Clinical trials in the Middle East and North Africa (MENA) Region: Grandstanding or Grandeur?

Nair, Satish Chandrasekhar; Ibrahim, Halah; Celentano, David D.

doi:10.1016/j.cct.2013.05.009

Cited by 58 publications

(79 citation statements)

References 17 publications

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“…Trials with sites in non-high-income countries also tend to recruit more subjects when compared to those conducted exclusively in high-income countries, indicating that subjects from non-high-income countries may contribute substantially to trial results. This is consistent with the limited prior work examining potential differences in trial characteristics conducted in high- and non-high-income countries [24–26]. …”

Section: Discussionsupporting

confidence: 90%

Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013

Murthy

Mandl

Bourgeois

2015

Health Res Policy Sys

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BackgroundIndustry-sponsored clinical trials, in the past performed almost exclusively in more developed countries, now often recruit participants globally. However, recruitment from outside high-income countries may not represent the ultimate target population for the intervention. Clinical trial registries provide an opportunity to quantify and examine the type of clinical research performed in various geographic regions. We sought to characterize industry-sponsored randomized controlled trials conducted in high-income countries and to compare these trials to those performed outside high-income countries.MethodsClinical trial data on all industry-funded randomized controlled trials conducted between 2006 and 2014 were obtained from the registry ClinicalTrials.gov. Trials were classified according to their study sites as conducted in high or non-high income countries, and data on trial characteristics were collected.ResultsOf 22,511 relevant trials, a total of 6,085 (27.0 %) trials included study sites outside a high-income country, and 2,045 (9.1 %) were conducted exclusively outside high-income countries. Of country groups, Central Europe had the greatest number of trials (3,127), followed by Eastern Europe (2,075). The percentage of trials with study sites outside high-income countries remained relatively constant over the study period. Studies with sites outside high-income countries tended to recruit more participants (median enrolled participants 265 vs. 71, P <0.001), to be longer (median study duration 20 vs. 13 months, P <0.05), and to study more advanced phase interventions (Phase 3 or 4 trial 58 % vs. 33 %, P <0.001).ConclusionsMore than a quarter of industry-sponsored trials include participants from outside high-income countries and this rate remained stable over the 7-year study period. Trials conducted outside high-income countries tend to be larger, have a longer duration, and study later phase interventions compared to studies performed exclusively in high-income countries.Electronic supplementary materialThe online version of this article (doi:10.1186/s12961-015-0019-6) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 90%

Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013

Murthy

Mandl

Bourgeois

2015

Health Res Policy Sys

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“…Nair et al observed that only 0.5% of all clinical trials conducted worldwide included participants from the Middle East and North Africa. 13 This finding is discouraging and may reflect various barriers to clinical trial participation in the region, such as poor infrastructure, low expertise, lack of funding and patient reluctance. Nevertheless, the majority of participants in the present study believed that clinical trials were beneficial to society; this is consistent with findings from Balasubramanian et al 's study, in 12 The reason for this difference in results is unclear, especially as the level of knowledge of clinical trials in both cohorts was poor.…”

Section: Discussionmentioning

confidence: 99%

Knowledge and Attitudes Towards Clinical Trial Participation in Oman: A cross-sectional study

Al-Lawati

Al-Baimani

Al-Zadjali

et al. 2018

Sultan Qaboos Univ Med J

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Objectives: Clinical trials are prospective studies on human subjects designed to answer various clinical questions. However, only a limited number of clinical trials have been conducted in Oman. This study aimed to assess the knowledge and attitudes of Omani patients and their relatives towards participating in clinical trials. Methods: This cross-sectional study was conducted between October 2015 and March 2016 among 174 patients and relatives attending the Haematology and Oncology Outpatient Clinics and Day Care Unit of the Sultan Qaboos University Hospital, Muscat, Oman. A self-administered questionnaire was designed to elicit participants' knowledge of and attitudes towards participation in clinical trials. Results: A total of 100 patients and relatives agreed to take part in the study (response rate: 57.5%). The male-to-female ratio was 1:1.2. Only 31.3% of the studied population knew what clinical trials were and only 6.5% had themselves previously participated in a clinical trial. The majority agreed or strongly agreed that they would participate in clinical trials related to their own condition (59.2%). Overall, 89.7% expected to be informed about potential clinical trials by their treating physicians. Conclusion: Omanis had a low level of knowledge of clinical trials and a very low rate of previous participation in such trials, despite a moderate level of interest. Patients should therefore be educated and informed of ongoing clinical trials in order to improve participation rates for clinical trials conducted in Oman. Keywords

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“…The MENA region includes 22 countries and territories and accounts for 385 million people representing 6% of the world’s population (9). The MENA region has an annual population growth rate of 1.8% compared to a 1.2% average global population growth rate (United Nations, Department of Economic and Social Affairs-Population Division, Population Estimates and Projections Section-World Population Prospects, 2015 Revision).…”

Section: Mena Definition Population and Ethnicitymentioning

confidence: 99%

Primary Immunodeficiency Diseases in Highly Consanguineous Populations from Middle East and North Africa: Epidemiology, Diagnosis, and Care

Al‐Mousa

Al‐Saud

2017

Front. Immunol.

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Middle East and North Africa region (MENA)1 populations are of different ethnic origins. Consanguineous marriages are common practice with an overall incidence ranging between 20 and 50%. Primary immunodeficiency diseases (PIDs) are a group of heterogeneous genetic disorders caused by defects in the immune system that predisposes patients to recurrent infections, autoimmune diseases, and malignancies. PIDs are more common in areas with high rates of consanguineous marriage since most have an autosomal recessive mode of inheritance. Studies of PIDs in the region had contributed into the discovery and the understanding of several novel immunodeficiency disorders. Few MENA countries have established national registries that helped in estimating the prevalence and defining common PID phenotypes. Available reports from those registries suggest a predominance of combined immunodeficiency disorders in comparison to antibody deficiencies seen in other populations. Access to a comprehensive clinical immunology management services is limited in most MENA countries. Few countries had established advanced clinical immunology service, capable to provide extensive genetic testing and stem cell transplantation for various immunodeficiency disorders. Newborn screening for PIDs is an essential need in this population considering the high incidence of illness and can be implemented and incorporated into existing newborn screening programs in some MENA countries. Increased awareness, subspecialty training in clinical immunology, and establishing collaborating research centers are necessary to improve patient care. In this review, we highlight some of the available epidemiological data, challenges in establishing diagnosis, and available therapy for PID patients in the region.

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Clinical trials in the Middle East and North Africa (MENA) Region: Grandstanding or Grandeur?

Cited by 58 publications

References 17 publications

Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013

Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013

Knowledge and Attitudes Towards Clinical Trial Participation in Oman: A cross-sectional study

Primary Immunodeficiency Diseases in Highly Consanguineous Populations from Middle East and North Africa: Epidemiology, Diagnosis, and Care

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