~Week 7 in BeST Programme~

Assalamualaikum wbt.

From 10 to 14th January 2011, we had a long session on clinical research, conducted by Clinical Research Skills Training & Events (CReST EvendZ)

10 January 2011

- We start the session on Intellectual Property Protection in Malaysia, delivered by Assoc. Prof. Rohazar Wati Zuallcobley. What so important about patent? Well, analogically it's like getting a birth certificate for a newborn baby. In clinical research especially, patent is so important as it protect the product or in this case known as intellectual properties from being copied by other parties. In Malaysia, the patent is administered by Intellectual Property Corporation of Malaysia (MyIPO). We've told about the patent, trade mark and confidential information and trade secret.

11 January 2011

- Today, we discussed on Introduction of Clinical Research and Ethics, presented by Dr. Sia Koon Ket. Simply, clinical research is a research involving human being. Clinical trial need to be done first to ensure its safety and it can be classified into 5 phases ; 

Phase 0 -- treatment on animals to collect data of safety

Phase I -- testing on healthy human being (evaluate safety, safe dosage range, and side effects identification

Phase II -- test on patient (determine effectiveness, short-term effects and risks.

Phase III -- test on larger group of patient (confirmation of side effects and safety, comparison with commonly used treatment)

Phase IV -- after drug has been marketed (post marketing)

12 January 2011

- We continued with Sponsor's Role in Clinical Research  by Miss Adeline Kwok. We discussed on the role and importance of ICH GCP, IRB/EC and also adverse event surveillance.

13 January 2011

- We proceed with Regulatory Practices in Malaysia and GXP, presented by Dr. Kamaruzaman Saleh and Dr Tajuddin Akasah. We've been discussing on Organization for Economic Co-operation and Development (OECD) which mainly function to promote policies that will improve the economic and social well-being. Then, we proceeded with their guidelines on Good Laboratory Practices (GLP). Next, we discussed on application for Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) in Malaysia and also the concept of quality assurance, control and audit in Good Clinical Practices (GCP). We ended the day with discussion on quality and Good Manufacturing Practices (GMP).

14 January 2011
- We continued the session on clinical research today discussing on clinical data management and the role of biostatistician in IIT clinical trial. The speakers were Ms. Teo Jau Shya and Ms. Lena Yeap Lay Ling. First, we learned on the characteristics of good clinical data management and data ethics. Next, we proceeded with the Independent Data Monitoring Committee (IDMC) and also the importance of biostatistic in performing clinical research.