Yarmouk University (Jordan) Study: ICH/GCP Training Could Benefit Clinical Investigators

Mar 7, 2020 | Ethical, Informed Consent, Jordan, Middle East, Yarmouk University

Yarmouk University (Jordan) Study: ICH/GCP Training Could Benefit Clinical Investigators

Researchers out of Jordan, led by Yarmouk University investigators, sought to identify how well genetic research in this Middle Eastern nation is adhering to ICH/GCP required Informed Consent processes. They concluded that based on the results of this study, Jordanian clinical investigators need additional research ethical training to ensure higher adherence levels.

The Study

The researchers carefully reviewed research studies associated with master theses and grant proposals at two major universities in Jordan. The team studied a total of 44 Informed Consent Forms (ICF) and analyzed them according to the good clinical practice criteria proposed by ICH/GCP. The research team scored for the presence or absence of ICF main items and categories, reported Dovepress.

Results

The research reveals inadequate information present in the examined ICFs. For example, they summarized that the highest information score was 17 out of 20 and the lowest one out of 20. They noted that in a majority of ICFs, critical elements were absent—such as a statement about voluntary participation, the confidentiality of data, compensation to study participants, risk/benefits of the study, and researcher’s contact information. The team concludes that it would appear, at least in an academic context, that an ICH/GCP ethics in research training program could be in order to bolster and improve research in that country.

Clinical Trials in Jordan

With about 10.2 million population, TrialSite News estimates about 76 active clinical trials in the country based on a review of public data. This ration (trials to population) is low compared to many other places. Actual industry trials equal 31 nationwide.

Traditionally, the Middle East and North Africa (MENA) region attracted little attention in the world of clinical research due to 1) political instability, 2) socio-cultural barriers, and 3) lack of procedural and regulatory transparency. MENA countries have done much collectively to improve this and attract more research to the region—hence the region’s share of patients and clinical investigational sites is steadily rising. Jordan was the very first nation, according to one study, to enact clinical regulations in 2001, offering the world a signal that Jordan was in business to do clinical research.

Although the majority of trials in Jordan have been for bioavailability/bioequivalence studies, the number of Phase I-IV studies continue to grow, mostly focusing on cardiovascular diseases, cancer, neuropsychiatric conditions, and diabetes.

Lead Research/Investigators

Alkaraki K Almuthanna, Yarmouk University

Omar F Khabour, Jordan University of Science and Technology

Karem H Alzoubi, Jordan University of Science and Technology

Lina MK Al-Ebbini, Yarmouk University

Zaid Altaany, Yarmouk University

Call to Action: These researchers are to be commended for this study. For those interested in expanding their Middle East research activities, this Jordanian group would be a good one to network with.

Source: Dovepress

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