in reporting. Although the quality of reporting RCTs in the IMJs has improved, it remains unsatisfactory. Completeness of trial reporting could be improvised by strict implementation of CONSORT guidelines.
Résumé
Background: Pharmaceutical companies used Drug Promotion Literatures (DPLs) as a major tool to advertise their new products. World Health Organization (WHO) has set some guidelines for promotion of drug literature. Thus, this study aimed to evaluate various DPLs for their accuracy and credibility as per WHO ethical criteria.Methods: This was an observational and cross-sectional study. Total 100 drugs advertisements published in various medical journals were collected from the library of the college. Advertisements were selected based on inclusion and exclusion criteria. The selected advertisements were evaluated based on the WHO ethical criteria for drug promotion.Results: From 100 advertisements, 73 were single drug whereas 27 were fixed drug combinations. Antimicrobials (16%) were the most promoted advertisements. Only 28% of the advertisements carried references to support their claim. Out of which majority (91.78%) were from journal articles. The generic name, brand name, names of active ingredients, manufacturer, distributor and dosage regimen were mentioned in majority of advertisements. Drug interactions (12%), contraindications (22%), precautions (24%) and side effects (22%) were least mentioned in the advertisements.Conclusions: It was observed that none of the advertisement followed all the guidelines laid down by WHO. Pharmaceutical companies should follow ethical regulatory measures to promote their product in various journals. The regulatory authority must ensure the pharmaceutical companies to follow ethical guidelines for publishing various drug promotional literatures.