Productivity of Clinical Trials Conducted at the Gulf Cooperative Council

Objectives: Clinical trial productivity has not been investigated in the Gulf Cooperation Council (GCC) region, including Oman, Saudi Arabia, United Arab Emirates (UAE), Qatar, Bahrain, and Kuwait. We aim to assess the productivity of clinical trials conducted in the GCC region. Specifically, we aim to estimate the number of clinical trials conducted and estimate the proportion of clinical trials conducted in the GCC countries published in peer-reviewed journals. Methods: The clinical trials registry of the U.S. National Library of Medicine (NLM) was searched for clinical trials conducted from January 2000 to October 2019. The productivity was assessed by the publication status of the trials in the registry and through the search in Medline indexed journals. Results: A total of 682 trials were found from the GCC region, with an overall trend of 4.1 trials each year. However, the clinical trial productivity from our area contributes to only 0.37% of the trials globally. When comparing the raw data, Saudi Arabia shows the highest proportion by contributing 66.6% of the clinical trials from the region (p < 0.001). Oman contributed 3.5 %. After normalization to population, Qatar shows to be the highest with 42.78 trials per million. A total of 238 trials were conducted before 2016, of which 46.6% were published. Conclusion: Saudi Arabia is the leading country in clinical trial productivity in the GCC region. Countries should utilize the triple helix model to a partnership with industry and improve their contribution to science. Keywords: Productivity; Clinical Trials; Publication; Oman; Gulf Cooperative Council.

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Effects of an Art-Based Curriculum on Clinical Trials Attitudes and Breast Cancer Prevention Knowledge

Health Education & Behavior ◽

10.1177/1090198105277856 ◽

2006 ◽

Vol 33 (5) ◽

pp. 664-676 ◽

Cited By ~ 1

Author(s):

Patricia M. Herman ◽

Linda K. Larkey

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Clinical Trials ◽

Education Program ◽

Cancer Education ◽

Controlled Study ◽

Breast Health ◽

Breast Cancer Education ◽

The Difference ◽

The U.S

Although Latinos now comprise the largest minority in the U.S. population, they continue to be seriously underrepresented in clinical trials. A nonrandomized controlled study of an innovative community-developed clinical trial and breast cancer education program targeting Latinas tested whether use of an art-based curriculum could increase willingness to enroll in six clinical trial scenarios and increase breast health and clinical trial knowledge. The art-based curriculum resulted in a larger increase in stated willingness to enroll across all clinical trial scenarios, and the difference was statistically significant ( p < .05) in three. Breast health and clinical trials knowledge increased similarly and significantly for both groups. The results of this study show promise for the use of a community-developed art-based curriculum in the Latina population to increase willingness to enroll in clinical trials.

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Cobalt-chromium versus titanium alloy rods for correction of adolescent idiopathic scoliosis based on 1-year follow-up: a multicenter randomized controlled clinical trial

Journal of Neurosurgery Spine ◽

10.3171/2020.9.spine201486 ◽

2021 ◽

pp. 1-10

Author(s):

Daisuke Sakai ◽

Masato Tanaka ◽

Jun Takahashi ◽

Yuki Taniguchi ◽

Jordy Schol ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Thoracic Kyphosis ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Cobalt Chromium ◽

Rib Hump ◽

Randomized Controlled ◽

Clinical Trials Registry

OBJECTIVE For instrumented correction surgery for adolescent idiopathic scoliosis (AIS), surgeons are increasingly switching from titanium (Ti) alloy rods to stiffer cobalt-chromium (CoCr) rods. The authors conducted the first multicenter randomized controlled clinical trial to investigate whether these materials affect the outcomes in terms of spine correction and quality of life (QOL). This trial was registered at UMIN Clinical Trials Registry on September 3, 2012, under the identifier UMIN000008838 (level of evidence 1). METHODS Female AIS patients (Lenke types 1–3, patient age 10–19 years) were recruited at 5 Japanese institutions and randomized into two cohorts: 6.0-mm-diameter Ti rods were placed in one group, and 6.0-mm-diameter CoCr rods were placed in the other. Patients were followed up at 2 weeks and 3, 6, and 12 months with radiographic examination to quantify the sagittal and coronal correction (Cobb angle, thoracic kyphosis, rib hump, and apical vertebral rotation). Patients completed questionnaires (Scoliosis Research Society–22r, 12-Item Short-Form Health Survey, and Scoliosis Japanese Questionnaire–27) at 6 and 12 months to assess QOL. RESULTS A total of 69 AIS patients were randomized to the demographically similar Ti (n = 37) or CoCr (n = 32) cohort. Four adverse events were recorded, two in each cohort, but these were not related to the rod material. At the final follow-up, both Ti and CoCr cohorts showed significant improvement in spinal correction, including the Cobb angle, thoracic kyphosis, and rib hump size. The correction rates were 68.4% and 67.1% for the Ti and CoCr cohorts, respectively. No parameters differed significantly between the cohorts at any time. Survey data showed improved but similar outcomes in both cohorts. CONCLUSIONS Both treatments (Ti and CoCr) produced similar results and were efficient in engendering clinically significant spine corrections. Clinical trial registration no.: UMIN000008838 (UMIN Clinical Trials Registry)

