Fate of registered clinical trials performed in Saudi Arabia

T ClinicalTrials.gov was established by the United States National Institutes of Health in collaboration with the Food and Drug Administration (FDA) in 2000.1 It offers the latest information on clinical randomized controlled trials (RCTs) for a wide range of diseases. One of the original goals of the site was to help patients find trials related to the treatment of their condition.1 Subsequently however, the endorsement of its use had been to enhance the transparency of research, and to decrease the selective reporting of clinical trials.2 The high rate of discontinuation and non-publication of RCTs is topical in the current literature, and has been identified as a common problem to research in general, and within clinical specialties.1-5 Over the last 3 decades, researchers in the Kingdom of Saudi Arabia (KSA) had contributed significantly to the national and international literature. However, up-to-date there have been no reports that examined the magnitude, characteristics, and publication outcome of registered trials that were performed in KSA. The purpose of the study was to investigate the outcomes of KSA-related trials that were registered on ClinicalTrials.com with particular focus on the correlation between the extent of the contribution of the KSA investigators and the study design, completion, and publication rates. This study was carried out at King Khalid National Guard Hospital (KKNGH), Jeddah, KSA. It was a review based on routinely available data with open access; hence, it did not require an ethical approval by KKNGH. An advanced search was carried out in the website ClinicalTrials.gov using the key word “Saudi Arabia”. In view of the daily changes in the database, the search findings on a single day (19th April 2015) were documented and used for analysis. The inclusion criteria were phase 1 to phase 4 clinical trials that were performed completely or partly in KSA, and were registered on the website from January 2000 to December 2012. The latter date was chosen to allow adequate time for trial publication. We included all closed studies that had a status listed at the time of the search as “complete”, “terminated” or “suspended”. Open studies that had a status listed as “unknown”, “recruiting” and “active not recruiting” were excluded. Using each study web page, the trial’s responsible authority was identified. The selected studies were categorized into 3 groups according to the extent of contribution of KSA investigators: studies in which a KSA authority was responsible alone; studies in which a KSA authority was responsible jointly with others; and studies in which KSA researchers provided collaboration only, and were not amongst the responsible authorities. Using each trial web page, the following data was collected for every study: title, National Clinical Trial identification number (NCT-ID), status, sponsor, condition, intervention, design, phase, enrolment, start and completion dates, participating locations, recruitment, publication citation, publishing journal’s impact factor (IF), duration from study completion and publication, and whether KSA investigators were included amongst the authors. To determine whether a clinical trial had been published and to obtain the article’s citation, we searched in the individual’s study website and in PubMed using the study title and its NCT-ID. When a study had more than one listed publication, the relevant abstracts were reviewed, and the article reporting data that resembled the original study description closely was used. Furthermore, the correlations between the extent of contribution of KSA researchers and trials characteristics were assessed by comparing the 3 groups (responsible alone, responsible jointly with others, and collaboration only) using the following parameters: status (completed versus uncompleted), sponsor (industry versus others), condition (cancer versus others), intervention (drug versus others), phase (1-3 versus 4), randomization (yes versus no), blinding (yes versus no), recruitment (national versus international), publication (yes versus no), and KSA researchers inclusion in authorship (yes versus no). In addition, using the median value as a cut-off point we compared the 3 groups in relation to the sample size, participating locations, study duration, publishing journal’s IF, and period from completion to publication. For statistical analysis a chi-squared test was calculated using the Social Science Statistics,6 and significance was determined when p<0.05. Our search identified 138 KSA-linked clinical trials. We excluded 57 open studies as their status at the time of the search was “unknown” in 19, “recruiting” in 19 and “active but not recruiting” in 19. Two more studies Brief Report