Clinical Research Workshop: How to perform clinical research in your practice.
Course Presenters: Robin Chalmers, Barbara Caffery, Sue Cotter, Karla Zadnik,
Harue Marsden, Greg Nixon, Ron Watanabe, Wendy Harrison
This workshop will provide a forum for you to understand the importance and the
mechanics of performing optometric clinical research. You will be asked to
participate by bringing a clinical question and joining a breakout group to
formulate a hypothesis and create a protocol. There will be lectures and breakout
sessions.
The course will begin with an Introduction that will explain the Academy’s new
initiative for the funding of clinical research. The various types of clinical research,
from case series to full blown clinical trials, will be described. The important
lessons learned from clinical studies that inform your practice every day will be
reviewed.
The Ethics of clinical research will be presented. The importance of such issues
as informed consent, rigorous methodology, fair subject selection, risk to benefit
and privacy will be discussed.
A review of team formations and multi-centered studies will be presented.
The clinical questions that you have brought to the workshop will be reviewed
and the methods of creating hypotheses from these questions will be taught
through breakout sessions and discussion.
Clinicians who have performed clinical research in their practices will inform you
as to how this is best accomplished within the daily routine of clinical care.
Finally, a question and answer period will close out the workshop.
1
Plan: Clinical Research Workshop
Workshop will last 100 minutes (50 minutes per hour designated)
I. (30 Minutes): Welcome: Barbara Caffery
Introduction:
1. The Academy’s new initiative to fund clinical research- Barbara Caffery
2. Clinical research that is ongoing in Optometry: myopia, PEDIG- Sue Cotter
3. Clinical Studies that have changed optometric practice: OHTS, AREDSGreg Nixon
II. (20 minutes) Ethics- Karla Zadnik
Ethics in biomedical research surrounds everything we do. Our ethics mandate
that we conduct our human subjects research governed by the principles of
respect for persons, beneficence/non-malfeasance, and justice. From the
travesties of the Tuskegee Study to today’s headlines, advancements in patientoriented research must be dictated by appropriate interactions with our research
participants, including approvals for retrospective chart reviews, an appropriate
informed consent process, and sensitivity to the vulnerable populations we study.
III. (15 minutes) Team Formation and Multi-Center Trials: Robin Chalmers
The creation of research teams is a critical aspect of successful observational
research. Common goals, adherence to protocols, getting the job done, reporting
and interacting are a few of the many important variables in such research.
IV. Clinical Questions and How to Get Started:
The clinical questions that you have created will be brought forward. Five of
these will be chosen and teams will break out into interested teams to create
hypotheses and protocols.
V. How to make your Clinic a research Centre: Ron Watanabe
2
How a clinician integrates research into her daily practice is a complex and
exciting project. Learn the pitfalls and pleasures of the process from clinicians
who have accomplished this task.
VI. Reporting and Q and A:
The panel will be available to hear the reports of each break out group and to
answer any questions about research in clinical practice.
3