South & East Mediterranean College of Oncology
First SEMCO-ASCO Conference
National Training Centre, Cairo, Egypt
5-6 April 2007

Second SEMCO-ASCO Conference
Advanced Course
Ain Shams Training Centre, Cairo, Egypt
26-28 March 2008

Third SEMCO-ASCO Conference
Sesme, Izmir, Turkey
20-22 November 2008

Fourth SEMCO-ASCO Conference
Hilton Hotel, Cairo, Egypt
15-17 April 2009

Fifth SEMCO-ASCO Conference
Abu Dhabi, UAE
25-26 February 2010

Sixth SEMCO-ASCO Conference
Ramses Hilton Hotel, Cairo, Egypt
27-28 January 2011

Seventh SEMCO-ASCO Conference
Cancer Care in the Older Population
Radisson Blu Hotel
18-19 October 2012

Palestine Hotel, Alexandria, Egypt
5-7 December 2007

Second Anual African Breast Cancer Conference
Hilton Hotel, Cairo, Egypt
17-19 March 2009
Thursday 27th January 2011

Welcome                                                                        SEMCO & ASCO Faculty
Introductory notes    
Ahmed Elzawawy
Course Introduction     
Robin Zon
Session I: Global Overview - Need for International Clinical Trials
Robin Zon

1. Background information
2. Disparity of research available for ethnic groups
3. Global review of clinical research
4. Public Health differing objectives and positions of industry-oriented trials

Session II: Overview of Cancer Issues


1. Research and Cancer in Egypt   
2. Needs of Networking

Hussein Khaled
Nihal El habachi
Session III: Perspectives of Sponsors

1. Academic perspective
2. Government perspective
3. Cooperative group perspective
4. Industry perspective
Jo Anne Zujewski

Panel Discussion
Panelists: Hussein Khaled, Rabab Gaafar, Robin Zon, JoAnne Zujewski, Alexander Enui

AHmed Elzawawy


Session IV: Ethical Considerations

Alexandru Eniu

1. Tenets of Good Clinical Practice (GCP)- ICH.E6 document
2. Declaration of Helsinki
3. Role and responsibility of Ethics Committee/IRB
4. International standards for informed consent
5. Availability of drugs before and after the trial

Alexandria Clinical Research Center  "An Egyptian Experience"
Nadia Zaki

Session V: Role of the Oncology Research Team
Robin Zon

Principal investigator as Team Leader
2. Clinical Research Associate / Research Nurse
3. Data Manager /Data Entry Clerk
4. Nurse / Resident
5. Pharmacist
6. Support staff (administrative)
7. Support specialists (imager, surgeons, etc.)
8. Trial Participant, according to GCP

Session VI: Clinical Trial Design and Methodology   
JoAnne Zujewski

The Protocol Document: a reflection of trial design
1.a. Formulating a research hypothesis
1.b. Stating the objectives and selection of endpoints
       (incorporating biomarkers,  molecular targets, correlative signs, etc.)
1.c. Design elements of a successful clinical trial
1.d. Example of a successful clinical trial design
2. Phase 0 to Phase IV. What is right for you

Session VII: Planning and surviving a formal audit
Rabab Gaafar

1. Clarification of sponsor role, CRO
2. Importance of staff training before, during and after each trial as protocols evolve
3. Coordination of regulatory compliance

Message of the day

Friday 28th January 2011

Session VIII: Regulatory Issues - International perspective
JoAnne Zujewski

1. International considerations for multi-site trials
2. Generally accepted standards for clinical trial approval
3. Safety and surveillance reporting for adverse events, coding, etc.
4. International insurance requirements for patients
5. Patient protections in Europe - Directive 2001/20/EC

Session IX: Regulatory Issues - Regional Perspective
Tamer Hefnawy

1. Reporting requirements of local regulatory bodies
2. Approval process for use/importation of drugs and required endpoints
   (FWAs, trial   approval, shipping of drugs, etc.)
3. Legal aspects of clinical trials (patients, investigators, sponsor)

Session X:Selecting a multi-site Clinical Trial to activate
Alexandru  Enui

1. Financial feasibility
    1.a. Elements of a budget - required human/physical resources
    1.b. Sources of funding (government, charity, cademic/institutional)
    1.c. Planning for costs not covered by study sponsors
    1.d. Responsibility of patient care costs
2. Define patient population for the study
3. Implementation feasibility - consider resources, staff and
    technological requirements, available patient population, etc.
4. What is being done to standardize procedures and data across sites?


Palliative care research priorities and clinical trials in South & East Mediterranean Region   

Joe Harford
Session XI: Enrollment Methodology   
Atef Badran

1. Pre-screening patients
2. Accrual Strategies

Session XII: Promoting a Clinical Trial   
Robin Zon

Developing tools for referrals and recruitment to trials, including best practices in working with referring physicians

Interactive  Discussion:
Clinical  Researches and increasing affordability of Cancer Treatment: Breast Cancer as research  model  
Introductory talk and Moderator:
Ahmed Elzawawy

Introductory talk: Clinical Trials, researches and  lowering total cost of appropriate cancer treatment:  Needs,  barriers  and  examples of proposals
Discussants  (Robin Zon,  JoAnne Zujewski , Alexander Enui , Sherif Omar , Hussein Khaled, Rabab Gaafar,  Joe Harford, Nehad El Habachi, Atef Badran and attendees.

Closing remark

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International Clinical Trials Workshop (ICTW-2)
27 - 28 January 2011, Cairo