Productivity of Clinical Trials Conducted in the Gulf Cooperative Council Region

Al-Hajri, Abdullah; Al-Khabori, Murtadha; Rasool, Wasif

doi:10.18295/squmj.11.2021.144

Cited by 3 publications

(3 citation statements)

References 14 publications

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“…Less than 0.1% of the global clinical trials have been reported from the Middle East region [ 5 ]. Historically, clinical research productivity among the Gulf Cooperation Countries in the Middle East, except for Saudi Arabia, has been exceedingly low [ 23 , 24 ]. The paucity of structured information related to clinical research models and inadequate sustainability, two key implementation outcomes, have contributed to the low research productivity in the other Gulf Cooperation Countries [ 5 , 7 ].…”

Section: Discussionmentioning

confidence: 99%

The Development of a Clinical Research Model Complementing Medical Residency and the Assessment of Research Productivity

Nair,

Al-Dahmani

2023

Cureus

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Background and objective: Despite modern healthcare infrastructure, there is a paucity of information about the clinical research framework supporting healthcare in the United Arab Emirates (UAE). Therefore, this study aimed to assess research performance productivity, and the clinical research framework, complementing medical residency, at the nation’s hub for clinical research. Methods: A cross-sectional retrospective review of records from the research database of the institution was conducted to assess productivity, and framework development, and data analyzed. Results: The migration of global healthcare providers, and the pharmaceutical industry offices, the adoption of the International Conference on Harmonization (ICH) guidelines, and electronic medical records established a research culture. Following the development of the governance framework, a total of 1,328 research projects were submitted to the ethics committee until 2023. Approximately 63% of the total studies were of minimal risk, followed by industry-sponsored clinical trials (4.9%, 58/1,163), and prospective interventional studies (3.5%, 39/1,163). Almost half (48.3%, 28/58) of the total industry-sponsored clinical trials were phase II and phase III. The number of peer-reviewed indexed publications, a measure of research productivity, indicated that the periods between 2011 and 2015, 2016 and 2020, and 2021 and 2023 witnessed a 3.8-, 9.3-, and 7.9-fold increase compared to the baseline period (1995-2005). The implementation of the Focus on International Research Strategy, Teaching, Evaluation, and Mentoring (FIRSTEM) strategy, to accommodate mandatory research activity requirements for residents by the physician licensing boards, observed substantial increases in output. The number of international peer-reviewed indexed publications/resident projects doubled from 10.8% (2010-2015) to 24% (2016-2020) and reached 40.1% in 2023. Conclusion: This is the first research governance model established in the UAE, a country with an increasing prevalence of diabetes, and cardiovascular and genetic diseases. The model indicates that the medical trainees differentiate the best research evidence in making decisions about the clinical care of patients. The study outcomes may potentially be useful for other countries in developing a clinical research framework.

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Section: Discussionmentioning

confidence: 99%

The Development of a Clinical Research Model Complementing Medical Residency and the Assessment of Research Productivity

Nair,

Al-Dahmani

2023

Cureus

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“…34 A 19 years review showed that gulf countries contributed to only 0.35% of the worldwide clinical trials, where Saudi Arabia had the highest proportion. 35 Among all the registered trials, no trial was done on xenotransplantation. Despite the high number of the population in this region, numerous challenges including the insufficient funds by national authorities and appropriate training, resulted in low number of clinical trials conducted in the MENA region compared to the other countries.…”

Section: Research and Publications Tackling Xenotransplantationmentioning

confidence: 99%

“…Compared to other countries and regions, the research activity in the Arab World is poorly developed 34 . A 19 years review showed that gulf countries contributed to only 0.35% of the worldwide clinical trials, where Saudi Arabia had the highest proportion 35 . Among all the registered trials, no trial was done on xenotransplantation.…”

Section: Research and Publications Tackling Xenotransplantationmentioning

confidence: 99%

Barriers toward xenotransplantation in Arab World

Ghazi,

Saleh,

Abdallah

et al. 2024

Xenotransplantation

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Organ transplant is a crucial therapeutic strategy offering a life‐saving and transformative medical intervention. It provides an opportunity to improve their quality of life and increase their lifespan. The shortage of organs remains a critical global challenge, leading to a prolonged waiting times for organ receivers, which contributes to an increase in morbidity and mortality rates. Hence, xenotransplantation offered a promising solution to the global shortage of organs through the use of animal organs, leading to an increase in donor availability, reducing waiting times, minimizing organ trafficking, improving genetic engineering advancements, and driving scientific innovation. Even though xenotransplantation has many benefits in the clinical setting, it has many barriers that are hindering its achievements and constraining its occurrence. Some barriers to xenotransplant are general, such as the immunological barrier, while others are specific to certain regions due to local causes. The Arab region exhibits disparities in clinical settings compared to the global context, marked by the huge economic crisis and a shortage of trained healthcare professionals. Considering the huge resources and advancements needed in the field of xenotransplantation, this review aims to explore the specific barriers toward xenotransplantation in the Arab countries, highlighting the challenges to overcome these barriers.

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Oncology Early-Phase Clinical Trials in the Middle East and North Africa: A Review of the Current Status, Challenges, Opportunities, and Future Directions

Alotaibi,

Anis,

Alloghbi

et al. 2024

Journal of Immunotherapy and Precision Oncology

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Clinical trials, the empirical discipline of medical experimentation conducted on human subjects, have engendered a paradigm shift in medical research. The need for new clinical studies is paramount in the Middle East and North Africa (MENA) region, with its rising cancer incidence and demand for efficient oncology treatments. This paper comprehensively reviews the challenges, opportunities, and future directions of phase I oncology clinical trials in the MENA region. Early-phase trials are vital in determining drug dosage and assessing toxicity, bridging the gap between preclinical research and clinical practice. Considering the unique landscape of MENA, this review explores regulatory aspects, specific hurdles faced, potential advantages, and areas for improvement in conducting these trials. Various future directions can be pursued to maximize the potential of phase I oncology trials in MENA. While regulatory bodies like the Ministry of Health adhere to the International Conference on Harmonization–Good Clinical Practice guidelines, a unified system meeting high standards would yield better results. Strengthening research infrastructure, establishing research centers, incorporating clinical trial education into the curriculum, and improving access to medical facilities are crucial. Enhancing consumer understanding of research would facilitate increased participation and promote sustainability in trial recruitment. Navigating various funding sources would open the door for more funding opportunities. Collaborations between academia, industry, and regulatory bodies, both international and local, should be fostered to promote knowledge sharing, resource pooling, and harmonization of standards. Such collaborations would contribute to the sustainability of clinical trial activities by leveraging collective expertise, sharing research infrastructure, and distributing the burden of regulatory compliance. By adopting these strategies, the MENA region can advance its capacity to conduct early phases of oncology trials and contribute significantly to the global medical research landscape.

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Productivity of Clinical Trials Conducted in the Gulf Cooperative Council Region

Cited by 3 publications

References 14 publications

The Development of a Clinical Research Model Complementing Medical Residency and the Assessment of Research Productivity

The Development of a Clinical Research Model Complementing Medical Residency and the Assessment of Research Productivity

Barriers toward xenotransplantation in Arab World

Oncology Early-Phase Clinical Trials in the Middle East and North Africa: A Review of the Current Status, Challenges, Opportunities, and Future Directions

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