EVENTS & NEWS
ARE YOU INTERESTED?
No. |
Study Title |
Specialty |
Register Interest |
---|---|---|---|
1. |
Implementation of the National Antimicrobial Prescribing Survey (NAPS) And Identification of Targets to Improve Judicious Use of Antimicrobials and Evaluation of Interventions to Address these Targets in Two Malaysia Teaching Hospitals, University of Malaya Medical Centre (UMMC) and the Malaysia National University Medical Centre (UKMMC)
|
Infectious Disease |
|
2. |
A two-part randomized, Phase 3 Study of combinantions of cemiplimab (Anti-PD-1) Antibody and Platinum- based Doublet Chemotheraphy in First-line treatment of patients with advanced or Metastatic non-small cell lung cancer
|
Oncology
|
|
3. |
A prospective, multicentric, single-arm study to evaluate the safety and efficacy of the UNITY-B Biodegradable Balloon Expandable Biliary Stent System in subjects with biliary strictures
|
Gastroeneterology
|
|
4. |
A phase 4 Double-blinded, randomized, active comparator-controlled clinical trial to study the eficacy, safety, and pharmacokinetics of sugammadex (MK-8616) for reversal of neuromuscular blockade in Pediatric participants aged birth to <2 years.
|
Anesthesiology |
|
5. |
Hyperthermia in treating patients with painful unresectable abdominal or pelvic malignancy. |
Oncology
|
|
6. |
Immune modulatory effect of hyperthemia during treatment of recurrent or metastatic solid organ malignancies
|
Oncology
|
|
7. |
1/2 PROSpect: Prone and Oscillation Pediatric Clinical Trial (CCC)
|
Paediatrics
|
|
8. |
An open-label, non-randomized, multi-center extension study to evaluate the long-term safety and efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).
|
Haematology
|
|
9. |
A Double-Blind Placebo-Controlled, Randomized Withdrawal Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-Redcution Paradigm in the Prevention of Relapse in Patients with Schizophrenia
|
Psychological Medicine
|
|
10. |
A 52-week, phase 3, multicenter, randomized, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with
methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.
|
Rheumatology
|
|
11. |
A Prospective, Randomized, Open-Label, Comparative Study to Assess The Efficacy, Safety And Tolerability of Aztreonam-Avibactam (ATM-AVI) And Best Available Therapy For The Treatment Of Serious Infections Due To Multi-Drug Resistant Gram-Negative Bacteria Producing Metallo-Β-Lactamase (MBL)
|
Infectious Disease
|
|
12. |
A Phase III, Randomized, Double-blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
|
Oncology
|
|
13. |
A Post Market Registry of Abluminus® Sirolimus Eluting Coronary Stent System for Percutaneous Intervention in Patients With Diabetes Mellitus
|
Cardiology
|
|
14. |
A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1, 50%.
|
Respiratory
|
|
15. |
A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)
|
Oncology
|
FAQ
Know you answer from your questions
ELECTRONIC MEDICAL RECORD (EMR)
FLOWCHART ON HOW TO CONDUCT CLINICAL TRIAL THROUGH CIC
GUIDELINE FOR APPLYING MEDICAL ETHICS COMITTEE
PHASES OF CLINICAL TRIALS (PHASE I, II, III, IV)
PHASE I
Phase 1 studies are usually conducted in healthy volunteers. The goal here is to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80..
PHASE II
Phase 2 studies begin if Phase 1 studies don’t reveal unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment–usually an inactive substance (placebo), or a different drug. Safety continues to be evaluated, and short-term side effects are studied. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300
PHASE III
Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.
PHASE IV
Phase IV trials gather more information about the possible risks and benefits of a drug that didn’t show up in earlier testing. Researchers look into risks and benefits that could be associated with long-term effects after a drug or treatment has been approved for clinical use. In this phase, researchers continue to follow participants who have completed phase III trials. Not all new treatments will enter into phase IV studies
IF YOU HAVE ANY QUERIES REGARDING THE BELOW ITEMS, KINDLY CONTACT
I-RESEARCH APPLICATION
Mr. Banusanthar Lohanathan(Science Officer)
Contact No: 03-7949 2351
Email: banusanthar@ummc.edu.my
Ms. Khairulbariah Baharum(IT Officer)
Contact No: 03-7949 2351
Email: khairulbariah@ummc.edu.my
FINANCIAL MATTERS
Ms. Noor Aziza Ismail @ Aziz(Accountant)
Contact No : 03 7949 2886
Email: aziza.ismail@ummc.edu.my
Mdm. Nur Fathin Maisarah Azami (Account Assistant)
Contact No : 03 7949 2886
Email: fathinm@ummc.edu.my
Mdm. Nur ‘Ain Haris (Account Assistant)
Contact No : 03 7949 2886
Email: nurain.haris@ummc.edu.my
LEGAL MATTERS
(CLINICAL TRIAL AGREEMENT)
Ms. Nurul Najihah Saupi (Legal Officer)
Contact No : 03 7949 2886
Email: najihah.saupi@ummc.edu.my
Ms. Nahra Yasmin Anuar (Legal Officer)
Contact No : 03 7949 2886
Email: nahra.anuar@ummc.edu.my
BUDGET NEGOTIATION
Ms. Juliana Wang Piek Lian (Science Officer)
Contact No : 03 7949 2886
Email: wangpl@ummc.edu.my
Ms. Nurbazlin Musa (Science Officer)
Contact No : 03 7949 2886
Email: nurbazlin@ummc.edu.my
Mdm. Nurul Zfarina Mohd Zaid (Assistant Science Officer)
Contact No : 03 7949 2886
Email: nurulzfarina.zaid@um.edu.my
TRAINING AND FACILITIES
Mdm. Nur Hidayah Zakaria (Medical Lab Technologist)
Contact No: 03-7949 2351
Email: hiedayah@um.edu.my
Ms. Hanis Hafizah Ismail(Science Officer)
Contact No: 03-7949 2351
Email: hanishafizah@ummc.edu.my