Principals of Biomedical Research

Guri Tzivion, PhDtzivion@windsor.edu

Extension 506

PBMR 611: Winter 2016Windsor University School of Medicine

PBMR 611 MDII: Principals of Biomedical Research

Class 2

Introduction to Biomedical Research2. Biomedical research types: basic, clinical

and epidemiological research

Biomedical Sciences

Biomedical sciences are a set of applied

sciences, applying portions of natural science

or formal science, or both, to developing

knowledge, interventions, or technologies of

use in healthcare or in public health

Biomedical Research

Biomedical research, or experimental

medicine, includes basic, applied, translational

and clinical research aimed at developing and

enhancing our knowledge in the field of

medicine

Biomedical Research

Biomedical research types:

• Basic and Preclinical Research

• Clinical Research and Applied or

Translational Research

Basic Biomedical Research

Basic biomedical research is defined as research that tackles the most fundamental areas of medical research including, but not limited to:

•Cellular and Molecular Biology

•Medical Genetics

•Immunology

•Medical Biochemistry

•Physiology

Basic Biomedical Research

Aims to establish an understanding of the cellular, molecular and physiological mechanisms underpinning human health and disease.

Since many organisms share a common evolutionary history with humans and hence common features and systems, the basic end of medical research shades into basic biology and vice versa.

Basic Biomedical Research: Preclinical Research

Pre-clinical research covers research that prepares the ground for clinical research with patients. Typically the work requires no ethical approval (though some work with animals does), is supervised by people with PhDs rather than medical doctors, and is carried out in a university or company rather than a hospital.

It includes also the preclinical phase of drug testing.

Clinical Research

Clinical research is carried out with patients. It is generally supervised by doctors in a medical setting such as a hospital and requires ethical approval and IRB (Institutional Review Board).

The clinical phase of drug testing is covered by Clinical Trials.

Clinical Research Clinical studies include the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings.

The goal of a clinical study is to assess the safety, efficacy, and/or the mechanism of action of an investigational medicinal product, or new drug or device that is in development, but not yet approved by a health authority (e.g. FDA).

Clinical Research

Outline of types of designs for clinical studies:

• Treatment studies: randomized controlled

trials: includes blinded and non-blinded

trials.

• Observational studies: includes prospective

and retrospective cohort studies

• Epidemiological studies

Journal Club1st theme: longevity research and sirtuin activators

1. Howitz KT, et al. Small molecule activators of sirtuins extend Saccharomyces cerevisiae lifespan. Nature. 2003 Sep 11;425(6954):191-6.

2. Baur JA, et al. Resveratrol improves health and survival of mice on a high-calorie diet. Nature. 2006 Nov 16;444(7117):337-42.

3. Hubbard BP and Sinclair DA. Small molecule SIRT1 activators for the treatment of aging and age-related diseases. Trends Pharmacol Sci. 2014 Mar;35(3):146-54.

Journal Club1st theme: longevity research and sirtuin activators

1. Howitz KT, et al. Small molecule activators of sirtuins extend Saccharomyces cerevisiae lifespan. Nature. 2003 Sep 11;425(6954):191-6.

2. Baur JA, et al. Resveratrol improves health and survival of mice on a high-calorie diet. Nature. 2006 Nov 16;444(7117):337-42.

3. Hubbard BP and Sinclair DA. Small molecule SIRT1 activators for the treatment of aging and age-related diseases. Trends Pharmacol Sci. 2014 Mar;35(3):146-54.

Journal Club2nd theme: B-Raf mutations and their targeting in Melanoma

4. Davies H, et al. Mutations of the BRAF gene in human cancer. Nature. 2002 Jun 27;417(6892):949-54.

5. Tsai J, et al. Discovery of a selective inhibitor of oncogenic B-Raf kinase with potent antimelanoma activity. Proc Natl Acad Sci U S A. 2008 Feb 26;105(8):3041-6.

6. Bollag G, et al. Clinical efficacy of a RAF inhibitor needs broad target blockade in BRAF-mutant melanoma. Nature. 2010 Sep 30;467(7315):596-9.

7. Sosman JA et al. Survival in BRAF V600–Mutant Advanced Melanoma Treated with Vemurafenib. N Engl J Med 2012; 366:707-714.

Full text link: http://www.nejm.org/doi/full/10.1056/NEJMoa1112302

Journal Club3rd theme: Diabetes and high cholesterol management

8. Knowler WC, et al. "Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin". The New England Journal of Medicine. 2002. 346(6):393-403

Full text link: http://www.nejm.org/doi/full/10.1056/NEJMoa012512

9. Patel A, et al. "Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes". The New England Journal of Medicine. 2008. 358(24):2560-2572.

Full text link: http://www.nejm.org/doi/full/10.1056/NEJMoa0802987

10. Kastelein JJ, et al. "Simvastatin with or without ezetimibe in familial hypercholesterolemia". The New England Journal of Medicine. 2008. 358(14):1431-1443.

Full text link: http://www.nejm.org/doi/full/10.1056/NEJMoa0800742

Course Description

Journal Club:• 10 research papers will be assigned, covering all

aspects of biomedical research, including basic,

clinical and epidemiological research

• Each student will present one paper

• All students are required to read the weekly papers

and are expected to actively participate in group

discussions

Journal ClubPresentation format:

• Introduction to the subject area: General review of the subject What was known before the authors started

their work • The declared hypothesis and objectives of the study• Methodologies used in the study• Results:

Present the actual results of the study Discuss each of the figures in detail

Journal Club

Presentation format: • Discuss the significance of the study and its

contributions to advancing the subject area/field (as

presented by the authors)

• Your critical analysis of the study:

Strengths and weaknesses

If you were the reviewer of the paper, what

would be your critique?

Journal Club

Other points to consider in preparing your presentation:

• Have a simple title for each slide

• Fonts should be large enough to be seen clearly

from the back of the room

• Figures: for multi-panel figures, enlarge and show

each panel separately

Journal ClubPresentation skills:

• Be familiar with the presentation content

• Speak loudly and clear

• Speak with excitement, don’t be monotone

• Do not read the slides – use the text as reference

• Face the audience, make eye contacts

• Use body language (facial expression, gesture)

• Do not abuse the pointer

Journal ClubPresentation evaluation grid:

• Familiarity with the subject (20%):

• Presentation skills (20%):

• Stimulation of group discussion (20%):

• Preparedness (20):

• Overall presentation quality (20):

• Final evaluation:

• Comments for the student:

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