Thursday 27th January 2011
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07:15
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Registration
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08:15
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Welcome SEMCO & ASCO Faculty
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08:25
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Introductory notes
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Ahmed Elzawawy
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08:35
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Course Introduction
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Robin Zon
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08:45
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Session I: Global Overview - Need for International Clinical Trials
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Robin Zon
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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
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09:15
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Session II: Overview of Cancer Issues
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09:15
09:45
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1. Research and Cancer in Egypt
2. Needs of Networking
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Hussein Khaled
Nihal El habachi
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10:00
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Coffee Break
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10:30
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Session III: Perspectives of Sponsors
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1. Academic perspective
2. Government perspective
3. Cooperative group perspective
4. Industry perspective
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Jo Anne Zujewski
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11:30
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Panel Discussion
Panelists: Hussein Khaled, Rabab Gaafar, Robin Zon, JoAnne Zujewski, Alexander Enui
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Moderator
AHmed Elzawawy
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12:30
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Lunch
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13:30
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Session IV: Ethical Considerations
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Alexandru Eniu
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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
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14:15
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Alexandria Clinical Research Center "An Egyptian Experience"
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Nadia Zaki
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14:45
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Session V: Role of the Oncology Research Team
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Robin Zon
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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
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15:15
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Coffee Break
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15:30
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Session VI: Clinical Trial Design and Methodology
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JoAnne Zujewski
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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
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16:15
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Session VII: Planning and surviving a formal audit
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Rabab Gaafar
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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
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17:30
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Message of the day
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Friday 28th January 2011
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09:00
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Session VIII: Regulatory Issues - International perspective
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JoAnne Zujewski
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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
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09:30
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Session IX: Regulatory Issues - Regional Perspective
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Tamer Hefnawy
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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)
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10:15
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Session X:Selecting a multi-site Clinical Trial to activate
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Alexandru Enui
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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?
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11:30
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Coffee break & Prayer time
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13:00
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Palliative care research priorities and clinical trials in South & East Mediterranean Region
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Joe Harford
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13:30
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Session XI: Enrollment Methodology
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Atef Badran
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1. Pre-screening patients
2. Accrual Strategies
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13:45
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Session XII: Promoting a Clinical Trial
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Robin Zon
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Developing tools for referrals and recruitment to trials, including best practices in working with referring physicians
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14:30
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Interactive Discussion:
Clinical Researches and increasing affordability of Cancer Treatment: Breast Cancer as research model
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Introductory talk and Moderator:
Ahmed Elzawawy
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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.
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15:30
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Closing remark
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