EL Hassan Centre

for Neglected Tropical Diseases Clinical Trials Research

The El Hassan Centre for Neglected Tropical Diseases Clinical Trials Research is a specialised facility focused on conducting clinical trials for neglected tropical diseases (NTDs). Founded in 2016, the center is located at Soba University Hospital, University of Khartoum. It was established through a collaborative initiative involving the Drugs for Neglected Diseases Initiative (DNDi) in Geneva, the Ministry of Higher Education and Scientific Research in Sudan, and the Mycetoma Research Centre at the University of Khartoum.

Prof. Ahmed Mohamed EL Hassan

Professor EL Hassan held the position of Emeritus Professor of Pathology at the Institute of Endemic Diseases, University of Khartoum, Sudan. He has had a distinguished career, serving as the Head of the Department of Pathology, at the University of Khartoum, followed by roles as the Dean of the Faculty of Medicine and the Deputy Vice-Chancellor at the University of Khartoum.

In addition to his academic roles, he played a pivotal role as the founding Minister of the Ministry of Higher Education and Scientific Research in Sudan. He also served as the Professor and Chairman of the Department of Pathology and Director of Publications and Translations at the College of Medicine and Medical Sciences at King Faisal University in Dammam, Saudi Arabia.

Prof. EL Hassan has made significant contributions internationally, being the founding President of the Sudanese National Academy of Sciences. He has held visiting professorships at esteemed institutions such as the University of London, University of Copenhagen, and University of the 6th of October.

His extensive scholarly work is reflected in over 300 publications. Professor EL Hassan has been recognised with numerous awards, including the Kitchener Memorial Prize from the University of Khartoum, the Shousha Prize from the World Health Organization, the Donald Mackey Prize from the Royal Society of Tropical Medicine and Hygiene, and the El Zubair Prize for Medicine from the Government of Sudan. He has also been honoured with the EL Neelain Order by the Government of Sudan.

Overview

Conducting clinical experimental research is essential to establish the safety and efficacy of specific health and medical products and practices. The current understanding of the safety and effectiveness of various products and treatments largely stems from randomised controlled clinical trials designed to address crucial scientific and healthcare inquiries. These trials constitute the cornerstone of “evidence-based medicine,” with their reliability hinging on adherence to principles and standards collectively known as “Good Clinical Research Practice” (GCP).

Neglected Tropical Diseases (NTDs) are infectious ailments that inflict immense suffering due to their disfiguring, debilitating, and sometimes fatal consequences. Termed “neglected” because they have been eradicated in more developed regions but persist in the poorest, most marginalised communities and conflict areas. NTDs bring about social stigma, adding to the physical and emotional distress they cause. Beyond the individual impact, these debilitating diseases hinder employment, keep children out of school, and impede the prosperity of families and communities.

Most commonly affecting the poorest communities in remote regions, NTDs impact individuals with low socioeconomic status, limited visibility, and a diminished political and social voice, leading to neglect. The diseases are associated with social stigma, especially among females and children, prompting individuals to conceal their condition for an extended period. When compelled to seek medical care, the diseases are often at an advanced stage.

Vision & Objectives

Vision:

To attain optimal advancements in clinical research related to Neglected Tropical Diseases, aiming for the highest standards of patient care on a global scale.

Objectives:

The objectives of the Center include the following activities:

Exceptional management of patients.
Conducting high-quality clinical trial research.
Providing excellent training for medical and health staff.
Advocating for awareness of Neglected Tropical Diseases (NTDs).
Equipping peripherals with trained medical and paramedical staff.
Organising and hosting scientific meetings.
Regularly publishing informative materials.
Collaborating with and actively participating in the scientific activities of relevant global bodies.

