Clinical Research Malaysia
-
Upload
suhazeli-abdullah -
Category
Documents
-
view
218 -
download
0
Transcript of Clinical Research Malaysia
![Page 1: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/1.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 1/16
CLINICAL RESEARCH MALAY
(CRM)CRM &
Industry Sponsored Research (ISR)
17th MALAYSIAN FAMILY MEDICINE SCIENTIFIC CONFERENCE 20
4th – 7th July 2013
![Page 2: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/2.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 2/16
CLINICAL RESEARCH MALAYSIA (CRM
ABOUT US
Clinical Research Malaysia (CRM) is a company fully owned byGovernment of Malaysia set up less than 10 months ago and a not for profit entity. The focus of the company is Industry SpResearch, with the vision to make Malaysia as the preferred dfor the industry
![Page 3: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/3.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 3/16
CLINICAL RESEARCH MALAYSIA (CRCRM’S FOCUS• Improving sites by addressing their needs and allocating trained st
coordinators.• Increasing investigators through mentoring programmes, training acampaigns.
• Implementing strategies and procedures for feasibility assessmentinvestigator selections.
• Providing transparent and efficient trial budget management.
• Initiating collaborations with local, regional and global stakeholde• Impacting global pharmaceutical companies and clinical research o
to invest in Malaysia.
• Inspiring private hospitals and universities to be part of this nation
• Investigating and addressing the perception and awareness of clin
among healthcare professionals, administrators, patients and the pu
![Page 4: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/4.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 4/16
Industry Sponsored Research (ISR)• Industry-Sponsored Clinical Trials are a subset of clinical research
include ALL THREE of the following factors in order to qualify for thtrial indirect cost rate:
1. The objective of the study is either:
• Testing of drugs, devices, diagnostics, treatments, interventionpreventive measures including testing for an unapproved indic
•
Data collection to increase knowledge that would lead to enhaand efficacy of a specified drug or device; AND
2. The study must involve contact with humans or retrospective revmedical records, clinical data or specimens obtained from contact w
3. The study must be industry sponsored or funded
![Page 5: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/5.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 5/16
Malaysia – Destination for ISR
• Investment to the country
•Employment
• Fully supported by Government
• Adequate research infrastructure to support the clinical stud
• Sufficient trained & experienced research staff
•
Experienced and Qualified Investigators• High subject Recruitment Rate and Retention Rate
• Qualified and Efficient IRB/IEC (on approval timeline)
• Good quality of clinical trial’s data
• Good network of clinical research centres (CRC)
![Page 6: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/6.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 6/16
Creating the ideal landscape
2007
A unit within theMinistry of Healththat facilitates
industry sponsored
research
2010
Became a project for
the HealthcareNational Key Economic
Area
2012Corporatised
body.Governmentowned, not-for-profit
Vision:
Malaysia as the preferred
destination for contract clinical
research
![Page 7: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/7.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 7/16
Info on number of ISR (by CRM)
11
12
23
13
18
14
12 12
18
16
0
5
10
15
20
25
30
January February March April May June July August September October N
No of new research approved monthly in 2012
![Page 8: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/8.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 8/16
Top 10 Therapeutic Area for ISR
![Page 9: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/9.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 9/16
Top 10 Sponsors for ISR
![Page 10: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/10.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 10/16
![Page 11: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/11.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 11/16
• Engage Regulators
• Engaging Industry (CRO, Pharma)
•
Engaging Service Heads in MOH, Pengarahs, ancilliaservices
• Building Research interest by participating in all staResearch Days
• Building forums and sponsoring speakers for these
meetings.
• Training (GCP, Study Coordinators)
• Engaging Medical Societies
• Participating in overseas conferences
![Page 12: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/12.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 12/16
Promoting Industry Sponsored Research:
• MOH Hospitals/KK - collaborative effort with CRC
• Private hospitals – collaborative effort through Associationprivate hospitals
• University Hospital – Collaborative effort with MOHE
![Page 13: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/13.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 13/16
Malaysian PROTEGES 2013
(PReparing Outstanding Clinical Research Talents by EnGaging Eminent Malaysi
I. Initiation Workshop for MentorsII. Initiation Workshop for Mentees
First programme was held on 13 and 27 April 2013
Second programme will be held on 11 and 25 July 2013
This programme will be conducted throughout Malaysia in the following region
1. Central Region: (Kuala Lumpur, Selangor, Putrajaya)2. Southern Region (Johor, Negeri Sembilan, Melaka)3. Northern Region (Penang, Kedah, Perlis, Perak)4. Eastern Region (Kelantan, Terengganu, Pahang)5. Sabah6. Sarawak
![Page 14: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/14.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 14/16
GCP Workshop• Fully organized by CRM
• Few venues has been proposed (according to region) – Nort
(Kedah), East Coast (Kelantan), Central (Putrajaya) & Sarawak
• Comparatively more affordable registration’s fee
Personalise visits• Identify new sites
• Meeting KOLs
• Engaging private hospital, Melaka, Kuala Lumpur & Penang iOncology, cardio & Psychiatry
![Page 15: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/15.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 15/16
Contract management
1. (i) Clinical Trial Agreement, review
(ii) Clinical Trial Amendment
2. Budget review
![Page 16: Clinical Research Malaysia](https://reader031.fdocuments.us/reader031/viewer/2022021122/577cda9d1a28ab9e78a61278/html5/thumbnails/16.jpg)
7/27/2019 Clinical Research Malaysia
http://slidepdf.com/reader/full/clinical-research-malaysia 16/16
QUESTION & ANSWER SESSION
For further information, please contact:
Clinical Research Malaysia (1006282-X)
Address: Suite E-10-20, Amcorp Business Suites
Menara Melawangi, Amcorp Trade Centre,No. 18, Jalan Persiaran Barat, 46050 Petaling Jaya,
Tel: 603-79605153; Fax: 603-79321940