"An Introduction to Clinical and Translational Research"
Introduction to Clinical and Translational Research-From Bench to Bedside Time: 9:00-9:50 am Location: 419 B-D Light Hall* Course director: Mark deCaestecker Mark.de.caestecker@Vanderbilt.Edu Co-director: Abigail Brown Abigail.email@example.com Course Website: Visit our website for more details, lectures, links to journals etc… https://medschool.vanderbilt.edu/cpmm/course Syllabus: Day Date Topic Speaker Friday 10-Feb Course Overview deCaestecker Monday 13-Feb Overview of Translational & Clinical Research deCaestecker Wednesday 15-Feb From the bench to T1/T2 research Doug Sawyer Friday 17-Feb Discussion: Topical Issues in Translational deCaestecker* Research (meet in 415 B-D LH today only) Monday 20-Feb Introduction to atherosclerosis & Biomarkers of Sergio Fazio Human Disease Wednesday 22-Feb Animal models of atherosclerosis Amy Major Friday 24-Feb Journal Article Discussion deCaestecker & Brown Monday 27-Feb Human Clinical Trials Yu Shyr Wednesday 29-Feb Biorepositories, Electronic Medical Records, & Russ Wilke Use of Human Samples in Research Friday 2-Mar Drug Development & Regulation Satish Raj Monday 5-Mar Journal Article Discussion deCaestecker & Brown Wednesday 7-Mar Device Development & Regulation Jeff Rottman Friday 9-Mar Human Subjects Research Matt Luther Monday 12-Mar Journal Article Discussion deCaestecker & Brown Wednesday 14-Mar IRB & Ethical considerations in human subjects Todd Rice research Friday 16-Mar Discussion: Ethics of Human Subjects Research Larry Churchill Journals, discussion groups and reports Five of the classes will be dedicated to the student-led journal clubs and discussion groups. For the journals, one paper relevant to the topics of that week will be chosen by the course organizers along with an accompanying editorial or review. All students except those presenting the paper each week will be expected to hand in a report on the journal at the end of that class which will be graded according to the criteria outlined below. For the discussion groups without journal presentations you will also be given some preparatory literature to read and will need to write a brief report, as outlined below. 1. Journal article presentations (Feb 24th, March 5th and 9th) The class will be divided into 3 groups, each of which will work together to prepare one of the papers for the journal club weeks. Each student will participate in preparing and presenting the paper. The presentation should last no more than 30 minutes. Since the time allocated is relatively short, we will select reasonably short and succinct papers. However it will also be incumbent on the students to focus on the most important aspects of the paper rather than go over every last detail. You will not be graded on the quality of your presentations. However each student will be given personal feedback by the organizers at the end of the Friday class. After the presentation, the class will be split into two discussion groups with journal presenters evenly distributed between the two groups to lead discussion for the group and help answer questions. Mark and Abby will help moderate each of the groups and make sure there is even discussion involving all of the students. Each of you will be graded for your participation during discussion of the paper. Along with the other discussion groups (see below), this will represent 50% of your grade based on your involvement in the discussion, understanding of and insights into the paper. Journal Articles: th Feb. 24 : Inhibition of miR-33a/b in non-human primates raises plasma HDL and lowers VLDL triglycerides. Rayner KJ, Esau CC, Hussain FN, McDaniel AL, Marshall SM, van Gils JM, Ray TD, Sheedy FJ, Goedeke L, Liu X, Khatsenko OG, Kaimal V, Lees CJ, Fernandez-Hernando C, Fisher EA, Temel RE, Moore KJ. Nature. 2011 Oct 19; 478(7369):404-7. March 5th: o Construction of atorvastatin dose-response relationships using data from a large population-based DNA biobank. Peissig P, Sirohi E, Berg RL, Brown-Switzer C, Ghebranious N, McCarty CA, Wilke RA. Basic Clin Pharmacol Toxicol. 2007 Apr;100(4):286-8 o Characterization of low-density lipoprotein cholesterol-lowering efficacy for atorvastatin in a population-based DNA biorepository. Wilke RA, Berg RL, Linneman JG, Zhao C, McCarty CA, Krauss RM. Basic Clin Pharmacol Toxicol. 2008 Oct; 103(4):354-9. March 12th: Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. Taylor AL, Ziesche S, Yancy C, Carson P, D'Agostino R Jr, Ferdinand K, Taylor M, Adams K, Sabolinski M, Worcel M, Cohn JN; African-American Heart Failure Trial Investigators. N Engl J Med. 2004 Nov 11; 351(20):2049-57. 2. Other discussion groups (Feb 17th and March 16th) Two of the sessions will be moderated discussion groups covering general issues (Feb 17 th with Mark and Abby), and ethical issues with examples (March 16 th with Larry Churchill, Chairman of Medical Ethics at Vanderbilt). It is important that you prepare for these by reading the literature we will give you in advance and by writing your reports (that is why we are asking you to do these things!). You will be expected to participate in the discussions, and Abby and Mark will be trying to encourage everyone to participate as best we can. As per above, each of you will be graded for your participation during discussion of the paper. Along with the other journal discussion groups (see above), this will represent 50% of your grade based on your involvement in the discussion, understanding of and insights into the paper. 3. Journal and discussion group reports Two different kinds of reports have to be generated at five of the classes: a. Journal club reports (Feb 24th, March 5th and 9th). Students will write a brief report on the journal article to be handed in at the end of the class (~1 page per paper). The student speakers for the week will be excused from this. Each paper summary should contain: a) a brief summary; b) comments about the single most important piece of data (figure or table); c) major criticisms; d) ideas generated by reading the paper and how the findings impact human health and disease. Reports will be graded by Mark and Abby and written feedback will be given on these reports each week. b. Other discussion group reports (Feb 17th and March 16th). For both sessions you will be expected to read some relevant literature that we will give you and which will be used as part of the discussion. You will need to write a one page report about this which is different from the journal reports and hand it in at the end of class. For this you will outlining key elements of these reviews/commentaries along with some ideas that they provoke with you for discussion (this part is the most important). Journal and discussion reports represent 50% of your grade. For the journal reports, 50% of the grade will be given to you if you simply sticking to the written guidelines above. For the other discussion group commentaries you will be given 100% of your grade if you hand something in with a decent amount of writing on it! However, if you do not hand either the journal club or discussion group reports at the end of class and have not emailed or spoken to Abby or Mark, you will be given zero for these assignments. Grading 1) Weekly journal or discussion group report (50%) 2) Participation (50%)