• The Clinical Research Unit (CRU) at the Naef K. Basile Cancer Institute (NKBCI) is in charge of coordinating innovative research that relates to the better understanding, prevention, detection and treatment of cancer. By providing support for basic, translational and clinical research, we aim at delivering breakthrough therapies that will ultimately lead to improved patient outcomes.  The program aims at establishing collaborative research throughout different disciplines with a strong team of researchers to be able to better diagnose e and provide precise targeting in cancer treatment. The CRU is in charge of coordinating research activities with the Institutional review board (IRB), Office of Grants and Contracts (OGC), finance department, human resources, sponsors, and others.

• Initiated in 2013, the Clinical Research Unit was established at the Naef K. Basile Cancer Institute, with the Data management as in one entity and it contained the previously established Tumor Registry (1983-2018). The tumor registry aimed at gathering a list of all cancer patients encountered at AUBMC, yet its information was restricted to basic demographics and tumor information, that would serve the National Cancer registry. While, it was essential to identify patients for specific diseases, any cancer research necessitated additional data collection to support retrospective studies. As a result, and since the volume of patients treated and diagnosed with cancer over the past decade has been continuously increasing, founding this unit was essential for researchers to collaborate and combine basic, translational, and clinical research to explore ways to prevent, control, and treat cancer. The clinical research unit manages current research and ongoing clinical trials working hand in hand with a multidisciplinary team of health practitioners, nurses, doctors, and researchers, our aim is to support and improve cancer research, analysis, and data management.
• The AUBMC cancer registry is an information system designed for the collection, management and analysis of data on patients with diagnosis of a malignant or neoplastic disease (cancer). Cancer registration is a global method to report cancer incidence, the types of cancer that occur (site and morphology), and demographic information.
• The Oncology database, initiated in 2014, is an elaborate version of the Tumor registry. Patients are consented upon their diagnosis, which enables the research team to contact them for updates in a timely manner. Data management plays a major role in collecting data on diagnostic findings, treatment, and follow up in the oncology database through the recently developed E-forms, adopted from the latest American Society of Clinical Oncology (ASCO) cancer-specific forms.

RESEARCH ACTIVITY (AVERAGE ANNUAL NUMBERS):

135  Ongoing studies
80  Publications in recognized journals
45  Grants for research studies for more than 2 million USD per year (2018)

CONFERENCES AND MULTI-DISCIPLINARY GROUP CONSULTATIONS:

7  Annual National Accredited Continuing Medical Education activities
8  Multidisciplinary weekly meetings

Clinical research dates back to 1971-1972, where the main research activities were in thalassemia and leukemia. In 1974, the Hematology – Oncology division hired two research assistants, a research fellow, a secretary and a nurse. A two-year research grant from the Lebanese National Council for scientific research that relates to the study of the so-called “Lebanese lymphoma”. Up until the 1982, around 10 oncology publications and 10 national and international conferences were done per year. NKBCI now includes 10 full time Hematology-Oncology attendings and 5 radiation oncologists, with sub-specialties in specific cancers and over 100 publications annually. Extensive collaboration exists with non-NKBCI members including other clinical departments and basic science researchers in addition to international collaborators like Memorial Sloan-Kettering Cancer Center (MSKCC) and MD Anderson Cancer Center (MDACC). The more recent research activities are characterized by an increase in prospective and investigator-initiated studies.

The clinical research unit, with its renowned researchers aims to attract the most prominent research investigations including Phase I, Phase II /III studies. This unit is formed of a research team that includes research fellows, nurses, data managers and research coordinators.

Basic Science Research	Brain Tumor Center of Excellence for Research	Breast Center of Excellence for Research	Gastrointestinal and Genitourinary Cancer Research

Gynecologic Oncology Research	Hematologic Oncology, Hematological, Bleeding & Thrombotic Disorders Research	Neuroendocrine Tumors Research	Radiation Oncology Research

Thoracic and Lung Specialized Cancer Research

The clinical research unit, with its renowned researchers aims to attract the most prominent research investigations including prospective and retrospective studies. This unit is formed of a research team that includes research fellows, nurses, data managers and research coordinators.

