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Developing an Introductory Clinical Research Course
Transcript of Developing an Introductory Clinical Research Course
Phases of drug development
History and milestones in clinical research
Regulations and guidelines (sFDA / GCP)
Roles and key players
Protecting human subjects
Current issues in clinical research
Content Clinical research is a relatively new concept in the Kingdom of Saudi Arabia (KSA)
Massive efforts are being invested in organizing the clinical research process in the Kingdom.
Pharma & healthcare spending is expected to increase
SAR 9.94 billion (US$2.64 billion) in 2008
SAR 13.09 billion (US$3.48 billion) in 2013
(Business Intelligence Middle East, 2010).
This academic plan centers on developing a course for medical students and allied health professionals at the National Guard Health Affairs (NGHA), the leading medical complex in the Kingdom, and its affiliated institutions. External & internal forces indicate positive future for R&D in KSA and emphasizes the need for an introductory clinical research course.
High quality training programs can raise industry standards.
Clinical research in KSA has the potential to emerge from the periphery and become part of the mainstream of drug development.
As part of the course curriculum, would it enhance the learning experience if students “shadow” a clinical research mentor to gain a better understanding of the profession?
Thank you! Should students be expected to memorize the regulations and policies governing clinical research or is it enough to have a general understanding of them? Questions Should this course be targeted to medical students only or is it beneficial to include students from other health professions? Conclusion External
The countries lifestyle changes (modernization) has led to prevalence of disease and prompted need for clinical research
Global pharmaceutical companies such as Eli Lilly, Pfizer, Bristol-Myers Squibb, Cyanamid, Merck, Upjohn, Cilag, and Syntex are conducting multicenter studies within the Kingdom
Saudi Ministry of Health is the main regulatory authority yet it does not fully oversee clinical research management.
The Kingdom of Saudi Arabia has a vast pool of scientific, pharmaceutical, and medical professionals, but the availability of trained clinical research professionals is far less than the demand. Internal
Influences Saudi Food & Drug Administration (sFDA)
Main regulatory body of clinical trials conducted in KSA
National Guard Health Affairs (NGHA)
Mission, vision, & core values:
“Recognized as an internationally acclaimed center of
excellence to enhance individual and public health status.”
Promoting patient care research & timely access to treatment
Fosters an environment of education & research Purpose Introduce physicians, medical students, and health professionals to patient-oriented clinical research as it pertains to the healthcare market in Saudi Arabia.
Encourage medical students, fellows, young faculty, and other interested health professionals to pursue patient-oriented research as a portion of their academic activities.
ACADEMIC PLAN EDUCATIONAL ENVIRONMENT Learners This course will be of interest to
and other health professionals interested in clinical research Instructional Resources Lecture notes Discussions Skype Live streaming video Video conferencing Laptop Texbooks Regulatory guides Internet YouTube Mentor shadowing Research conferences Ethical guides Blogs Social media Sequence Introduce fundamentals & principles.
Understand the overall process of R&D.
Provide a brief historical overview of the field.
Explain research methodology, protocol design, management, & ethical conduct.
Identify current issues to keep up to date in the field.
Instructional Processes Didactic lectures
Facilitated group discussion
Tutorials & case studies
Forum conferences featuring presentations by investigators, coordinators, monitors, and other clinical research professionals focusing on patient-oriented research
Assessment & Evaluation Assessment
Understanding and comprehension conducted through a series of short quizzes
Students must pass with 70% correct answers.
Students will complete course evaluation near end of course.
Gain insight on students’ views and experiences
Course usefulness, sequence, teaching methods, learning activities, real-world applicability
Meet with students’ needs and expectations. Adjustment Course curriculum will be adjusted as necessary to adapt to students' needs and to meet with industry demands accordingly.
Curriculum modification will be based on
Course evaluation from students
Student and faculty feedback
Industry & market changes
Other influential factors
Educational Process Designed with methodical planning following Bloom’s Taxonomy.
Create Saudi Clinical Research Education in Sociocultural Context
Educational Outcomes 1. Gain general knowledge of the clinical research process
2. Appreciate the value of clinical trials.
3. Demonstrate ethical awareness towards clinical research
4. Consider the importance of drug safety and protecting human
5. Analyze research articles & utilize emerging data as it applies in
the healthcare profession.