This document provides details about an upcoming clinical trial course on design, analysis, interpretation and reporting of clinical trials. It includes information about the course faculties from McMaster University and Christian Medical College, Vellore. The 5-day course will cover topics like types of clinical trials, CONSORT guidelines, design considerations, systematic reviews, meta-analysis, statistical analysis methods, sample size calculation and preparing FDA submissions. One of the clinical trials described is about assessing the effect of a preoperative short-term structured exercise program on postoperative quality of recovery in patients undergoing major abdominal cancer surgeries.

1. Clinical Trial course – Design , Analysis , Interpretation and Reporting
Biostatistics Resource and Training Centre
Clinical Epidemiology Unit
Christian Medical College, Vellore, India
In Collaboration with
Department of Health Research Methods
McMaster University, Ontario, Canada
December 11-15, 2017

2. Faculties:
Dr. Shrikant I Bangdiwala:
BSc to PhD in Univ of North Caroline , USA
36 Years of Research in Biostatistics in UNC
Statistics Director of Department of Health Research Methods
McMaster University, Ontario, Canada
Dr Thambu David Sudarsanam
Professor of Medicine, CMC, Vellore
Clinical epidemiology coordinator
Dr. Abraham Peedicayil
Professor and Head, Dept. of Obstetrics and Gynaecology
Epidemiology Research in Gynae. Oncology

3. Dr. L Jeyaseelan, Course Co-Ordinator
Prof of Biostatistics at Dept. of Biostatistics, CMC
Biostatistics Resources and Training Centre (BRTS)
Dr Visalakshi Jeyaseelan
Senior Lecturer, Dept. of Biostatistics, CMC
Clinical Trials, Bootstrap Techniques, Bayesian Modeling

4. Introduction to Clinical Trials
Dr Abraham P
Clinical Trials: Powerful experimental Technique for assessing
the effectiveness of an Intervension
Essential Elements:
• Prospective (Subject followed forward)
• Intervension (Design of therapy)
• Control (Comparable ….Placebo)
• Randomization
• Double Blinding (Systematic Bias)
Inauguration
Day 1

5. Types of Clinical Trial :
•Treatment
•Prevention
•Early Detection
•Diagnostics
•Quality of life
Clinical Trial Question
Questions determine the design of Clin Trial

6. CONSORT: Consolidated Standard of Reporting Trials

7. Design Consideration:
Superiority; Inferiority and Non-Inferiority
Parallel,Crossover and Factorial Design
Adaptive Design

8. Day 2

10. Systematic Reviewing

11. Meta Analysis

12. Day3
Statistical Method for End of Study Analysis
Primary Study Out come
Crossover and Factorial analysis
Survival Analysis
Statistical Method for Interim Analysis
Group Sequential Method
Stochastic Method
Coditional pwer

13. Day 4
How to Prepare FDA submission
Smple Size Calculation
nMaster2.0

14. Title: Effect of preoperative short term structured
exercise programme on postoperative quality of
recovery (QoR) after major abdominal cancer
surgeries

15. Hypothesis
• Physical activity are associated with substantial health benefits
in the perioperative context.
• Physical activity is associated with a lower incidence of
cardiovascular disease, cerebrovascular and venous
thromboembolic events and cancer.
• Physical activity has been associated with slower progression
of cancer and slower declines in physical and mental
functioning.
• Physical activity is associated with a lower incidence of
morbidity and mortality after surgery.
Hypothesis: H0 : Exercise Group = No Exercise Group
H1 : Exercise Group ≠ No Exercise Group

16. Research Question
• Already proven then WHY?
• To assess the effects of short term Structured exercise
programme and its effect on quality of recovery after
major abdominal surgery.
• Few studies have shown that short term exercise do
not reduce the morbidity and the outcome benefits.

17. Outcomes
• Primary Outcome:
Quality of recovery (QoR 15) at 14, 48 hours and at 1
week
• Secondary Outcomes:
1.Post operative morbidity
2. Length of ICU stay
3. Length of Hospital stay
4. Post operative mortality at 30 days.

18. Inclusion Criteria
1. All adult patients ASA 1,2, > 18 years of age undergoing major
abdominal surgery for cancer.
2. Patients with Clinical Frailty scale 2-4.
Exclusion Criteria
1. Clinical frailty index 1 and 5-9.
2. ASA 3,4
2. Patients with Ischaemic Heart Diseases with history of angina
3. Patients with Deep Vein Thrombosis.
4. Patients with Low IQ or mental retardation
5. Language barrier

19. Protocol
Assess for eligibility criteria
Enrolling the patient in to the CT
Explain the benefits of aerobic and breathing exercise before
surgery
Randomisation
Control Group Intervention group

20. Intervention Group
• Explain about the Structured Exercise
programme
• Give a programme schedule and tell them to
mark whether it is done or not
• Structured Exercise Programme
Breathing Exercise: PEFM – Inspiratory and expiratory – 10 mins
morning and evening.
Physical Exercise: 5 mins of warm up, 20 mins of moderate exercise, 5 mins of
cooling minimum of 150 mins/ week. (Brisk walking, cycling)
For a minimum period of 2 weeks, they can continues till the day before
surgery

21. Control Group
• Ask them to mark if they are doing exercise
and if so, how long and how active.
• Give them also a programme schedule for 2
weeks to mark the exercise activity.

23. QoR 15