Management:

The overall execution of the Center’s mission falls under the purview of the Management, which is responsible for planning project-related activities, ensuring compliance with timelines and maintaining high-quality standards. The Management is dedicated to delivering services that surpass client expectations and guarantees that the entire workflow adheres to both international regulatory requirements and the internal Standard Operating Procedures (SOPs) of the Center. Oversight of the collaborative efforts of various units, the establishment of communication lines and interfaces, and leadership all fall under the responsibilities of the Management. The General Manager heads the Management, serving as the point of reporting for all units within the Center.

Centre Units

The Center comprises several units, which encompass:

Clinical Unit

This includes 24 beds distributed across four cubicles, with a central nurse station strategically placed for convenient monitoring of study participants. The unit is equipped with a central physiological monitoring system that connects to bed-head physiological monitors and a telemetry system. Additionally, a surveillance camera system is in place to support safety monitoring. A dedicated resuscitation room is available for medical emergencies, providing 24-hour support from the SUH central resuscitation team and intensive care unit (ICU). The unit also features a Surgical Complex Unit comprising an operating theatre, recovery area, sterilisation unit, and changing rooms. An outpatient clinic is available for regular patient consultations and follow-ups, managed by MRC research assistants. The Center is furnished with a state-of-the-art Ultrasound machine, offering scanning, recording, and image storage capabilities, thereby enhancing the early detection and management of mycetoma cases.

Biological Specimen Management Facility

There are two specifically designated rooms for processing biological specimens, each equipped with refrigerated centrifuges and a biosafety cabinet, facilitating the concurrent handling of two studies. Additionally, there is a dedicated room for storing biological specimens containing freezers at -20 °C and -70°C.

Study Drug Management Facility

The Center features a specialised room for drug storage, equipped with refrigerators set at 4°C and -20 °C (for refrigerated drugs) and temperature- and humidity-controlled cabinets (for drugs requiring ambient temperature). There is also a designated drug processing room for the controlled handling of study drugs, featuring a biosafety cabinet for drug reconstitution and electronic balances for precise dose adjustments. The facility is equipped with emergency electricity backup, an uninterrupted power supply, and a 24-hour monitoring and alarm system for all refrigerators and freezers. Regular maintenance and calibration for major equipment systems are conducted with comprehensive documentation.

The Quality Assurance and Archive Unit

The Quality Assurance Unit (QAU) operates as a standalone unit accountable to the general manager at the central office. Its primary objective is to consistently enhance the Quality Management System. By conducting routine monitoring, the Unit verifies compliance with GLP, GCP guidelines, and internal SOPs, ensuring the fulfillment of quality requirements.

Quality management involves the following major activities:

Assuring quality program (planning, conducting and reporting of inspections).
Preparing annual training schemes training of personnel.
Administering and archiving of SOPs.
Evaluation of the requirements of new guidelines.
Assisting sponsor audits.
Auditing (system audit, study audit).
Assisting authority inspections and answering their queries.
Suggesting corrective actions, monitoring and documentation of implementation of corrective actions, and undertaking risk management.

The major tasks encompassed by the quality assurance program include:

Good laboratory practices (GLP)

Project independent inspections according to the annual master plan.
Project-dependent inspections of analytical protocols, analytical project performances and analytical reports.
Preparing inspection reports and follow-up of findings.
Preparing QAU statement.

Good clinical practices (GCP)

Conducting system audits in clinic units.
Performing study audits including study protocol, ICF, CRF and TMF.
Undertaking study audits during clinical performance.
Preparing audit reports and follow-up of findings; and
Preparing QAU-statement.

The Quality Assurance (QA) team ensures the efficient and high-quality execution of projects. Ongoing training in system improvement is provided to all personnel engaged in the study, with additional training available to clients upon request. QA staff are mandated to stay abreast of current knowledge in the field and are periodically required to attend continuing education programs, as well as participate in QA workshops and conferences as needed.

The Data Centre

The Data Centre holds the responsibility for comprehensive data management, encompassing tasks such as data entry, processing, statistical analysis, and presenting data in the form of tables and figures. Additionally, it oversees data storage and retrieval. The Center employs a secure storage system, ensuring the accessibility and identification of all archived study-related documents and stored product samples. Stringent archiving Standard Operating Procedures (SOPs) are in place, with controlled and restricted access limited to authorised personnel to maintain security.