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Prospects for the Gulf states to end-2017

Emerald Expert Briefings ◽

10.1108/oxan-db221288 ◽

2017 ◽

Keyword(s):

Saudi Arabia ◽

United Arab Emirates ◽

Gulf Cooperation Council ◽

Content Type ◽

Gcc Countries ◽

Oil Revenue ◽

Gulf States

Subject Prospects for the Gulf states to end-2017. Significance Gulf Cooperation Council (GCC) countries agree on the need to check Iran’s regional aspirations, but differ radically on how to achieve this goal -- pushing Saudi Arabia, Bahrain and the United Arab Emirates (UAE) to open confrontation with Qatar and leaving Kuwait and Oman caught uncomfortably in the middle. At the same time, they face the major challenge of adjusting their economies to long-term expectations of lower oil revenue.

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The impact of newly approved drugs on clinical and operational strategies for multiple myeloma clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e19511 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e19511-e19511

Author(s):

Bhavani Krishnan ◽

Bernadette Collins ◽

Michael Jeffrey Cho ◽

Tanya Partridge ◽

Durga Vighnay ◽

...

Keyword(s):

Clinical Trial ◽

Multiple Myeloma ◽

Clinical Trials ◽

Real World ◽

Operational Strategies ◽

Clinical Trial Enrollment ◽

Near Term ◽

Approved Drugs ◽

The Impact ◽

The U.S

e19511 Background: The global burden of multiple myeloma (MM) has increased steadily in last 3 decades. The IARC reports there were ~160,000 new cases worldwide in 2018. There has been an increase in the development and approval of more effective targeted therapy options (new immunomodulatory agents, proteasome inhibitors, and monoclonal antibodies); this, coupled with high adoption of these therapies presents a major challenge in enrollment of current ongoing clinical trials. We assessed the impact of near-term regulatory approvals on clinical trial enrollment. Methods: Public domain clinical trial enrollment data from MM studies (Phase I, I/II, II) closed/completed between 2011-2018 were used to determine enrollment trends pre and post 2014. We leveraged real-world medical claims data to project/model adoption of recently approved drugs in the U.S.; additionally, drug sales volume data was used to evaluate ex-US national adoption trends. The utilization rates of 5 recently approved drugs by regimen and line of treatment was determined. Results: In the U.S., there is a 13% increase in median enrollment duration with a corresponding 25% decrease in median p/s/m enrollment in MM studies, irrespective of phase, where enrollment was completed between 2015 -2018 compared to 2011-2014. We hypothesize that one of the factors for this increase in enrollment timeline is the approval and adoption of newly approved therapies post 2014. Two of the five recently approved drugs show a steady increase in the number of patients treated over 2016, 2017 and 2018, while one of the drugs plateaus over the same period. Outside of the U.S., our analysis confirms the existence of gaps in time to approval /adoption of recently approved drugs; for example, we observe a two-year delay in approval/adoption for one of the drugs in France compared to the other countries in Western Europe. Conclusions: There are over 10 investigational MM drugs currently in development which are anticipated to be granted approval between 2019-2021. Factoring the real-world adoption of near-term drug approval into global clinical and operational strategies offers insights into mitigating potential future enrollment challenges.

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Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

BMJ Open ◽

10.1136/bmjopen-2017-019983 ◽

2018 ◽

Vol 8 (3) ◽

pp. e019983 ◽

Cited By ~ 15

Author(s):

Kylie Elizabeth Hunter ◽

Anna Lene Seidler ◽

Lisa M Askie

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

New Zealand ◽

Random Sample ◽

Descriptive Analysis ◽

Perceived Usefulness ◽

Trial Registration ◽

Industry Type ◽

Complete Dataset ◽

Clinical Trials Registry

ObjectivesTo analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration.DesignPart 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey.ParticipantsPart 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015.Main outcome measuresPart 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance.ResultsPart 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration.ConclusionsDespite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance.

