The Pre-Conference Workshop, as part of the Clinical Trial Summit of Pakistan (CTSP) 2025, was organized by Aga Khan University (AKU) and National University of Medical Sciences (NUMS) in collaboration with Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC), Lahore and Shaikh Zayed Postgraduate Medical Institute, Lahore. The event was supported by the Association of Clinical Research Professionals (ACRP), Drug Regulatory Authority of Pakistan (DRAP), and the Association of Physicians of Pakistani Descent in North America (APPNA).

Workshop Objectives

• Develop a basic understanding of clinical trial design and execution.
• Gain practical skills in protocol writing.
• Understand ethical and regulatory frameworks.
• Learn the process of registering, reporting, and publishing trial outcomes.

Target Audience

The workshop was designed for researchers, clinicians, healthcare professionals, and postgraduate students with an interest in clinical trials. Participation was limited to 25 slots.

Dr. Ayesha Humayun

• Principal at Shaikh Khalifa Bin Zayed Al-Nahyan Medical College, SZPGMI, Lahore.
• Head of Public Health & Community Medicine and Director CTU at Shaikh Zayed PGMI, Lahore.
• Fellow of the College of Physicians and Surgeons Pakistan.
• PhD in Community Medicine with over 120 publications and 27,000+ citations.
• WHO-TDR grantee and member of Stanford University’s top 2% scientists.

Dr. Baber Saeed Khan

• Founding president of ACRP Ambassadors Club of Pakistan.
• Director of Clinical Trial Unit, National University of Medical Sciences (NUMS).
• National consultant for WHO project on patient safety and quality care.
• Conducted 72 clinical trials under FDA regulations in the USA.
• Certified Principal Investigator from ACRP and Fellow of the American Physicians of Clinical Research (FAPCR).

Agenda and Sessions Overview

Session 1: Welcome & Introduction

A brief introduction to the workshop, outlining its objectives and importance in the field of clinical trials.

Session 2: Pre-Test

A pre-test was conducted to assess the baseline knowledge of participants about clinical trials.

Session 3: Introduction to Clinical Trials

Speaker: Dr. Farah Asif

Topics Covered:

• Concept, pre-clinical and clinical trials
• Designing of Phase I, II, III trials
• Phase IV/pragmatic trials
• Blinding and randomization
• Parallel/concurrent and cross-over designs

Session 4: Essentials of Protocol Development

Speaker: Dr. Ayesha Humayun

Topics Covered:

• Basics of protocol development
• Statistical considerations
• Sample size calculations

Session 5: Trial Execution and Monitoring

Speaker: Dr. Ayesha Humayun

Topics Covered:

• Setting up a clinical trial site
• Participant recruitment and retention strategies
• Data collection and documentation standards
• Quality control and assurance measures
• Data safety and management boards

Session 6: Ethical and Regulatory Frameworks

Speaker: Dr. Baber Saeed Khan

Topics Covered:

• Trial registration
• Informed consent process
• Role of Institutional Review Board (IRB)/Ethics Committee
• National and international regulatory guidelines
• Protocol compliance and ongoing communication

Session 7: Post-Test & Certificate Distribution

A post-test was conducted to evaluate participants' learning, followed by feedback collection and certificate distribution.

Conclusion

The Pre-Conference Workshop on Clinical Trials provided a comprehensive understanding of clinical trial design, execution, monitoring, and ethical considerations. Participants gained valuable hands-on experience in protocol writing, sample size calculation, and trial management. The discussions on regulatory compliance and ethical frameworks ensured that attendees are well-prepared for conducting high-quality research. The interactive sessions, including group discussions and post-workshop evaluations, reinforced the key concepts essential for conducting clinical trials in compliance with international standards.

The workshop served as a significant stepping stone for researchers and healthcare professionals, equipping them with the necessary skills and knowledge to design, execute, and report clinical trials effectively.