Reporting gap of randomized clinical trials registered in Western Mexico, a cross-sectional study
Esmeralda Alcaraz-Sanchez, Universidad de Guadalajara
Tonatiuh Delgado Figueroa, Universidad de Guadalajara
2Universidad de Guadalajara, Mexico
Background: Investigative drug trials and some medical device trials in Mexico are not mandated by the General Health Law to publish their results, and there is currently no legal requirement for any type of trial, posing a challenge for future compliance and enforcement in the country.
Objectives: The objective of this project is to analyze the current proportion of registered projects, their status, whether they belong to the public or private sector, sources of funding, and whether they have published results. Additionally, to analyze the proportion of retrospectively registered clinical trials.
Methods: The clinicaltrials.gov database was reviewed by searching for Mexico, specifically in the Western region. The following fields were extracted: NCT Number, Title, Status, Study Results published, Sponsor/Collaborators, Funded By, Study Type, Start Date, Primary Completion Date, Completion Date, Retrospective registration, Results First Posted, and Locations. Frequencies and proportions were reported.
Results: A total of 1,059 records were analyzed. The reported status in the platform were as follows: 61.5% completed, 15.0% recruiting, 8.8% terminated, 9.0% active not recruiting, 0.8% withdrawn, and 3.5% with unknown status. Only 47.8% of the records had available results. Most of the studies (61.1%) were Phase 3 clinical trials, and 5.3% of the trials involved pediatric populations. Industry funding was reported for 78.7% of the records. Most of the registries (93.3%) were classified as interventional, and 59.4% of the registries were properly registered as prospective studies. Conclusion: In conclusion, this study highlights the concerning lack of legal requirements for drug and medical device trials to publish their results in Mexico. The analysis of the clinicaltrials.gov database reveals a significant proportion of completed trials with no available results, which poses a potential challenge for future compliance and enforcement in the country. Patient, public, and healthcare consumer involvement: This study highlights the crucial role of policy in promoting ethical and responsible conduct in clinical trials, ultimately benefiting patients and public health. As part of the University of Guadalajara initiative, trial participants in Mexico were encouraged to ask sponsors about results, emphasizing the importance of empowering patients and promoting transparency in clinical trial research.