Clinical Research

1. Overview: Clinical Research

Clinical Research at ACPN strives to promote and implement evidence-based clinical practice through well-designed research studies, using sound research methodology. This is in line with the mission of Department of Health (DOH) to promote world class research that improves health and quality of life of both citizens and residents, and in keeping with the vision of ACPN to be the leading regional neuroscience institute. This approach enables us to fulfill the vision of ACPN in providing the best evidence-based patient center care. Evidence-based practice helps in improving general quality of life through improved diagnosis and treatment, as well as reducing morbidity and mortality rates. Empirical evidence changes our approach to decision-making in clinical practice, while also giving us validity and credibility as one of the main healthcare providers in the UAE.

2. ACPN Institutional Review Board (IRB)

ACPN has a well-established Institutional Review Board, in compliance with the guidelines set by the International Council for Harmonization for Good Clinical Practice (ICH-GCP) and authorized by Department of Health (DOH) to run clinical trials and scientific research studies. The board is made up of both internal and external healthcare clinicians as well as academicians with expertise in Psychology, Psychiatry, Neurology, Neuropsychology, Pediatric Neurology, and Biomedical Engineering, among others The ACPN IRB serves to ensure ethical conduct of research in compliance with the aforementioned international policies and guidelines.

IRB Members:

• Dr. Taoufik Alsaadi (Chair)
• Dr. Alia Ammar (Vice-Chair)
• Dr. Samer Makhoul (ACPN)
• Mr. Ahmed Mostafa (ACPN)
• Ms. Rana Abounakad (ACPN)
• Dr. Ahsan Khandoker (Khalifa University)
• Dr. Tariq Shahrour (Sheikh Khalifa Medical City)
• Dr. Khaled Kadry (Maudsley Health Abu Dhabi)
• Dr. Fadwa al Mughairibi (UAE University)
• Dr. Lamya Turkawi (Sheikh Khalifa Medical City)

IRB Coordinator:

• Ms. Seada Kassie (ACPN)

3. Research Collaborations:

a. Academic and Scientific Research Institutions:

Khalifa University, Abu Dhabi

Zayed University, Abu Dhabi

New York University Abu Dhabi

Harvard Medical School Center for Global Health Delivery - Dubai

Imperial College London Diabetes Centre (ICLDC) - Abu Dhabi

b. Current Pharmaceutical supporters

Biogen, Inc®

Novartis®

IQVIA®

4. Guidelines for Proposed Research Studies:

No restrictions on the type of research that can be conducted as long as:

• Goal is justified and implications are identified
• Ethical considerations are met and conduct complies with guidelines of ICH - GCP and DOH Standard Operating Procedures (SOPs)
• Principal investigator meets requirements and has expertise in the study field

Note on clinical trials:

• Products/drugs must be registered with:
• The Ministry of Health Drug Control Department and DOH Medical Products Regulation Section
• Application fees apply

Note: investigational medicinal product is one that has been given marketing authorization but is being investigated for uses other than what is indicated. Does not apply to Phase 1 trials.

5. Criteria for Research:

Proposed studies must meet the following criteria:
Benefit: Does the proposed study have clear benefits to the community in which it is conducted?
Effectiveness: Will the study be effective in achieving the desired goal?
Necessity: Is the study necessary to achieve the goal or is there an alternative that won’t infringe on a competing value?
Proportionality: Is the desired goal important enough to justify overriding another principle or value?
Least infringement: Is the study designed to minimize infringement on the values that conflict with it?
Transparency: Is the Primary Investigator prepared to publicly justify their decision?


6. Ethical Considerations:

Ethics regarding human subjects:
Respect for persons: respect autonomous choices; protect those lacking autonomy
Obtain informed consent from those capable of giving consent, proxy consent
Beneficence: do not harm; maximize benefits, minimize harms
Risk/benefit assessment is conducted, clear action if adverse effects arise
Justice: fairness in distribution; treat equals equally
Recruitment of subjects is fair, vulnerable populations not simply targeted out of convenience

7. Research Ethics Application: What to include

• ACPN ethics review application form (download form)
• Detailed study protocol 
• Questionnaires and description of drugs/products that will be used (Arabic and English)
• Subject consent form (Arabic and English)
• Subject information sheet (Arabic and English)
• CVs of all investigators 
• Investigators’ certification of Research Ethics Training for Protecting Human Research Participants

8. Application Submission Procedures:

• All ethics proposals are submitted to the IRB coordinator (research.officer@americancenteruae.com), who reviews the application for completeness and confirms to investigators within five days of its receipt
• The IRB is required to give an ethical opinion on an application within 60 calendar days of the receipt of a valid application. Where the IRB considers that further information is required in order to give an opinion, the IRB may make one request in writing for further information from the applicant. The period of 60 days will be suspended pending receipt of this information
• In the case of a clinical trial involving a medicinal product for somatic cell therapy, the normal statutory time limit for review is extended to 90 days. This may be extended by a further 90 days (i.e. to 180 days in total) where the REC needs to consult a specialist group or Committee about the application

9. Ongoing Clinical Research Studies:

• Observational study to collect information on the safety and drug utilization of Fampyra® - Dr. Taoufik Alsaadi and colleagues
• A Pilot study on the prevalence of depression and anxiety among neurology patients attending ACPN – Dr. Ahmed Mohamed and colleagues
• Narcolepsy in the UAE: A Case series – Dr. Khaldoun Mozahem and colleagues
• Real world retrospective study of effectiveness and safety of Gilenya (Fingolimod®) in relapsing remitting Multiple Sclerosis in the Middle East and North Africa (FINOMENA) – Dr. Taoufik Alsaadi
• Repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of major depressive disorders: results from the UAE – Ms. Seada Kassie and Dr. Taoufik Alsaadi
• A comparison study of the use of Haptic Handwriting Tool among children with learning difficulties in the UAE – Dr. Samra Tahir and Dr. Mohamad Eid
• Can combined endurance and resistance training slow disease progression in adults with relapsing remitting multiple sclerosis? A pilot study – Ms. Helen Hughes and colleagues
• A cohort study on treatment outcome of anorexia nervosa in the UAE – Ms Carine El Khazen and colleagues
• Investigating the role of sleep-disordered breathing and its treatment on depressive symptoms in the UAE – Dr. Khaldoun Mozahem and colleagues
• Antiepileptic drugs use and major congenital malformation rate: A prospective observational cohort study: The United Arab Emirates – Dr. Taoufik Alsaadi and colleagues

10. Published Research Articles:

• Patient cost-sharing for ambulatory neuropsychiatric services in Abu Dhabi, UAE – Dr. Yousef Abouallaban and colleagues
• Potential factors impacting health-related quality of life among patients with epilepsy: Results from the United Arab Emirates - Dr. Taoufik Alsaadi and colleagues
• Depression and anxiety as determinants of quality of life in patients with multiple sclerosis: The United Arab Emirates – Dr. Taoufik Alsaadi and colleagues
• Suicidal ideation Is associated with altered variability of fingertip photo-plethysmogram signal in depressed patients– Dr. Yousef Abouallaban and colleagues
• The rapidly changing landscape of multiple sclerosis immunomodulatory therapy a retrospective chart review in The United Arab Emirates – Dr. Taoufik Alsaadi and colleagues
• Impact of working memory and cognitive functioning on specific language impairment (SLI) – Dr. Samra Tahir and colleagues
• Working memory in children with intellectual disability (ID) - Dr. Samra Tahir and colleagues