Abstract
The clinical trial is an important type of research design in the spectrum of translational research. The extent to which clinical trials are conducted is a reflection of the level of advancement that exists within a healthcare system. This study aims at describing the clinical trial activity within the Kingdom of Saudi Arabia since 2000 through reviewing those trials that have been registered with clinicaltrials.gov in that time period. Since February 2000, 405 trials have been registered. These trials fall into one of 22 different ICD-10 codes, and with the top four being neoplasms (92), diseases of the circulatory system (57), endocrine, nutritional and metabolic diseases (46), and diseases of the respiratory system (25). About half (200) were classified as trials with both safety and efficacy endpoints. 52% were phase IV and 28% were phase III. About 64% were randomized, and with about equal numbers of those coming from industry (86) and university sponsors (85), and smaller numbers coming from hospitals (51) and other sponsors. A total of 24 phase III university- or hospital-sponsored trials have been registered during the 15-year time period. With a population approaching 30 million and very large annual healthcare expenses, it would appear that the level of clinical trial activity within the Kingdom during the past 15 years has been rather paltry. The emphasis has been on post-marketing phase IV trials. The academic setting (i.e. universities and hospitals) has seen a new trial registered every 11 months on average.
Highlights
The concept of registering clinical trials was first proposed by Professor Robert Simes in 1986 [1]
This study aims at describing the clinical trial activity within the Kingdom of Saudi Arabia (KSA) since 2000 through reviewing those trials that have been registered with ClinicalTrials.gov in that time period
Since the inception of ClinicalTrials.gov, 405 trials from Saudi Arabia have been registered with the registry
Summary
The concept of registering clinical trials was first proposed by Professor Robert Simes in 1986 [1]. ClinicalTrials.gov is recognized as the oldest and largest database for the registration of clinical trials and is managed by the National Library of Medicine at the National Institutes of Health (NIH) in the USA [2]. It started receiving trials in September 1999, and first released its database to the public in February 2000. Dissemination of clinical trials findings is achieved through the publication of the trial's results in peerreviewed scientific journals and the reporting in registries. Registration of clinical trials is imperative to avoid selective reporting and publication bias, as well [8]
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