Clinical Trials Course

“Design, Analyses, Interpretation and Reporting”

July 13-17, 2009

Course offered by
Biostatistics Resource and Training Centre,
Department of Biostatistics, Christian Medical College,
Vellore, India.

In collaboration with the Department of Biostatistics,

University of North Carolina, Chapel Hill, USA.

www.cmc-biostatistics.ac.in
Course Description:
This course provides thorough knowledge in the principles and practice of clinical trials to
study the effect of an intervention on health outcomes. This will include lectures,
practicals, participant’s presentation, and group work.

Course Objectives:

• To impart knowledge in principles and practices of controlled clinical trials,

through lectures and practicals
• To impart the basic concepts in Ethical issues in research, Journal critique and
in Systematic reviews.
• To discuss and clarify the methodological challenges in the planning, conduct
and analyses of a trial.
• To impart the basic skills necessary in monitoring the trial and to develop a
quality data management system.

Who should apply?

This course is tailored to researchers working in Pharmaceutical Industries, medical, allied
health professionals, nonmedical faculty and researchers actively involved in trials, or
teaching or in furthering their knowledge and skills in methodology.

Benefits:

• The participants will be provided with a copy of nMaster1.0 sample size calculation
software.

• Each participant will be randomly allocated to a group and the group will be
assigned a research question and given background materials to develop a
protocol following GCP and CONSORT guidelines. Each group’s protocol
development process will be facilitated by a mentor. Each group will be asked to
present their protocol orally to the rest of the groups and faculty for discussion.

Course Fee & Accommodation:

Rs10, 000/ USD $ 200 per person
(Lunch, snacks and tea will be provided)

Course Fee should be paid in full by June 30, 2009. Payment can be made by Demand
Draft in favour of “Christian Medical College Vellore Association Account “, payable at
Vellore. The organisers may arrange accommodation on request inside the Campus.
The room rent will be Rs. 250/- per head / per day in a shared room (A/c - Double
bed room).
Venue:

Biostatistics Resource and Training Centre (BRTC),

Department of Biostatistics,
Christian Medical College,
Bagayam,
Vellore - 632 002.

The number of participants: limited to 30 admissions will be purely on first come first
served basis.

Secretariat / Contact person

Mr. C. Jayaprakash
Dept. of Biostatistics,
Christian Medical College,
Vellore – 632 002, India.
Email: biostats@cmcvellore.ac.in
Phone: (0416) 2262703, 2284205

Course Co-ordinator:

Dr. L. Jeyaseelan Ph.D, FRSS, FSMS

Professor & Head
Dept. of Biostatistics,
Christian Medical College,
Vellore – 632 002, India.
Email: biostats@cmcvellore.ac.in, ljey@hotmail.com
About Faculty:

Dr. Shrikant I Bangdiwala graduated in Mathematics and subsequently received his PhD
in Biostatistics from The University of North Carolina at Chapel Hill (UNC) in 1980, where
he currently holds the rank of Research Professor of Biostatistics. He currently is
designated as a ‘Fulbright Senior Specialist’ in Global Public Health. He was the chair of
two Data and Safety Monitoring Boards (DSMB) and a member of nine DSMBs. He has
been co-investigator for over 10 clinical trials projects. He has been the faculty for over 25
clinical trial related workshops and short courses. He has over 20 publications alone on
clinical trials and over 100 publications in public health and medicine. He is one of the
founding members of the Injury Prevention and Research Centre of UNC, and currently is
a member of the Board of Scientific Counselors of the National Centre for Injury
Prevention and Control. He has been teaching clinical trials for the graduate program at
UNC. He is a biostatistical advisor for the International Clinical Epidemiology Network
(INCLEN) and a visiting faculty for the Department of Biostatistics, Christian Medical
College, Vellore, India.

