Within 90 days of appointment, CT2 trainees will be required to submit a 6 page project plan, structured in the format of a standard R01/R21 application to be reviewed by the Executive Committee which will serve as the basis for the Committee’s assessment of their progress and performance throughout the 2-year period of training.
Trainees will be consistently evaluated throughout their appointment term. Formal reviews (in the form of a presentation in front of the other trainees, mentors and Executive Committee) are required at months 8 and 20.
The ability to prepare a cogent and clearly written research proposal is essential to the trainee’s ability to assume a leadership position in cancer drug development in academia or industry. Within the first 18 months, trainees are required to prepare a mock NIH application which will is critiqued by an
ad hoc group of faculty members, acting as a typical Study Section, and provide written feedback to the fellow. Fellows may use a real grant application if they plan to submit one.
The UC San Diego School of Medicine has established a specialized program to doctoral candidates, postdoctoral fellows and junior faculty pursuing a career in clinical or translational research. Scholars in this program complete a series of courses offered in a modular format. The CT2 training program cross-registers its trainees in the CREST program and requires that they complete
5 of the following:
Year 1 Modules||
Year 2 Modules|
|Epidemiology I||Biostatistics I*|
|Epidemiology II||Biostatistics II*|
|Patient Oriented Research I||Health Services Research|
|Patient Oriented Research II||Data Management and Informatics|
|Research Budgeting and Project Management|
|Personal Development Skills|
Feedback from previous appointees has indicated the high value of Biostats courses I and II. As such, both of these courses are now required for all trainees. The Scientific Communication module focuses on grant writing, scientific writing and presentation skills, is not required but is
highly recommended for all Trainees; Patient Oriented Research I and II are recommended for MD Trainees.
The full CREST curriculum is designed to be delivered over two years and is comprised of eight modules which cover the principles of epidemiology, biostatistics, patient-oriented research (two modules each), health services/outcomes research, and career development (one module each). Each course is designed to be given over one academic quarter and is comprised of 10 weekly, 2-hour periods of instruction which are given in the early evening. The format for instruction includes a combination of didactic lectures, group discussions and hands-on computer-based training. Once-a-week evening classes allow the scholars to focus on their primary research projects during the work week with minimal interruption.
Since trainees enter the program with a variety of different backgrounds, two tracks are offered through the CREST program. In Track I Trainees take only a subset of 5 of the courses; in Track 2, Trainees take the entire set of 10 courses and earn a Certificate in Clinical Research upon completion (20 units total). A third option, which requires all courses listed above, an applied quantitative analysis course, two electives and an independent project, results in a Masters degree in Clinical Research (40 units total). Feedback from current trainees has revealed a strong interest pursuing the Masters degree. CT2 trainees may elect to participate in either Track I, II/Certificate in Clinical Research or pursue the Masters Degree.
A detailed description of the CREST coursework is described below:
Courses And Seminar Topics Available Through The CREST Program
Scholars will recognize and understand different types of epidemiologic study designs, the relative strengths and limitations of each, and the proper choice of study design in conducting their own research. They will also be able to identify and calculate the correct measure of risk for each study design. Participants will recognize major sources of bias, confounding, interaction and misclassification, and understand design and analysis methods of dealing with each. They will also be familiar with criteria to differentiate association from causation, and understand the components of causality. Participants will conclude this course with a written final examination.
Scholars will build on the content of Epidemiology I by attending guest lectures given by epidemiologists currently active in their field. Both methodology and content will be addressed in these guest lectures including topics such as smoking studies, genetic epidemiology, reproductive epidemiology, ecological studies, and the epidemiology of violence. Students will also gain an understanding of health disparities in epidemiologic research and be exposed to additional and advanced epidemiologic methods such as meta-analysis and cluster analysis. Participants will become familiar with advanced epidemiological issues and understand how study designs are practically applied in specific content areas. Students conclude this course with a comprehensive written research proposal that could be submitted for funding.
|Patient Oriented Research I|
Develop and apply the theory of clinical trial design and analysis, discuss the practical issues of implementation of clinical trials including recruitment, describe issues of monitoring trials and working in cooperative groups. The scholar design and present to a group of peers a concept sheet for phase II/III clinical trial.
|Patient Oriented Research II|
This course will review the ethics and basic regulatory issues for research involving human subjects; the principles of data management for clinical research, including architecture, access and confidentiality, and integrity of databases; and skills in graphic and verbal presentation of research data. Scholars will prepare a mock submission to the IRB for peer review and practice presenting graphic and tabular data.
