CRP108 - Clinical Trial Design and Pharmacology

Outline info
Semester
School
Last revision date 2017-05-29 00:41:37.716
Last review date 2017-07-17 00:16:35.667


Subject Title
Clinical Trial Design and Pharmacology

Subject Description
A clinical trial is a carefully planned and scientifically sound experiment. This course provides students with an opportunity to learn and understand the rationale of designing, conducting and successfully completing a clinical trial. Students gain understanding of drug action, metabolism and clearance.

Credit Status
One credit towards CRQ program.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

• Develop knowledge of drug action, metabolism and clearance
• Identify and mitigate risks of bias in study designs
• Trial design approaches for comparative effectiveness and pharmacokinetic studies
• Calculation of pharmacokinetic principles including half-life, clearance, volume of distribution, area under the curve
• Identify the Advantages and disadvantages of various types of clinical research study designs
• Identify sources and types of adverse drug reactions
• Execute critical appraisal activities including evaluating the advantages, challenges and the potential risk of bias in clinical trial protocols and the medical literature.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on http://library.senecacollege.ca for further information regarding cheating and plagiarism policies and procedures.

Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecacollege.ca.

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Prerequisite(s)
none

Topic Outline
1. Introduction to clinical research, pharmacology, receptors and drugs
2. Drug absorption, distribution, metabolism and elimination
3. Protecting participants in research, bias, blinding, and randomization 
4. Pharmacokinetics and pharmacokinetic study design
5. Drugs and the central nervous system
6. Drugs and the autonomic nervous system
7. Trial design; picking a control arm and selecting outcome measures
8. Cardiovascular drugs
9. Natural health products
10. Hormones and endocrinology drugs
11. Inflammation and non-steroidal anti-inflammatory drugs
12. Cancer and chemotherapy drugs
13. Adverse drug reactions and sources of variability in trial data
14. Development pharmacology and clinical trial design in children

Mode of Instruction
Lectures, audio-visual presentations, case studies, group work, in-class exercises. Students can expect to spend approx. 2-3 hours outside of class reading, doing assignments, etc.

Prescribed Texts
None

Reference Material
Class handouts and notes

Required Supplies
None

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
OR
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online (http://www.senecacollege.ca/academic-policy) or at Seneca's Registrar's Offices.


Modes of Evaluation
• Risk of bias assignment: 10%
• Pharmacokinetics assignment: 10%
• Presentation: 20%
• Midterm exam: 20%
• Final exam: 40%

Essential Employability Skills:
• Apply a systematic approach to solve problems.
• Written and verbal communication skills conveying medical information relevant to clinical research
• Locate, select, organize, and document information using appropriate technology and information systems.
• Analyze, evaluate, and apply relevant information from a variety of sources.
• Adapting communication skills to a variety of audiences including the public and the scientific communities
• Show respect for diverse opinions, values, belief systems, and contributions of others.
• Interact with others in teams and develop effective working relationships and the achievement of goals.
• Manage the use of time and other resources to complete projects.
• Take responsibility for one's own actions, decisions, and consequences.

Assignments
• Assignments are due at the beginning of the class on which they are due.
• A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
• Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
• Assignments are to be prepared by computer.

Absenteeism and Exams
• Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
• Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
• There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
• All written work should demonstrate the following characteristics for clarity and conciseness:
• Writing is consistent with the rules of English grammar
• Spelling and punctuation are correct
• Sentences are structured correctly
• Main ideas are supported with specific, relevant examples and reasons
• Work flows logically through supporting statements/paragraphs
• Work is arranged in correct format (e.g., as a report, essay)
• Up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
• Students must use the standard, APA style for quoting sources.   Help is available at:  http://library.senecacollege.ca


Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.

PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS


Approved by: Denis Gravelle