Dr. Prathap Tharyan, MD, MRCPsych, Professor of Psychiatry, trained for his MBBS and
MD at CMC Vellore. He joined the department in 1987 and has worked here since except
for three years (1992-1995), when he worked at Oxford in the UK towards the MRCPsych
(1994). He was head of Psychiatry Unit II from 1996- 2007 and of the Department of
Psychiatry from 2003-2007. He was additional Vice-Principal (Research) at CMC from
2006 June –January 2008. He is currently Associate Director for CMC from Feb 2008. He
is the Director of the Prof. BV Moses and ICMR Advanced Centre for Research and
Training in Evidence Informed Health Care at CMC Vellore and Director of the South
Asian Cochrane Network (www.cochrane-sacn.org) a part of the international Cochrane
Collaboration (www.cochrane.org). He is also an Editor with the Cochrane Schizophrenia
Group and a systematic review author with several other Cochrane review Groups. He is
an associate editor of the biomed central journal ‘Trials’ and of the ‘Journal of Evidence
Based Medicine’. He is also a member of the Scientific Advisory Group of the WHO-
International Clinical Trials Registry Platform and the WHO Guidelines Review Committee.
He is a member of the steering and technical advisory groups of the Clinical Trials
Registry-India (www.ctri.in). His areas of interest are evidence-based health care,
conducting pragmatic clinical trials and evidence-based ethics.

Dr. Ashwini Mathur, Ph.D, Head, Clinical Information Sciences and Adjunct Faculty at
Institute of Bioinformatics and Applied Biology, received his Ph.D. in Biostatistics from
University of California, Berkeley and subsequently taught as a faculty member at
University of California, San Francisco before joining GSK (US) in 1996. He headed
GSK's Biometrics operations in India till 2006 and now heads a similar function at Novartis
in Hyderabad, India. He is a member of American Statistical Association and Secretary of
International Biometrics Society. He has more than 35 medical collaborative papers in
international journals, 2 book chapters and numerous invited lectures, presentations and
posters at international conferences.
Dr. L. Jeyaseelan is Professor of Biostatistics at the Department of Biostatistics, Christian
Medical College, Vellore. He has been teaching Epidemiology and Clinical Epidemiology
for the Masters Program at this Department. He is the founder of the Biostatistics and
Resource and Training Centre (BRTC). He has been organizing short courses in
Biostatistics, Epidemiology, and Advanced Statistics Methods for the last 8 years. He is
also the founder of the Clinical Data Management Centre (CDMC). He is the Chair of
DSMB at the Christian Medical College, Vellore. He is also member of the DSMB of
Department of Biotechnology (DBT) and WHO. He has published over 80 papers in public
health and medicine. He is the PI of the nMaster sample size calculation software from
this Department. He is Investigator and Co-investigator of nearly 10 Epidemiological
studies.
 Course content
Monday July 13:

Day 1: Building the Evidence

09.00 – 10.30 Refining the research question

– observational vs. experimental
Review of research designs
Confounding in research

11.00 – 13.00 Statistical considerations on design:

Phase I, II and III trials
- superiority vs non-inferiority

14.00 - 15.30 Systematic reviews, meta analyses

Cochrane Collaboration in SE Asia

16.00 - 17.30 Journal critique guidelines

Evening Participants to refine their group’s research question,

review the evidence, and elaborate their hypothesis

Tuesday July 14:

Day 2: Design and Conduct Issues

09.00 -10.30 Design alternatives for Phase I, II, III trials

- Parallel, crossover and factorial designs
- Ethical considerations – placebo or control arm
- Masking and allocation concealment
- GCP principles
- Quality assurance

11.00 - 13.00 Intervention allocation

- Simple, stratified, cluster randomization
- Adaptive randomization schemes
- Blocking; permuted blocks
- Optimized randomization
Exercise with SAS/STATA
Case studies with challenges

14.00 - 15.30 Ethics in clinical research

16.00 - 17.30 Necessary sample size

Exercises using nMaster1.0

Evening Participants to develop their group’s study design,

randomization scheme, and required sample size
Wednesday July 15:

Day 3: Data Analyses and Monitoring Issues

09.00 - 10.30 Statistical methods for end-of-study analyses

- Phase I, II, and III trials
- Hypotheses of superiority vs non-inferiority
- Analysis of crossover and factorial designs
- Statistical tests - survival analysis, logrank, M-H
- Use of post-randomization information (adherence)
- ITT, per-protocol, ‘completors’

11.00 - 13.00 Statistical methods for interim analyses

- Group-sequential boundaries
- Stochastic curtailment
- Conditional power
- Statistical implications of early stopping

14.00 – 15.30 Data and Safety Monitoring Boards

- Role and responsibilities
- Case studies of early stopping

16.00 - 17.30 Journal article critique by participants

Evening Participants develop their protocol’s analysis strategy

Thursday July 16:

Day 4: Data Analyses & Study Management

09.00 -10.30 Handling missing data: imputations and challenges

Adjusting for baseline variables
- Methodological issues

11.00 – 13.00 Secondary analysis

- Secondary analyses of the primary outcome
- Secondary outcomes
- Sub-group analyses: Uses and abuses
- Bias in Randomized Controlled Trials

14.00 – 15.30 Study management

- Monitoring process
- Coordinating protocol implementation
- Internal & external reporting
16.00 – 17.30 Multicentre vs multi-site studies
- Study governance
- Publication management

Evening Participants finalize their protocols

Friday July 17:

Day 5: Clinical Data Management and Monitoring

09.00 -10.30 Ethical considerations

Adverse event coding and reporting
Role and responsibilities of the PI, Sponsor

11.00 -13.00 Case Studies Presentation.

