Wksp Clinical Research Jan-Feb 2011, Kolkatta

[Guest guest]

Clinical Pharmacology Section, Indian Pharmacological Society

ANNOUNCES

National Workshop

Basics of Clinical Research Methods

Jan 31 - Feb 05, 2011

Venue : Lecture Hall, All India Institute of Hygiene & Public Health, Kolkata

Organized in Collaboration with:

All India Institute of Hygiene & Public Health, Kolkata

Calcutta School of Tropical Medicine, Kolkata

Workshop Philosophy:

This workshop will provide an overview of various elements of clinical research

methods. Some topics will be presented in great details, while others will be

introduced and followed up in details in other courses. For example, the

importance of sound data management in clinical research will be discussed in

this course, but the actual techniques of clinical data management will be

covered in a future course dedicated to that area.

Instructors:

(1) Hari Dayal, PhD, FACE, Adjunct Professor of Health Policy and Management,

University of North Texas, Fort Worth, TX, USA.

(2) Santanu K Tripathi, MD, DM, Professor of Clinical & Experimental

Pharmacology, Calcutta School of Tropical Medicine, Kolkata, India

(3) Krishnangshu Ray, MD, PhD, Director, Calcutta School of Tropical Medicine,

Kolkata, India

and Others

Teaching-learning methods: Traditional didactic lectures, Classroom

discussions, Off-class assignments.

Contact hours: A total of 48 contact hours are needed for a three semester

credit hour course. These 48 hours will be organized in six days of 8-hour

sessions each day. Five of the 8 hours in a day will be devoted to didactic

lectures, the remaining 3 hours will be spent on practicum related to the

material covered in the didactic lecture. Home work assignments will be

discussed in the class with student participation.

Credit hours: 3 Semester US Credit Hours Equivalent

Workshop content (Tentative): The six 8-hour sessions will be devoted to the

following topics/areas.

Session #1: The anatomy and physiology of Clinical Research- what it is made of,

how it works. Evidence-based medicine and Clinical Research. The hierarchy of

`evidence' from various study designs, the feasibility of a particular research

design in a given situation, the place of Clinical Trials in evidence-based

medicine.

Session #2: Observational vs experimental approach to Clinical Research, pros

and cons, feasibility issues. Basic observational study designs in Clinical

Research. Defining and prioritizing the research questions in Clinical Research;

translating the research questions into testable hypotheses; consideration of

available study designs to test the stated hypotheses; consideration of

available resources, including clinical material, to complete the study.

Session #3: Ethical and legal issues in Clinical Research; Good Clinical

Practice (GCP) issues; Human Subjects issues and Internal Review Board (IRB);

Informed consent issues. Why a study protocol? Logistical issues in multicenter

studies; essential elements of a good study protocol; selection of study

subjects- inclusion and exclusion criteria.

Session #4: Planning the measurements. Precision and accuracy issues;

measurements on stored materials; prioritizing the outcome measures. Designing

questionnaires and data collection instruments.

Session #5: Critical statistical considerations in Clinical Research I. Type I

and Type II errors. How many study subjects? How long to follow up study

subjects? Why are these questions so important? Critical statistical

considerations in Clinical Research II. Strategies for maximizing the power of

the study; what to do when sample size is fixed by extra-scientific

considerations; estimating sample size with insufficient or imprecise

information.

Session #6: Designing an experiment in Clinical Research. Phases of Clinical

Trials, their distinct objectives and their logical progression. Different

emphases on Type I and Type errors in different phases of the trial. Blinded and

non-blinded clinical trials. Randomization. Units of randomization. Block

randomization. Stratified randomization. Stratified blocked randomization.

Session #7: Fixed sample size and sequential designs in Clinical trials. Trial

monitoring and stopping rules. Class discussion on critical clinical trial

design issues such as randomization, stopping rules, ethical considerations,

trial monitoring. Students would be expected to talk about specific clinical

trials conducted in India. Some significant clinical trials that were stopped

before completion- lessons learned.

Session # 8: Equivalence clinical trials vs traditional hypothesis testing

clinical trials- pros and cons. Research design issues in Phase I and Phase II

trials- some illustrative examples.

Session #9: Class discussion on phase I and II clinical trials with student

presentations and participation. Students would be expected to talk about

specific clinical trials conducted in India. Research design issues in Phase III

trials- some illustrative examples.

Session #10: Class discussion on phase III clinical trials with student

presentations and participation. Students would be expected to talk about

specific clinical trials conducted in India. Issues in data management of

Clinical Research studies.

Session #11: Research design and follow up issues in surveillance studies.

Community trials- special challenges. Importance of community trials in public

health.

Session #12: Clinical trials involving preventive interventions- special

challenges and opportunities.

Final Examination. This will be an open-book examination.

Who should attend?

This new workshop will be of particular interest to all potential and actual

junior and mid-level clinical researchers who seek to keep current with the

rapidly evolving advances in clinical trial design and translational research.

How to apply?

Please register yourself through email / fax. Mention your professional

background and contact details (including your phone no and email ID). Write a

brief paragraph on why you wish to attend this workshop. Also send a scanned

copy of the demand draft (see below for details) for registration fees and

accommodation charges, as applicable. Applications will be accepted only until

27th January, 2011. The number of participants accepted for the workshop is

limited and all applications will be reviewed and selected on a competitive

basis.

Registration Fees

Rs 4,000/= only (cover workshop kit, lunch and inter-session tea/coffee on all

six days)

Accommodation etc.

A limited number of low-cost accommodation (twin-sharing room) are available for

out-station participants. An additional amount of Rs 4,000/= (twin-sharing room)

only is payable that covers accommodation for 7 day & 8 nights, breakfast and

dinner on all the days of stay. Outstation participants are expected to reach

the place of stay on 30th Jan, 2011 by the evening. They should plan their

return journey either in the afternoon / evening of 5th Feb, 2011 or in the

morning of 6th Feb, 2011.

Payments

Payment should be made by Demand Draft on any Bank in Kolkata in favour of

Society of Tropical Medicine and Infectious Diseases in India, that must reach

the undernoted address (address for correspondence) before 27th January, 2011.

Address for correspondence:

Dr. Santanu K Tripathi, MD, DM

Professor of Clinical & Experimental Pharmacology

School of Tropical Medicine, Kolkata 700073

Email : tripathi.santanu@...

Cellphone : (0) 92305 66771

Fax : 033-2257 3598, 033-2241 4915