ABCs of Randomized Clinical Trials

WORKSHOP : ABCs of RANDOMIZED CONTROLLED TRIALS for Health
Professionals
Day One Objectives:
To:
Review the clinical evidence hierarchy
Classify analytical studies
Explore the spectrum of translational research
Categorize clinical trials and sub-types,
Study the importance of bias, contamination, confounding and effect modification
Imbibe the importance of internal and external validity
Assess types of Interventions and endpoints
Study eligibility including key features of inclusion/exclusion criteria
Appreciate the pitfalls in recruitment and retention of trial subjects
Review key characteristics in calculating sample size
Evaluate the importance of Data safety monitoring boards (DSMB) and Interim
Analysis
Appreciate limitations of and adjustment for missing data
Formulate a study question and importance of preliminary hypothesis testing
Day Two Objectives:
Through a detailed study of NEJM Article (DAPA CKD trial) to:
Review types and importance of randomization
Appreciate the need for allocation concealment
Differentiate different levels of masking/blinding
Categorize analyses as intention to treat, per protocol, modified intention to treat
Calculate sample size for “DAPA CKD” study
Appreciate forms of and applied aspects of statistical analyses
Review concept of ethics and equipoise in RCTs
Apply elements of Consort statement 2025 in designing, conducting and reporting
RCTs
Present a schematic of a clinical trial unit
Revisit our legacy in clinical trials: Razi and Ibne Sina
Review Key references
Assess learning outcomes through an interactive post-test quiz

Workshop Director:
Professor Khaja H Mujtaba Quadri MBBS ( Dow) MD (USA)
Diplomate American Board of Internal Medicine 1990-2031
Diplomate American Board of Nephrology. 1992-2031
Certified in Principles and Practice of Clinical Research (Harvard), USA
Head and Consultant Nephrologist, Maroof International Hospital, Islamabad,
Pakistan
Past : Inaugural Chair Research , Pakistan Society of Nephrology
Inaugural Dean, Research, ORIC and Academic Development,
and Professor of Medicine,
National University of Medical Sciences, Rawalpindi, Pakistan
Inaugural Director, Shifa Clnical Research Center,

Comstech ( OIC) RCT workshops (Lead trainer ) 2021, 2023
Shifa International Hospital, Islamabad, Pakistan
Inaugural Chair, Maroof Clnical Research Department,
Maroof International Hospital, Islamabad, Pakistan
Professor and Chairman Medicine, King Saud bin AbdulAziz University of
Health Sciences and Chair Hospital Ethics Committee ,
King AbdulAziz Medical City, Jeddah, KSA
Professor and Chair Medicine, Shifa College of Medicine and
Shifa International Hospital, Islamabad, Pakistan
Assistant Professor of Medicine, University of Pittsburgh, Pittsburgh, PA,
USA
Trained todate 3000 health care professionals in clnical research/ RCTs