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Adaptive Enrichment Designs for Confirmatory Randomized Trials: Statistical Methods and Software Tools
Title: Adaptive Enrichment Designs for Confirmatory Randomized Trials: Statistical Methods and Software Tools Instructor: Michael Rosenblum, PhD Associate Professor of Biostatistics Johns Hopkins Bloomberg School of Public Health https://mrosenblumbiostat.wordpress.com/ mrosen@jhu.edu Background: Most randomized trials are designed to determine average treatment effects for a population. This results in trials that may fail to detect important differences in benefits and harms for subpopulations. For example, standard trial designs are not targeted to determine whether a treatment benefits most patients, benefits only a select few, or benefits some patients and harms others. The impact is that treatment recommendations based on the results of…
Find out more »Pharmaceutical Enterprise Course (ME:208.708)
This course begins Sept 1st. Contact Takashi Tsukamoto for more information. Pharmaceutical Enterprise” is a discussion-driven and highly interactive course designed to provide students with greater insights into a range of topics related to the pharmaceutical enterprise. The course consists of seven modules, each of which begins with a pre-lecture discussion session proceeded by a lecture by an expert in the given subject, and post-lecture discussion session. This 3-segment format enables students to digest the topic thoroughly and gain in-depth knowledge through peer discussion and interaction with lecturers. The course is particularly suited for individuals interested to advance their career…
Find out more »Good Clinical Practice and Investigator Responsibilities in Human Subjects Research
The session will focus on the principles of Good Clinical Practice (GCP) and how they apply practically in the day-to-day operation, management, and conduct of Human Subjects Research. The session will further discuss means to develop and implement basic oversight capabilities to maximize quality data, regulatory compliance, and human subject safety. This workshop will count as in-person credit for PI HSR recertification. To register, visit http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=587495
Find out more »Single IRB Sessions
As of January 2018*, all competing National Institutes of Health (NIH) grant applications for multi-site research require a plan for use of a single IRB. This training will review NIH's new policy for single IRB review and its implications; discuss how JHU will address the single IRB review requirement; provide advice on how to continue to provide a safe, ethical research environment while participating in single IRB studies and offer practical tips for grant applications, including budget development. Investigators and study team members preparing grant applications subject to these new requirements are encouraged to attend. Download the Flyer Please Register Via the Link Below:…
Find out more »Single IRB Sessions
As of January 2018*, all competing National Institutes of Health (NIH) grant applications for multi-site research require a plan for use of a single IRB. This training will review NIH's new policy for single IRB review and its implications; discuss how JHU will address the single IRB review requirement; provide advice on how to continue to provide a safe, ethical research environment while participating in single IRB studies and offer practical tips for grant applications, including budget development. Investigators and study team members preparing grant applications subject to these new requirements are encouraged to attend. Download the Flyer Please Register Via the Link Below:…
Find out more »Third Thursdays with the ICTR
The Institute for Clinical and Translational Research is continuing its new lecture series, “Third Thursdays with the ICTR.” Each month, speakers will share research-related news and showcase a resource and/or service that can aid clinical research study team members. The next lecture is Thursday, September 21 from 1 p.m. – 2 p.m. in The Wood Basic Science Building West Lecture Hall. This month’s speaker Holly Taylor, PhD, Associate Professor of Health Policy & Management with Johns Hopkins Bloomberg School of Public Health. Her presentation, “ICTR Research Ethics Consultation Service" will elaborate on the goals of the Research Ethics Consultation Service,…
Find out more »CRMS Monthly Training Course
Demo of CRMS, discuss common mistakes and answer questions. 12:00-1:00 pm This one hour session will guide you through the use of CRMS. The instructor will give a demonstration of CRMS, discuss common mistakes made, and answer questions. If you are required to use CRMS because your study has a Prospective Reimbursement Analysis (PRA), we strongly urge you to attend this training session. It is a great chance to ask questions about CRMS in an informal setting. Participation in this course is recommended for those that have not already taken the Friday CRO course on CRMS. Click here to register…
Find out more »2017 Henrietta Lacks Memorial Lecture
*Register Here* The Johns Hopkins Institute for Clinical and Translational Research (ICTR) invites you to attend the Henrietta Lacks Memorial Lecture on Saturday, October 7, 2017, from 9:00 am to 12:30 pm in Turner Auditorium on the Johns Hopkins East Baltimore (Medical) Campus. Continental breakfast and check-in begin at 8:00 am. The keynote speaker is Lisa A. Cooper, MD, MPH, FACP, the director of the Johns Hopkins Center for Health Equity, a Bloomberg Distinguished Professor, and a James F. Fries Professor of Medicine at the Johns Hopkins University School of Medicine and the Johns Hopkins Bloomberg School of Public Health. She will discuss…
Find out more »Third Thursdays with the ICTR
The Institute for Clinical and Translational Research is debuting a new lecture series, “Third Thursdays with the ICTR”. Each month, speakers will share research related news and showcase a resource and/or service that can aid clinical research study team members.
Find out more »