Essentials of Clinical Research: Developing a Clinical Protocol

January 10, 2018 @ 3:30 pm – 6:00 pm
Alway Building, M112
291 Campus Drive
Stanford, CA 94305
Kiera Larsen
Essentials of Clinical Research: Developing a Clinical Protocol @ Alway Building, M112 | Stanford | California | United States

Presenter: Mark Pegram, MD
Professor of Oncology
HRP273 Essentials of Clinical Research at Stanford, Winter Quarter 2018

We are excited to announce that the second annual “Essentials of Clinical Research at Stanford” Winter Quarter starts tomorrow! This course, broken into 4 modules, provides a step-by-step model for the design and conduct of clinical research at Stanford. Upon course completion, attendees will have an introduction on how to:

  1. design and analyze clinical studies and prepare protocols,
  2. comply with Good Clinical Practice guidelines for study conduct, data management, and relevant regulations,
  3. understand principles and practices underlying ethical and reproducible research, and
  4. deal with special issues that arise in cancer, pediatric, mental health, surgical, cardiovascular and community health research.

This course is a collaborative effort with Spectrum and the Health Research and Policy department.  Module 2 classes of the Winter Quarter (as well as Modules 3 and 4) are listed below for your reference. Please join us by clicking here to register and please let us know if you have any questions!

Module 2: Conduct of Research
Day Date Room # Topic Details Speaker
Wed 10-Jan M112 Developing a Clinical Protocol Scientific merit, IND/IDE requirements, clinical research objectives, clinical study design Mark Pegram, MD
Thurs 18-Jan LK130 Running a Clinical Trial Study Set-up, regulatory review, budget and contract, study team, GCP, delegation of authority, informed consent, essential documents and documentation Peg Tsao, RN, Kiera Larsen, RN & Maya Berdichesky, DMD
Thurs 25-Jan LK130 Trial Closeout Evidence based operations, end of study planning, statistical analyses, trial committees, DSMB, reporting, data sharing/open source Ken Mahaffey, MD
Module 3: Ethics and Reproducibility
Day Date Room # Topic Details Speaker
Thurs 1-Feb LK130 Ethics and Clinical Research Responsible conduct of research and misconduct, rules of science, informed consent Holly Tabor, PhD
Thurs 8-Feb LK130 Research Reproducibility Statistical analysis tool and data science Steven Goodman, MD and Tom Hardwicke, PhD
Module 4: Specialty Topics
Day Date Room # Topic Details Speaker
Thurs 15-Feb LK130 Research Issues in Surgery Arden Morris, MD
Thurs 22-Feb LK130 Research Issues in Cancer Clinical trial and regulatory processes for anticancer drug development, early phase trial design, evolving designs for targeted agents and regulatory framework for drug development Shivaani Kummar, MD, Nam Bui, MD and Nora Ku
Thurs 1-Mar LK120 TBD: Pediatrics or Cardiovascular Medicine TBD
Thurs 8-Mar LK120 Research Issues in Community Engagement Rhonda McClinton-Brown and Lisa Goldman Rosas
Thurs 15-Mar G1002 TBD: Pediatrics or Cardiovascular Medicine TBD
Thurs 22-Mar G1002 Research Issues in Psychiatry Ruth O’Hara, PhD