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Cross-Sectional Analysis of Data from the U.S. Clinical Trials Database Reveals Poor Translational Clinical Trial Effort for Traumatic Brain Injury, Compared with Stroke

PLoS ONE ◽

10.1371/journal.pone.0084336 ◽

2014 ◽

Vol 9 (1) ◽

pp. e84336 ◽

Cited By ~ 9

Author(s):

Lucia M. Li ◽

David K. Menon ◽

Tobias Janowitz

Keyword(s):

Clinical Trial ◽

Traumatic Brain Injury ◽

Clinical Trials ◽

Brain Injury ◽

Cross Sectional ◽

Cross Sectional Analysis ◽

Sectional Analysis ◽

The U.S

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Diversification of Domestic Politics of the GCC Member States After the Second Gulf War

Acta Orientalia Vilnensia ◽

10.15388/aov.2000.18326 ◽

2000 ◽

Vol 1 ◽

Author(s):

Egdūnas Račius

Keyword(s):

Saudi Arabia ◽

United Arab Emirates ◽

Persian Gulf ◽

Domestic Politics ◽

Gulf War ◽

Arab Countries ◽

Member States ◽

Gcc Countries ◽

Primary Focus ◽

The Persian Gulf

This paper will concentrate on exploring how the domestic politics of the Gulf Cooperation Council (GCC) countries have been redirected and reshaped as a consequence of the Second Gulf War. Although the war affected directly only Kuwait and Saudi Arabia, it has also been experienced by other GCC member states: Bahrain, next to Saudi Arabia, was a major base of Allied forces, United Arab Emirates had sent its jet–fighters to the operations against Iraqi troops. Therefore, white Kuwait and Saudi Arabia will be the primary focus of the paper, the rest of the Persian Gulf Arab countries will receive partial attention too.

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Father Involvement and Education in the GCC

10.18502/aqf.0160 ◽

2020 ◽

Keyword(s):

Saudi Arabia ◽

Life History ◽

United Arab Emirates ◽

North Africa ◽

Father Involvement ◽

Educational Achievement ◽

Gulf Cooperation Council ◽

Mena Region ◽

Gcc Countries ◽

Education Environment

This policy brief builds on a larger father involvement study that encompasses 10 countries in the Middle East North Africa (MENA) region to identify some of the key challenges of father involvement in the Gulf Cooperation Council (GCC) countries. Using mixed methods with a modified Fatherhood Scale survey and life history interviews, the study found notable differences in father involvement in education across geographic, gender, and generational factors. Overall, fathers in GCC countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) tend to be perceived as more encouraging of their children’s education, especially for their daughters, but are less engaged in the types of quality involvement that are key to educational achievement. Based on the findings of this study, this policy brief highlights some of the key challenges of GCC fathers’ involvement. We conclude by offering recommendations to create and support an education environment in the GCC that values quality father involvement.

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Frequently asked questions regarding treatment of Kawasaki disease

Global Cardiology Science and Practice ◽

10.21542/gcsp.2017.30 ◽

2018 ◽

Vol 2017 (3) ◽

Cited By ~ 1

Author(s):

Jane C Burns

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Kawasaki Disease ◽

Intravenous Immunoglobulin ◽

Common Sense ◽

Personal Experience ◽

Case Series ◽

Evidence Base ◽

Acute Kawasaki Disease ◽

The U.S

[first paragraph of article]The mainstay of therapy for acute Kawasaki disease (KD) is intravenous immunoglobulin (IVIG), which was first described in a case series from Japan and later proven through a nationwide clinical trial in the U.S. published in 1986. Since completion of the initial clinical trials, many questions have arisen regarding the nuances of KD treatment. In the absence of an evidence base, what follows is an attempt to devise rational responses to these questions that draw upon common sense and the personal experience of this author.

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Re-Examining Government Revenues, Government Spending And Economic Growth In GCC Countries

Journal of Applied Business Research (JABR) ◽

10.19030/jabr.v29i3.7777 ◽

2013 ◽

Vol 29 (3) ◽

pp. 737 ◽

Cited By ~ 1

Author(s):

Helmi Hamdi ◽

Rashid Sbia

Keyword(s):

Saudi Arabia ◽

United Arab Emirates ◽

Government Spending ◽

Temporal Relationship ◽

Econometric Model ◽

Gulf Cooperation Council ◽

Government Expenditures ◽

Font Size ◽

Gcc Countries ◽

Toda And Yamamoto

The aim of this paper is to examine the inter-temporal relationship between government revenues and expenditures within a trivariate framework by modeling them together with gross domestic product. Our sample is based on a panel of 6 countries of the Gulf Cooperation Council (GCC) i.e. Saudi Arabia, Kuwait, United Arab Emirates, Qatar, Oman and Bahrain, for the period from 1990 to 2010. We perform an econometric model based on the Toda and Yamamoto procedure. Our empirical results show that government expenditures Granger cause government revenues for Qatar and the United Arab Emirates only, while government revenues Granger cause government expenditures for Saudi Arabia only. We also found a unidirectional causality running from government expenditures to GDP in Bahrain only. Regarding Kuwait, Qatar and Saudi Arabia, GDP Granger cause government revenues while GDP Granger cause government expenditures for Oman and Qatar.

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