ICCR – Intensive Course in Clinical Research: Study Design & Performance
Spectrum serves faculty and clinical research personnel at Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital, and the Veterans Affairs Palo Alto Health Care System.
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The Spectrum Intensive Course in Clinical Research (ICCR) is a one-week immersion course designed for new clinical investigators, senior residents, fellows, and junior faculty interested in pursuing careers in clinical and translational research.
Students spend five days and four late evenings immersed in all aspects of research study design and performance. The format combines didactics with intense group/team activities focused on practical issues in clinical research design—from selection of a researchable study question through actual writing of a research proposal. Lectures and panel discussions are presented by an accomplished faculty of Stanford clinical researchers and key leaders from the Stanford community. Every presentation includes a discussion of relevant issues.
Sponsored by the Spectrum Programs: Career Diversity and Development Center; Center for Innovative Study Design; Child Health; Operations, Training and Compliance; and Research Education and Training.
Click on any of the headings below for detailed information.
Clinical research is heavily regulated and potential clinical investigators require education on all the requirements of good clinical practice. After review of FDA Rule on Protection of Human Subjects: Informed Consent and Federal Register Guidance on General Considerations for Clinical Trials and discussion with Stanford faculty, it was determined that potential clinical investigators at Stanford would benefit from immersive education on clinical research issues.
The course is designed to meet the educational needs of the target audience including clinical research design, available statistical and data management resources at Stanford, ethics and informed consent, data collection, publishing of clinical research findings, and clinical research monitoring at Stanford, and build a foundation of clinical research amongst junior faculty and fellows.
After completing the course, the student will be able to:
- understand the different types of designs for clinical research and their advantages and disadvantages for addressing different clinical issues.
- conceptualize a clinical decision problem as a researchable question and choose an appropriate design.
- efficiently use resources such as statistical and data management consultation to appropriately size the study.
- understand and be able to choose among the various kinds of endpoints and analyses.
- anticipate and address ethical issues that may arise as a result of the study design and elicit valid informed consent.
- plan the collection of data, assure its quality, and summarize and describe the research in a publishable form.
This course is designed for new or potential Stanford investigators at the senior resident, fellow or junior faculty (Assistant Professor and below from any faculty line) who have not had formal training in clinical research as part of a Masters or PhD degree program in Public Health or Epidemiology.
There is no cost to students or Departments for this course. However, to be effective, this must be an immersion experience for students who must each bring a personal commitment to focus on the course for a full week away from all other clinical and other work-related activities. Students are required to be relieved of all clinical and other work-related responsibilities for the duration of the course.
The department chair/division chief/fellowship directors select and nominate intended course participants through a nomination form whereby releasing nominees from all clinical and work-related duties during the course week. Two courses are held each year (one focused on adult health research and one focused on child health research).
Course Dates: Sept. 12 - 16, 2016
- Conceiving the Research Question
- Hair-Color Products and Risk for Non-Hodgkin's Lymphoma: A Population-Based Study in the San Francisco Bay Area
- The Belmont Report
- Human Subjects Research Regulations
- Using Direct Mail
- Innovative Techniques to Address Retention
- Recruitment and Retention of Healthy Minority Women
- Reporting the Recruitment Process in Clinical Trials
- Minority recruitment into clinical trials (Summary)
- Surrogate Endpoints in Clinical Trials
- Introduction to Medical Statistics
- Biostatistics, The Bare Essentials
- Practical Statistics for Medical Research
- Theoretical Distributions
- Analysis of Randomized Controlled Trials
- Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
- Bioethics Consultation
- Clinical and Translational Science Awards and Community Engagement
- The Meaning of Translational Research and Why It Matters
- Clinical Research Methods: The Basics
- Clinical Research Methods: From the Clinical Perspective
- Meeting the Challenges of Recruitment and Retention
- Finding, Informing, and Studying Research Volunteers
- The Ethics of Clinical Research
- Cultural Effectiveness in Clinical and Translational Research
- Clinical Trials from the Statistical Perspective
- Clinical Trials from the Clinical Perspective
- Observational Studies
- Regulatory Issues in Clinical Research: The Responsible Investigator
- Statistical Inference, Sample Size Determination and Statistical Power
- Data Management and Display
- Using STRIDE as a Research Tool
- Critical Appraisal of Published Studies
- Stanford Resources:
— Lane Medical Library
— Spectrum- Study Navigator
— Spectrum Child Health
— Spectrum Community Health
— Spectrum Innovations and Pilots
— Finding Funding
- Comparative Effectiveness in Research Methodology
- Critical Appraisal of Research Methodology
- Grant Writing
- How to Get a Mentored Career Development (“K”) Award
- Life-Work Balance
- September 8-12, 2014
- September 9-13, 2013 | March 25-29, 2013
- September 10-14, 2012 | March 26-30, 2012
- September 12-16, 2011 | March 21-25, 2011
- September 13-17, 2010 | March 23-27, 2010
Mentors are the core of each Intensive Course in Clinical Research. Mentors spend approximately 40 hours reviewing projects, communicating with ICCR students, advising on projects and providing career advice before, during and after the course. Graduates from the prior years courses return as mentors to truly absorb the course content and network with their peers.