Basic Science Research	Brain Tumor Center of Excellence for Research	Breast Center of Excellence for research	Bone Tumors Research

Cancer Prevention Research Training	Community Health Research	Covid-19 Research	Dermatological Tumors Research

Gastrointestinal and Genitourinary Cancer Research	Genomic Profiling Research	Gynecologic Oncology Research	Hematologic Oncology, Hematological, Bleeding & Thrombotic Disorders Research
Immunotherapy Research	Neuroendocrine Tumors Research	Palliative Care Research	Thoracic and Lung Specialized Cancer Research
Radiation Oncology Research

The Naef Basile Cancer Institute’s clinical research unit is a member of the following research network:

Union of International Cancer Control : UICC

The UICC has a membership base of over 1100 organizations in more than 170 countries, representing the world’s major cancer societies, ministries of health and patient groups. It includes influential policy makers, researchers and experts in cancer prevention and control. They aim at supporting the cancer community to reduce the global cancer burden, by conveying cancer control events and initiatives, capacity building, and use advocacy resources to drive change in the future.

Oncodistinct Clinical Trials Network:

Oncodistinct group was founded in 2015 by a multidisciplinary group of investigators with an expertise in early drug development and clinical research. The network includes more than 20 cancer centers and university hospitals from nine countries, based in Jules Bordet institute – Belgium.  The network’s goal is to address the current challenges in oncology by developing and sharing innovative clinical studies within the group across different countries and sites.

European Cancer Network: Founded in 1979 for the improvement of communication and a growing cooperation between cancer institutes throughout the European continent, today the OECI regroups many European cancer research and care centres – both large and small- from almost all the EU countries and several major cancer centres from Chile, Colombia, Jordan, Lebanon, Russian Federation, Tanzania, Turkey, Ukraine and Viet Nam.

Research Collaborations:

• Memorial Sloan Kettering Cancer Center Clinical Trials: New York – USA
• MD Anderson Cancer Center Clinical Trials: University of Texas – USA
• King Hussein Cancer Foundation Cancer Center Clinical Trials Unit: Jordan
• Prostate Cancer Research Institute : California – USA
• Sarah Canon Cancer Research Institute- HCA Healthcare : UK

Facility of research:

​​​​​​​​​​The Clinical Research Institute (CRI) was established in 2010 to provide the required infrastructure to support and promote innovative clinical research and collaborative activities at the Faculty of Medicine (FM) and AUBMC, thus leading to discoveries, advancement of clinical practice, and improvement in patient care outcomes. The CRI offers a wide range of services to investigators through its various units, programs and centers. Visit the CRI’s webpage at: https://www.aub.edu.lb/fm/cri

The NKBCI Clinical Research Unit team includes research fellows/assistants, a data manager, clinical research coordinators and is headed by the director, Dr. Ali Shamseddine.

Dr. Ali Shamseddine, Clinical Research Unit Director and Data Management Unit Director

Dr Shamseddine is currently Professor of Clinical Medicine and Director of Gastrointestinal / Genitourinary Cancer Program, at NKBCI and previously the Head of Hematology /Oncology Division 2000-2017. Trained at the American University of Beirut he is also a fellow of Royal College of Physician (London).

Professor Shamseddine served as a Chair of the hospital committee on cancer 1997-2011 as well as the Director of the Tumor Registry at the Medical Centre and Data Management Unit since 2014. He was appointed for the position of Vice President of the National Cancer Registry (NCR) from 2005-2010. He served as WHO advisor in epidemiology during 2013-2016. He is the Founder and Chair of the Advisory Board of Arab Collaborative Haematology-Oncology Group (ACHOG). Dr. Shamseddine also served as president of the Lebanese Society of Medical Oncology (LSMO 2006-2008) and chair of European Arab Society of Oncology Prostatic Group in Lebanon (2010-2013). He is currently the chair of prostatic cancer session at the European School of Oncology (ESO) 2016, 2017 and 2018. He is member of the scientific committee and active faculty of the World Gastrointestinal Cancer Conference (ESMO) 2017 & 2018. Recently (April 2018) Dr Shamseddine was nominated By ASCO to serve as member of an expert panel charged for development of clinical guidelines for the treatment advanced stage colorectal cancer

Dr Shamseddine has published more than 220 papers in peer-review journals, and a book reporting the trends in cancer at the American University of Beirut over 20 years (1983–2003). His research interests include epidemiology of cancer in Lebanon and the region, gastro-intestinal and prostatic cancers. His ongoing clinical research includes studying the outcome of chemo-immunotherapy with radiation therapy in GI cancers.

