"The Science of Small Clinical Trials," a course created jointly by the FDA's Office of Orphan Products Development (OOPD) and NIH's Office of Rare Diseases Research, (ORDR), deals with issues arising in the design and analysis of clinical trials based on small study populations. While small clinical trials are a necessity in the context of rare diseases, being able to conduct small trials with scientific rigor is of increasing importance in other contexts, particularly as genomic science begins to provide opportunities for individualized pharmacology.
This course provides a broad overview of its subject, and does not require a strong mathematical background. It is not a high-level statistical seminar. The target audience is professionals interested in drug/device evaluation and regulatory affairs.
The first version of the course, offered to FDA/NIH staff in January 2009, has been revised and improved for 2010, with integrated case studies, improved web facilities, and new and returning expert lecturers from within and outside of FDA/NIH. Persons who took last year's course may well want to sign up for the 2010 version, as there will be new content and a revised approach to presenting it.
Attendees will be encouraged to take the self-administered, open-book, confidential web-based online examination at the end of the course, to qualify for a certificate from OOPD.
NOTICE: AS OF MONDAY 15 FEB. 2010, REGISTRATION IS CLOSED.
The onsite venue is the Lister Hill Center Auditorium, Building 38A, National Library of Medicine (NLM), National Institutes of Health (NIH), Bethesda, Maryland, USA (close to Metro's Medical Center station). Onsite participation will be limited to 170.
Live streaming audio/video from the course will be available via the Internet, and viewable on most computing platforms through the use of the freely available RealPlayer software. Questions will be accepted from remote attendees using the course web site's online text-chat room.
Delayed on-demand viewing via the Internet using RealPlayer will also be available. You will be able to view lectures this way within about three business days following the original live lecture, at a time of your own choosing. Questions will be accepted from on-demand viewers using the course web site's discussion forums (which may or may not be answered later at the option and convenience of the instructor).
A dedicated course web site, the Digital Classroom, serves as the focal point for the course (access provided upon registration). Based upon moodle (an open-source course management system used by many universities), it contains EVERYTHING you will need for the course, including: the course schedule; information about the course venue; instructions about how to view the course live and by delayed on-demand video streaming, via the Internet; a calendar system; access to the course textbook; downloadable lecture materials and supplementary resources; discussion forums for each presentation; a live text-chat room; course evaluation questionnaires; and, the self-administered course certification examination. It may also serve in future editions of the course as an organizing mechanism for special class projects.
REGISTRATION IS REQUIRED, FOR BOTH ONSITE AND ONLINE PARTICIPANTS. IF YOU ARE PARTICIPATING ONLINE AS PART OF A GROUP: WE ASK THAT EACH SUCH PARTICIPANT REGISTER INDIVIDUALLY, TO PROVIDE THE STATISTICS WE NEED TO ENSURE CONTINUED SUPPORT FOR THIS ACTIVITY.
NOTICE: AS OF MONDAY 15 FEB. 2010, REGISTRATION IS CLOSED. 1300 STUDENTS WERE ENROLLED. THANKS FOR YOUR INTEREST; PLEASE LOOK FOR US AGAIN NEXT YEAR.
The course is FREE and open to anyone. If you are interested in participating, please make room for this event in your calendar (see schedule below), and use the online registration system (see link below).
Please note that this is a course, not a series of independent lectures; enrollees will be expected to make a serious effort to attend/view all lectures, and are encouraged to take the final certification examination (which allows at most one lecture to be missed). Certificates are presented ONLY to those passing the exam; simply attending the course does not qualify you for certification.
Regrettably, we are not able to provide any continuing education credits for this year's edition of the course, but we anticipate being able to do so next year.
The following schedule is subject to change. The course will comprise seven two-hour lectures, running from 10 AM to noon, Eastern US time zone (interrupted midway by a brief break). Short case studies will be integrated into the end of each presentation, followed by a group discussion and Q&A period led by the main presenter.
If you have further questions, or problems registering, contact the
The Science of Small Clinical Trials (small-trials.keenminds.org) / January 2010