14.00 – 15.30 Presentation of participant’s protocols

15.30 – 16.00 Workshop evaluation

******
 Format of Application

Name in Capital _______________________________

( for Certificate purpose)

Age ______ Sex M / F

Occupation ___________________________________

Activities ___________________________________

Address ___________________________________

___________________________________

___________________________________

Phone & Mobile ________________________________

Email ___________________________________

Educational Background
Degree __________________________________

Area of Concentration __________________________

Have you ever taken Epidemiology/Biostatistics Course earlier Y /N

Accommodation: Required / Not Required

DD Amount Rs. _______________ Date: ____________

DD Number: ____________________ Bank: _______________

 Tourist Attractions

Jalakandeswarar Temple-Vellore Fort

The temple which had been built in the late Vijayanagar style, comprised
of the main shrine and closed ambulatory passage around, and the integral
Mahamantapa, with a northward projecting sub-deshrine for Nataraja,
containing also several other sub-shrines. The temple has two court yards,
one is inner prakara and the other is outer prakara - The structures in the
court yard on the outer prakara include the lofty Gopuram on the southern
side which is the entry point to the temple. On the , South-West corner of outer court yard is the
Kalyanamantapa which is the gem of architecture of I ate Vijayanagar style in embellishments and
the art motifs of its pillars, ceilings and plinth mouldings, It stands as testimony for the architectural
workmanship of that period.

Sripuram Golden Temple

A Mahalakshmi temple called 'Sripuram' and made of more than a
tonne of pure gold will glitter and gleam under the sun on August 24
when it is unveiled for consecration by the Sri Narayani Peetam
headed by a 31-year-old godman who calls himself Narayani Amma.
Devotees hail the temple as one of the wonders of the world and say
that it is the only temple covered fully with gold.

More than 400 gold and coppersmiths from the Thirupathi Thirumala
Devasthanam are said to have worked for six years to craft the Rs 600-crore gold temple located on
55,000 sq ft of land on a 100-acre salubrious stretch in Malaikodi, about 6 km from Vellore in north
Tamil Nadu.

First the coppersmiths set to work creating a copper base on the temple structure with engravings
and etchings before the gold, beaten into nine layers of foils, was draped around it. The sanctum
sanctorum will hold the deity of Mahalakshmi made of stone granite, but covered with gold
kavacham (adornments).

"The Sripuram or Spiritual Park is Amma's dedication to the world and mankind," said P Murali, a
trustee of the Peetam, adding that the temple has more gold than the Golden Temple of Amritsar.

Kanchipuram:

Silk Industries

About 75% of Kanchipuram’s population is dependent on the Silk Saree industry, either directly or
indirectly. Yet, the city does not manufacture Silk or any other raw material that goes into its silk
sarees. The Silk industry is entirely made up of Handloom weavers and merchants.
Ekambareswarar Temple

This is another ancient temple of Kanchipuram. It has been renovated by the Pallavas, the Cholas
and the Vijayanagar kings. The 57 meters high Rajagopuram is one of the tallest towers in South
India This Temple has 5 spacious corridors and a beautiful 1000 pillar hall. The huge Linga inside
is known as ‘Prithvilingam’, one of the pancha lingas of South India.

Kamakshi Amman Temple

Built in the 14th century by the Cholas, this temple is dedicated to Goddess Kamakshi the presiding
deity of Kanchi. Here, the goddess is worshipped in the form of a Chakra placed in front of the idol.
An image of Shankaracharya is also worshipped. Sri Sankaracharya is said to have defeated
Buddhist philosophers in debate here. It is one of the three holy places of Sakthi worship in India
the other two being Madurai and Varanasi. The temple has a golden gopuram in the centre. This
imposing temple is the site of the annual chariot festival, held on the 9th lunar day in
February/March.