This workshop provides a focused and practical overview of essential elements required for initiating clinical trials. The session will cover three key areas:
a) Preclinical data requirements for clinical trial applications,
b) The different categories of clinical trials, and
c) Common myths and pitfalls that may hinder trial integrity and execution.
Participants will gain practical insights into study planning, and real-world challenges in clinical trial implementation. This workshop is ideal for investigators, sponsors, and research teams aiming to enhance their trial readiness and conduct high-quality research.
Max no of participants: Unlimited
Venue: Mini Auditorium, HSAAS UPM
TENTATIVE PROGRAMME SCHEDULE
Time | Session Title | Speaker / Facilitator |
|---|---|---|
09:00 – 10:00 | Session 1: Preclinical Data Requirements for Clinical Trial • Key preclinical studies: pharmacology, toxicology, and PK/PD • Translating nonclinical data into human safety profiles | Dr Sharon Ng Shi Min Clinical Pharmacologist, Centre for Clinical Trials, Hospital Ampang |
10:00 – 11:00 | Session 2: Understanding the Different Categories of Clinical Trials • Overview of Phase I–IV, BA/BE, and IITs • Distinction between exploratory and confirmatory trials • Distinction based on objectives (superiority, equivalence, etc) | Mr Chew Chun Keat Technical Head Centre for Clinical Trials, Institute for Clinical Research, Hospital Ampang |
11:00 – 11:15 | Break | |
11:15 – 12:00 | Session 3: Common Myths and Pitfalls in Clinical Trials • Misconceptions about approvals, timelines, and oversight • Frequent protocol deviations and documentation issues • Building a culture of compliance and quality | Ms Cheah Kit Yee Clinical Trial Pharmacist, Centre for Clinical Trials, Hospital Ampang |
12:00 – 13:00 | Interactive Panel Discussion: From Ideas to Implementation – What’s Needed to Conduct a Clinical Trial? This interactive session invites participants to share their own study concepts or research interests. Together with the panel, they will explore the necessary steps, designs, approvals, and resources required to transform an idea into a clinical trial proposal. | All Speakers |
EXPECTED OUTCOMES
Participants will:
- Understand how preclinical findings support clinical trial.
- Be able to identify the right category and design for their study.
- Recognize and avoid common pitfalls in planning and operations.
- Gain hands-on guidance on how to turn a research idea into a viable clinical trial.
REQUEST FROM PARTICIPANTS
Ready with research ideas/ synopsis covering:
| Title: | PICO |
| Study Population: | |
| Intervention: | |
| Comparator: | |
| Outcome: | |
| Objectives: Primary Objective: Secondary Objective: | |
| Study Endpoints: Efficacy: Safety: | |
| Methodology: Study design | |
| Sample size: | |
| Duration of study: | |
| Statistical Methods: | |
SPEAKERS
Mr Chew Chun Keat
Technical Head
Mr Chew Chun Keat (CK) is the Technical Head at the Centre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, and a Fellow at the International Vaccine Institute. He played a key role in establishing one of Malaysia’s two NPRA-accredited First-in-Human (FIH) trial centers at Hospital Ampang. The centre has since led and conducted numerous trials, including bioavailability, bioequivalence, vaccine efficacy, drug delivery systems, and drug-drug/food-drug interaction studies.
CK is a board member of the Medical Research and Ethics Committee (MREC) under the Ministry of Health. He also contributed to the enhancement of pharmacovigilance oversight in clinical trials through the development of an online platform for reporting Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR).
He actively supports the World Health Organization (WHO) in alignment with the World Health Assembly’s direction on strengthening national and regional clinical trial ecosystems. He has served on expert panels and working groups involved in the development of key national guidelines, including the Malaysian Guideline for Phase 1 Unit Inspection & Accreditation Programme, Malaysian Phase 1 Clinical Trial Guideline, and A Guide to Conducting Clinical Trials in Malaysia.
Ms Cheah Kit Yee
Clinical Trial Pharmacist
Cheah Kit Yee is a Clinical Trial Pharmacist at the Centre for Clinical Trial (CCT), Institute for Clinical Research, Ministry of Health Malaysia. She holds an MPharm from the University of Strathclyde and has nine years of experience in clinical trial operations.
She has coordinated and managed over ten bioavailability and bioequivalence (BABE) studies, as well as drug-drug interaction (DDI) and bioavailability (BA) trials. Her responsibilities include ethics and regulatory submissions and ensuring that trials are conducted in accordance with approved protocols and timelines. In her role as a Clinical Trial Pharmacist, she oversees investigational product (IP) management—including receipt, storage, preparation, dispensing, accountability, and reconciliation—across more than 20 clinical trials, including Phase III studies involving vaccines and haematological products.
She is also involved in reviewing and maintaining CCT’s standard operating procedures (SOPs) and supports regulatory inspections to uphold the unit’s accreditation under NPRA’s Bioequivalence Centre Compliance and Phase 1 Unit Accreditation Programmes. As part of her current role, she also serves as a member of the Medical Research and Ethics Committee (MREC), supporting the ethical oversight of clinical research.
Dr Sharon Ng Shi Min
Clinical Pharmacologist
Dr. Sharon Ng completed her Masters in Clinical Pharmacology in 2021 with distinction from King’s College London. She has been working in the Clinical Research Ward, Hospital Ampang for the past 11 years and is an experienced clinical investigator who specializes in healthy volunteer research.
She has been the principal or co-investigator in many clinical trials over the years. She also provides consultation on early phase clinical trials and is involved in protocol development and clinical trial conduct. She won Clinical Research Malaysia’s Sponsored Research Award for “Top Recruiter” in 2023.
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