Clinical research in Africa And Middle East: Roadmap for reform and harmonisation of the regulatory framework and sustainable capacity development
Year: 2019
Type: article
Abstract: The Middle East, Mediterranean, Africa (MEMA) region, is composed of 68 countries, totalling a population of over 1.6 billion ie, 20% of the world. It contributes little to the international effort of health knowledge production, hosting only 6% of the worldwide registered trials. Among the many weaknesses of clinical research in MEMA region is the cultural gap and lack of recognition for the need of developing a sustainable clinical research infrastructure. Very few countries have some developed capacity for research. Lack of a robust, international standards, regulatory framework is the second major hurdle. In addition there is uncertain public confidence and poor awareness of the importance and the objectives of clinical research. However, the region has a number of attractive features, such as population's size and large pool of eligible patients, least trial saturated of all regions, diversity in genetic profile, lifestyle, and eating habits, and large medication-naive patient populations.
Source: Journal of Global Health Reports
Authors: Faiez Zannad, Mohamed Sobhy, Wael Almahmeed, Mohamed Balghith, Javed Butler, Souad Dziri, Sahar Ebrahim, Ashraf El Fiky, Ahmed Elshal, Ines Fradi, Ziyad Ghazzal, Chokri Jeribi, Zainab Samad, Maciej Kostrubiec, Manal Milhem, Mossad Morsi, Ali Oto, Hany Ragy, Georges Saade, Rana Malkawi, Azza Saleh, Dina Shokri, Karen Sliwa, Habib Gamra
Institutions: Inserm, Université de Lorraine, Alexandria University, Cleveland Clinic Abu Dhabi, King Saud bin Abdulaziz University for Health Sciences, University of Mississippi, IQVIA (United Kingdom), IQVIA (United States), Emmes (United States), University of Monastir, American University of Beirut Medical Center, American University of Beirut, Aga Khan University, Duke University, European Medicines Agency, Medical University of Warsaw, Memorial Ankara Hospital, National Heart Institute, Lebanese University, Ministry of Health and Population, University of Cape Town, Hospital Fatuma Bourguiba Monastir
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $808
OpenAlex ID: W3012325703