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.brown@vanderbilt.edu

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%)