Storage areas are meticulously maintained to prevent dampness, which could lead to premature deterioration. Records are systematically stored on the internet cloud system and other media, undergoing regular “back-up” intervals. These backups are securely stored in protected locations to safeguard against loss or damage of active data.

The duration for which study documents, including raw data and product samples in the archive, are retained is defined in compliance with local regulations or international recommendations, as appropriate.

The Administration Unit

The Administration Unit oversees the comprehensive administration and housekeeping of the organisation. It comprises various sub-units, including Human Resources, Finance, Public Relations, Marketing, and Business Management.

The Administration:

Centre Director
Centre Coordinator
Clinical Team Lead
Laboratory Team Lead
Supportive Staff

Centre Teams

The center comprises various teams dedicated to carrying out specific functions and tasks. These teams encompass:

The Clinical and Diagnostics
The Monitoring
The Data Management
The Quality Assurance
Public Engagement
Logistics and Support

The Clinical and Diagnostics Team

Ahmed Hassan Fahal, Professor of Surgery, the Mycetoma Research Centre, University of Khartoum. Khartoum, Sudan.
Ahmed Modiuwi Musa, Professor of Immunology, The Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan
Dr Sahar Mubarak Bakhiet, Assistant Professor Molecular Biology, The Institute of Endemic Diseases, University of Khartoum
Mr Elsamani Wad Allah, Consultant Surgeon, the Mycetoma Research Centre, University of Khartoum. Khartoum, Sudan.
Miss Bouthina Mamoun, Consultant Surgeon, the Mycetoma Research Centre, University of Khartoum. Khartoum, Sudan.
Dr EL Rayah Mustafa, Senior Radiologist, Soba University Hospital, University of Khartoum, Khartoum
Dr Mustafa EL Nour, Assistant Professor of Radiology, Faculty of Medicine, University of Khartoum
Dr Badreldin Mirgani Yousif, Consultant Histopathologist, Soba University Hospital.
Dr Eiman Siddig, Research Assistant, The Mycetoma Research Centre, University of Khartoum
Dr Rayan Ali, Research Assistant, The Mycetoma Research Centre, University of Khartoum
MRS Rahab Ahmed, Senior Laboratory Technologist
Mrs Lubna EL Nour, Laboratory Technologist
Miss Omnia Babikir, Laboratory Tecnologist
Miss Naema Ahmed EL Shabli, Laboratory Technologist
Ten Senior Surgical Registrars
Three Medical Imaging Registrars
One Anaesthetic Registrar
Four Surgical Theatre Attendants
Four Anesthetic Assistants
Medical Imaging Nurse
Two Nurses
Medical Information Officer

The Data Management team

The Advocacy and Awareness Team:

Mrs Hanan Faisal. Health Promotion Officer
Mrs Ensaf Tawer, Health Promotion Officer
Mr Khalid Hamid, Conceptual Visual Artist

Community leaders and activists

Logistics and Support Team:

Mr Ameer Faroug, Logistics Officer, The Mycetoma Research Centre, University of Khartoum.
Mr A. Razig Osman, Senior Nurse, The Mycetoma Research Centre, University of Khartoum
Porters and drivers

Public Engagement Team

Donors And Supporters

The center is fortunate to have numerous donors, supporters, and friends, and among them, the following individuals or entities have made significant contributions:

Ministry of Higher Education and Scientific Research
University of Khartoum
DNDi
Soba University Hospital
The Sudan National Medical Insurance Fund
The Mycetoma Research Centre

El Hassan Presentation

Ethic of research involving human subjects in Sudan.pptx
In memory of Dr Mohamed Hamad Satti.docx
Kala-azar in Sudan.ppt
leishmaniasis Directions for research.pptx
Leprosy for Medical students.pptx

Mycetoma Pathology. pptx