“The skills, knowledge, and mentorship are incredibly invaluable in this course and I cannot quantify how much knowledge I have gained from this intensive week. I reviewed literature that I had read prior to coming to this course regarding my proposal and then re-read the same literature pieces prior to our presentation and my ability to understand the statistical considerations, methods, and even the background and discussion were so much more enhanced just by this week. From that simple measure alone, I realize how valuable the teaching and course was in that regard but cannot begin to imagine how helpful this course has been in the grand scheme of my career as a provider and a researcher as well as in policy and advocacy. Simply an excellent course! It was well organized, thorough in concepts of clinical research methods and assessment, and provided a very integral, personalized piece of mentorship and guidance. The teachings from other mentees in the group were also a very valuable piece of this amazing course. I am so grateful that I was a part and see the teachings as a foundation that will continue to be built upon throughout my career. Thank you for the opportunity for an intangible educational experience.” — Medical Fellow, ICCR March 2011
"Last fall I had the opportunity to participate in the ICCR course offered by CHRP/HRP and SPCTRM. The course is unique in the medical school and offers much needed training in the conduct of clinical research as well as the opportunity to meet and interact with multiple potential mentors. I have been here at Stanford for a number of years, and often experienced clinical research as an arduous task due to the difficulty in identifying individuals to help bridge knowledge and experience gaps. ICCR aims to help provide that bridge, by pointing out potential pitfalls in the conduct of clinical research, and by identifying go-to people for those inevitable quagmires, with lectures in clinical research methods, biostatistics, interventions and endpoints, and others. Most helpful for me was the process of working on one proposal in detail over the five day course and shaping it into a tight, realistic study. Thanks for the opportunity to participate in this valuable course, and I look forward to joining the group again as an assistant tutor." — MD, ICCR 2007 Graduate
"ICCR has proved to be an invaluable part of my research training at Stanford. Not only were we exposed to senior faculty with extensive experience and success in research, but also to truly remarkable colleagues doing important research in child health. The retreat like setting (and food!) provided a rare, clinical-responsibility-free opportunity to really focus on research methods and develop a research project. The collaborative, team approach also helped set the stage for some possible future collaborations. Thank you again for the opportunity to be a part of it!" — Fellow, ICCR 2006 Graduate
“My goals for taking this course were achieved on several accounts. 1) I was hoping to get a better understanding of the oversight and resources on campus for medical research. 2) I gained better clarity regarding my own specific project by learning about project design and factors that must be taken into account when putting a project together. 3) I made connections with people outside of my own field and was able to use their input to expand upon ideas for my current and future projects.” — Fellow, ICCR September 2010 Graduate
“I certainly learned much more detail regarding designing a clinical study and have a greater understanding of the difficulties and common pitfalls. Completion of this course has assisted me greatly in designing the next phase of my research.” — MD/DO, ICCR September 2010 Graduate
“I achieved more than what I planned and expected. It was an eye opening moment and I am very glad I took this course earlier in my career. I think I am a lot more advanced than my colleagues.” — Resident, ICCR March 2010 Graduate
“I learned how to refine my research question. I also defined my aims and hypothesis. I gained advice on statistical methods for the study. Thank you very much for organizing this program.” — Resident, ICCR September 2009 Graduate
- ICCR explores career advancement, time management, and challenges of clinical trials research; discussion of individual projects and opportunities for collaboration with peers and mentors.
- ICCR inspires networking across departments with an extended network of colleagues, and provide resources to achieve successful clinical and translational research projects.
- To attend ICCR the Stanford resident, fellow or junior faculty must be nominated by the Division Chief or Department Chair and be released from all clinical and work-related duties during the course week.