Understand and apply the principles of measurement of clinical data, data types, and identification of statistical methods appropriate for analysis of a given clinical data set. Assemble clinical datasets in formats suitable for analysis by NCSS or other comparable statistical packages. Conduct graphical and numerical exploratory data analysis, comparative tests of categorical, ordinal, and continuous data, linear and logistic regression analysis, and survival analysis by life table and Kaplan‑Meier techniques.
Scholars will understand and conduct more advanced biostatistical analyses including: ANOVA, multiple linear and logistic regression, survival analysis, and Cox proportional hazards modeling. The scholar will also be familiar with person-time rate analysis with Poisson regression and develop a conceptual understanding of major multivariate methods. Quantitative aspects of decision analysis and cost-effectiveness analysis will be covered. Analysis of survey research data will focus on measures of reliability and validity and on sampling designs.
|Health Services Research |
Scholars will evaluate relevant outcomes in patient-oriented research from the patient (quality of life) and societal (economic) perspectives and locate potential resources for assessing the relevant outcomes in a wide variety of study designs. They will also be able to describe the relative strengths of different health services research approaches to a clinical problem. Finally, they will understand the components of clinical practice guidelines, including patient preferences, and how these guidelines both depend upon as well as inform patient-oriented research.
|Research Budgeting/Project Management|
Cover regulatory requirements associated with conducting clinical research; budgeting and common overheads; federal and state reporting requirements; possible penalties for administrative negligence; and best practices in common administrative processes. Relationships with external funding agencies, federal agencies involved in clinical research funding, their respective missions, organizational structure, and funding practices.
|Scientific Communication |
Scholars will learn the fundamentals of clear scientific writing and oral presentation of scientific work. They will also learn how to write an NIH-style grant including all components of a grant.
Trainees are required to take a program-approved Ethics course offered during the Fall, Winter and Spring quarters through the
Research Ethics Program. This course satisfies the NIH requirement for instruction in the responsible conduct of research. Topics include roles and responsibilities of researchers, data collection and ownership, issues relating to use of animal and human subjects, scientific and grant writing, code of ethics for authors, reviewers and editors, and conflict of interest.
Principles of Cancer Drug Therapeutics Development. These required lectures are delivered by CT2 and
UC San Diego faculty members during the fall, spring and winter quarters. These lectures are focused specifically on the necessary sequential steps in drug development.
Topics in Cancer Drug Development. Another series of lectures given by leaders in cancer drug development from
industry. The goal of these lectures are to expose trainees to experts with a substantial track record dealing with the “real life” challenges of cancer drug development. The lecturers are typically the CEO, Director of Research or Medical Director from a company in the San Diego biomedical community, although experts from large pharmaceutical companies have participated actively in this lecture series as well. The outside speakers are invited to discuss the real life challenges they face in the development of a given target or novel therapeutic and thus give the fellows an opportunity to hear the story of the development of specific therapeutic agents.
For the Principles of Cancer Drug Therapeutics Development and Topics in Cancer Drug Development lecture schedules, see the "Lecture Schedule" tab.
In addition to the required lecture series, all CT2 trainees (both PhDs and MDs) have the opportunity to attend several additional seminar programs based at the Moores UC San Diego Cancer Center:
- A weekly seminar “Topics in Hematology-Oncology" in which the faculty and fellows of the Division of Hematology/Oncology present lectures at 7:00 – 8:00 AM on Friday mornings on the clinical use of cancer therapeutic agents and the management of various types of cancer. This is followed by two case presentations (8:00 – 9:00) and then a formal lecture on a research topic by one of the Cancer Center faculty members (9:00 – 10:00).
- A monthly “Cancer Center Director’s Lecture Series” in which national leaders in cancer research from throughout the country are invited to lecture on their research.
It is also expected that trainees will attend research seminars, Tumor Boards and journal clubs specific to their area of specialization. The major biomedical institutions in San Diego (UC Sam Diego, Salk Institute, Sanford-Burnham Institute, and Scripps Research Institute) publish a weekly list of all the seminars scheduled and this averages >25 for any given week between September and June. Many of these deal with cancer therapeutics. Each of the cancer- related clinical services has a weekly Grand Rounds open to CT2 trainees and there are numerous journal clubs that meet on a weekly or bi-monthly basis. There are variety of opportunities to participate in a large number of additional training activities covering an enormously wide range of relevant topics.