Translational Research

1/13/2019 Module 2: Exercise 1 - Translational Research

https://asu.instructure.com/courses/5880/assignments/96463?module_item_id=265977 1/3

Translational research” is a term that has been used in the scientific community for about 20 years, and is also a process that crosses many disciplines and meanings. Please read the attached article regarding the definition of translational research.

In this exercise, students will use their knowledge and perspective of translational research to develop a staffing model for an early phase I research site. Because “translational research” is interpreted in many different ways, I expect that each student will define the term in the way that she or he will then develop into her/his staffing budget. Consequently, I will be grading this assignment for consistency and reasonable assumptions along with justification. There is no “right” or “wrong” answer, I expect that you will use due diligence to make decisions on salaries, training and other requirements to establish a quality research module.

You are currently the manager of the clinical research department in a busy (nonprofit) oncology practice). As such, you are often tasked with planning new ventures and directions for the research department.

To everyone’s surprise a patient donates a substantial amount of money to the practice, with the directive that $20 million dollars will be used to start a translational research module within the research department. The Vice President of the practice has tasked you with investigating a model for an early Phase I translational research department and developing a staff start-up budget and justification. These are the details of your assignment:

3-4 pages total (5 points) References and citations if you use any literature or other material (5 points) Content:

1. 2-3 paragraphs defining translational research as it relates to early translation of a drug from animal studies to human studies (T1 research) (20 points)

2. 2-3 paragraphs exploring the overall resource needs of a translational research facility that conducts early Phase I studies (include what happens just prior to a Phase I study and the definition of Phase 0 studies) (20 points)

3. Your first year budget for staffing will be $1.5 Million dollars for support of 25 people. Your goal is to open 5 new studies in the first 4 months and another 15 in the next 8 months – how will you spend the money? (45 points – reasonable numbers, justification, and salaries using internet resources and academic research)

4. 1 paragraph conclusion discussing your budget and why it is reasonable. (5 points)

Please complete a table similar to the one below:

Staff Position Justification Annual Salary Benefits (33%)

Salary & Benefits

Investigator This position will focus on review of the basic sciences of the development of the drug. S/he will collaborate with

$100,000 $33,000 $133,000

1/13/2019 Module 2: Exercise 1 - Translational Research

https://asu.instructure.com/courses/5880/assignments/96463?module_item_id=265977 2/3

Exercise 1 Translational Research

the clinical researcher and the basic scientist to ensure safety…

Totals

100 total points possible.

**Keep in mind that you are defining the type of module that you will be staffing and justifying through your definition of translational research.

1/13/2019 Module 2: Exercise 1 - Translational Research

https://asu.instructure.com/courses/5880/assignments/96463?module_item_id=265977 3/3

Total Points: 100.0

Criteria Ratings Pts

5.0 pts

5.0 pts

20.0 pts

20.0 pts

45.0 pts

5.0 pts

3-4 pages 5.0 to >4.0 pts Proficient appropriate page numbers

4.0 to >1.0 pts Competent

1.0 to >0 pts Novice

References and Citations

5.0 to >4.0 pts Proficient appropriate and accurate references and citations

4.0 to >1.0 pts Competent not all citations in place

1.0 to >0 pts Novice

Definition of T1 research

20.0 to >15.0 pts Proficient well done and accurate and referenced as needed

15.0 to >9.0 pts Competent missing significant information

9.0 to >0 pts Novice missing information and purpose

Resource needs

20.0 to >15.0 pts Proficient well done and accurate

15.0 to >9.0 pts Competent missing significant information

9.0 to >0 pts Novice missing information and purpose

Budget justification

45.0 to >40.0 pts Proficient well done and accurate

40.0 to >29.0 pts Competent missing significant information/understanding

29.0 to >0 pts Novice missing information and purpose

Conclusion 5.0 to >4.0 pts Proficient well done - aligned with content

4.0 to >1.0 pts Competent missing information

1.0 to >0 pts Novice

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