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 a/l Lohanathan(Science Officer)
Contact No: 03-79492886
Email: banusanthar@ummc.edu.my 

FINANCIAL MATTERS

Mr. Akklil Aiman bin Othman (Head of Finance)
Contact No : 03 79492886
Email: akklil@ummc.edu.my

Miss Rizatul Itaelya Mohd Sahimi (Account Assistant)
Contact No : 03 79492351
Email: itaelya@ummc.edu.my

LEGAL MATTERS

(CLINICAL TRIAL AGREEMENT)
Kartialiny a/p Sivadahasan (Legal Officer)
Contact No : 03 79492886
Email:  kartialiny@ummc.edu.my

BUDGET NEGOTIATION

Juliana Wang Piek Lian (Science Officer)
Contact No : 03 79492886
Email: wagpl@ummc.edu.my

Nurul Zfarina binti Mohd Zaid (Assistant Science Officer)
Contact No : 03 79492886
Email: nurulzfarina.zaid@um.edu.my

TRAINING AND FACILITIES


Nur Hidayah Zakaria (Medical Lab Technologist)
Contact No: 03-7949 2886
Email: hiedayah@um.edu.my

Anis Nabila Izham (Assistant Science Officer)
Contact No: 03-7949 2886
Email: anisnabila@um.edu.my