Ms. Maya Charafeddine, MPH

Maya Charafeddine joined the Naef K. Basile Cancer Institute as a Data manager in 2013, she currently supervises and manages research, clinical trials and data analysis in Oncology. Maya holds a teaching diploma in health education and a Master’s degree in Epidemiology and Biostatistics from the American University of Beirut. Before joining AUBMC, she worked in London (United Kingdom) as a data quality consultant/analyst at the National Health Services (NHS), and in Data monitor/ Informa Healthcare as an Epidemiologist. In addition to her data analysis and involvement in biostatistics, Mrs. Charafeddine has co-authored many peer-reviewed publications particularly in epidemiology.

Ms. Lama Zahreddine, MS

Lama Zahreddine joined the Naef K. Basile Cancer Institute (NKBCI) in 2020 as a Program Coordinator for the Palliative and Supportive Care Program. In 2022, Lama has taken on a new role at NKBCI as a Clinical Trials Coordinator.

She holds a Bachelor of Science from the American University of Beirut (AUB) with a Major in Medical Laboratory Sciences and a Minor in Public Health (2008); and a Master of Science in Microbiology and Immunology (2011) also from AUB. Lama completed one semester of the PhD program in Clinical-Bioanalytical Chemistry/Cellular and Molecular Medicine Specialization at Cleveland State University, OH in 2012. Prior to joining NKBCI, she worked with the Anesthesiology Department at AUB Medical Center (AUBMC) in 2013 as a Clinical Research Coordinator. She then moved to the Children’s Cancer Institute, AUBMC in 2014 and served as the Institute Clinical Trials Coordinator.

Lama has established herself in the healthcare sector and particularly the research field of expertise (Basic as well as Clinical). She has also been involved in the management of Medical/Patient Support Programs and the coordination of various phases of Clinical Trials throughout their stages of development (sponsor-initiated and investigator-initiated).

Ms. Monita Darazi, RN, MSN

Monita Darazi joined the Naef K. Basile Cancer Institute on February 2014 as a clinical trial coordinator. She holds her BS in nursing and Master of Science in nursing administration from the American University of Beirut. Mrs. Darazi had 9 years’ experience (in direct patient care (Neonatal ICU) and 3 years’ experience in genetic research in pediatric cardiology) as well as operation and quality management at Children heart center at AUBMC. She completed her Master’s residency at johns Hopkins University hospital internal medicine nursing administration. Currently, she is managing ad coordinating phase II and III clinical trials (Sponsor initiated and Investigation sponsored trials) at NKBCI in terms of study project management: conception and initiation, planning, execution, performance/monitoring, and project close. In addition, she is coordinating and assisting clinical research fellows in observational, prospective and retrospective studies. Finally, she is building, developing, coordinating and integrating the oncology database with the help of EPIC team into the EPIC system.

Ms. Kristel Dagher, RN, MBA

Kristel Dagher joined the Naef K. Basile Cancer Institute on October 2023 as a Clinical Trial Coordinator. She holds a Bachelor of Science in Nursing from the American University of Beirut and a Master of Business Administration in Management from Sagesse University. She got  her Lean Six Sigma Black Belt certification from the Six Sigma Global Institute in 2022 and currently persuing a Project Management Professional Diploma in AUB. Mrs. Dagher has 11 years of experience in direct patient care and administrative work at the Naef K. Basile Inpatient and Ambulatory Chemotherapy Unit, and 2 years of experience as a Nursing Manager for the Oncology Department in Almoosa Specialist Hospital in Saudi Arabia. She has been a speaker, panelist, and moderator in several national and international conferences and workshops related to her field of expertise. Currently, she coordinates sponsor-initiated and investigator-initiated trials in phases Ib, II and III at the NKBCI.

Ali Shamseddine, MD
Director – Data Management Unit
As04@aub.edu.lb
Ext: 5150

Maya Charafeddine, MPH
Data Manager
Mc16@aub.edu.lb
Ext: 5110

Monita Darazi, RN, MSN
Clinical trials Coordinator
Ma99@aub.edu.lb
Ext: 7804

Lama Zahreddine, MS
Clinical trials Coordinator
Rb62@aub.edu.lb
Ext: 7803

Kristel Dagher, RN, MBA
Clinical trials Coordinator
Kd17@aub.edu.lb
Ext: 8437