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General Information

Course Title:
Clinical Trials Overview: Methodology and Practice (GSND-N5310-001)

Location:
Thursdays, 5:30 8:30 PM, January 10 to April 24.
Medical Sciences Building (MSB) B540A & B540B.

Instructor:
David L. Hom, MS
Assistant Professor
Department of Primary Care
School of Health Related Professions - UMDNJ
Assistant Professor of Medicine
Center for Emerging Pathogens/Division of Infectious Diseases
ADMC Bldg 6, Suite 614
New Jersey Medical School - UMDNJ
973.972.8699; homdl@umdnj.edu

Guest Lecturers:
Carlotta Rodriguez, BS, CIP
Director, Newark Campus Institutional Review Board
University of Medicine & Dentistry of New Jersey.

Norman Lasser, M.D., Ph.D.
Professor of Medicine/Director, Preventive Cardiology Program,
Department of Medicine – NJMS.

Carolyn Rogers, BSN, RN, CCRC
Research Nurse – Department of Neurosurgery, NJMS.

Course Description:
This course is designed to teach researchers at all levels (investigator, study coordinator, study monitor, study staff) the fundamentals of a good clinical trial in the evaluation of a new drug or device, be it industry, federal or philanthropic sponsored. Whether the ultimate purpose is to create a clinical protocol, or to carry out or monitor a protocol, understanding the options and reasons for a clinical trial design impacts the daily conduct and success of the trial. Discussion starts with the evaluation process leading up to human volunteer trials, through elements in designing a trial, writing the scientific protocol, considering regulatory issues and human subjects protection, through elements in protocol development/implementation, and quality assurance.

Class Format:
Initial sessions are didactic presentation. After midterm – half didactic and half journal club presentation. Journal Club - Students will group into pairs, critique a published phase I through III clinical trial, design, objectives, results, etc, and be graded by fellow classmates on presentation and command of topic.

Course Credits:
3 Credits

Evaluation:
Midterm Exam (30%) – closed book, timed-duration, short-paragraph response.
Final Exam (40%) – closed book, timed-duration, semester cumulative, short-paragraph response.
Journal Club Presentation (20%) – See above.
Class participation (10%) – at discretion of instructor – based on class attendance and active class participation.

Texts:

	Clinical Research: What It Is and How It Works. LA Nesbitt, Jones & Bartlett: Boston, 2004. ISBN 0-7637-3136-6. Small handbook that discusses in-depth the operational aspects of conducting clinical trials (e.g. institutional review boards, human subjects protection, clinical research industry, trial implementation, data management, quality management and FDA readiness, business of clinical research, clinic Selected chapters listed in syllabus under the appropriate session. Available for purchase from Jones & Bartlett Publishers (www.jbpub.com) or www.borders.com.
	Fundamentals of Clinical Research. 3rd edition LM Friedman, CD Furberg, DL DeMets, Springer-Verlag: New York, 1998. ISBN 0-387-98586-7. Text that discusses in-depth the fundamental design, analysis and reporting of clinical trials (e.g. hypothesis, study population issues, basic study designs, randomization, blindness, sample size, recruitment and assessment of study participants, data collection and quality control, assessing and reporting adverse effects, adherence, issues of data analysis, closeout and repo Selected chapters listed in syllabus under the appropriate session. Available for purchase from Springer-Verlag Publishers (www.springer.com) or www.borders.com
	The Future of Drug Safety: Promoting and Protecting the Health of the Public. Institute of Medicine, National Academies Press: Wash DC, 2006. ISBN 978-0-309-10304-6. This book represents an FDA request for the National Academies of Science’s Institute of Medicine (IOM) to convene an ad hoc committee of experts to conduct an independent assessment of the current system of evaluating and ensuring drug safety. This 2006 report comes on the heels of several high profile drug recalls and Congressional hearings with patient groups asking for greater oversight. The National Academies Press (http://www.nap.edu/)
	Challenges for the FDA: The Future of Drug Safety, Workshop Summary. Institute of Medicine. National Academies Press: Wash DC, 2007. ISBN 0-309-10987-6. The National Academies Press (http://www.nap.edu/)

Students are encouraged to use other sources for review and for assignments. The texts below serve as supplemental texts to what is covered in each session. You should consult additional articles, websites, etc. The Internet and the UMDNJ library resources (full text articles) represent a rich updated source of information, though you should keep in mind the validity of the information based on the source.

Other Recommended Texts:

A Step-by-Step Guide to Clinical Trials.
M Mulay, Jones & Bartlett: Boston, 2001. ISBN 0-7637-1569-7.

The Investigator’s Guide to Clinical Research. 3rd edition
D Ginsberg, Thompson CenterWatch: Boston, 2002. ISBN 1-930624-30-1.

Basic & Clinical Biostatistics. 3rd edition
B Dawson, RG Trapp. McGraw-Hill: New York, 2001. ISBN 0-8385-0510-4

Clinical Trials: Design, Conduct and Analysis.
Meinert Cl. Oxford Press: Oxford, 1986. ISBN 0-19-503568-2.

Design and Analysis of Clinical Trials: Concepts and Methodologies. 2nd edition. SC Chow, JP Liu. 2004. Wiley & Sons: Hoboken, NJ. ISBN 0-471-24985-8.

Pharmacoepidemiology. 2nd edition
BL Strom. 1995. Wiley & Sons: Hoboken, NJ. ISBN 0-471-94058-5.