Article type
Abstract
"Background:
Clinical trials are considered as gold standard in the field of evidence-based medicine. Registration of trials ensures transparency, accountability, and accessibility of clinical trials. It has been observed in various surveys that some issues are associated with the reporting and the quality of clinical trials.
Objectives:
Current status of clinical trial registration in dentistry in India in Clinical Trial Registry of India portal. Identifying solutions for problems in filling out the CTRI form related to research integrity.
Methods:
This study was done by using the search Keyword “Dental” on www.ctri.nic.in to gather the clinical trials registered up to August 2023. A team of four reviewers evaluated the clinical trials registered in the CTRI pertaining to dentistry. All the parameters were filled in a predesigned data extraction sheet in an anonymized way containing 32 such as type of trial, type of study design, source of funding, method followed like blinding, publication status etc. All parameters were reported as frequency and percentages. Differences between the categorical variables were analysed statistically.
Results:
With the statistical analysis of 1084 Data entries, 830 studies are included and 254 studies are excluded. It was observed that 81.5 % of the studies registered are prospective, 73.5 % of trials are part of a PG thesis, 66.4 % are randomized controlled trials, 98.2 % of trials have do not require clearance from Drug Controller General of India, only 4.5 % of trials have been published and citation is updated among others.
Conclusions:
Based on the data obtained, the number of trials registered is less than it should be and those trials registered have not reported the results and updated the publication status. An appeal should be made to extend the requirements related to ethics while submitting the various parameters in clinical trial registry, particularly relating to research integrity.
"
Clinical trials are considered as gold standard in the field of evidence-based medicine. Registration of trials ensures transparency, accountability, and accessibility of clinical trials. It has been observed in various surveys that some issues are associated with the reporting and the quality of clinical trials.
Objectives:
Current status of clinical trial registration in dentistry in India in Clinical Trial Registry of India portal. Identifying solutions for problems in filling out the CTRI form related to research integrity.
Methods:
This study was done by using the search Keyword “Dental” on www.ctri.nic.in to gather the clinical trials registered up to August 2023. A team of four reviewers evaluated the clinical trials registered in the CTRI pertaining to dentistry. All the parameters were filled in a predesigned data extraction sheet in an anonymized way containing 32 such as type of trial, type of study design, source of funding, method followed like blinding, publication status etc. All parameters were reported as frequency and percentages. Differences between the categorical variables were analysed statistically.
Results:
With the statistical analysis of 1084 Data entries, 830 studies are included and 254 studies are excluded. It was observed that 81.5 % of the studies registered are prospective, 73.5 % of trials are part of a PG thesis, 66.4 % are randomized controlled trials, 98.2 % of trials have do not require clearance from Drug Controller General of India, only 4.5 % of trials have been published and citation is updated among others.
Conclusions:
Based on the data obtained, the number of trials registered is less than it should be and those trials registered have not reported the results and updated the publication status. An appeal should be made to extend the requirements related to ethics while submitting the various parameters in clinical trial registry, particularly relating to research integrity.
"