CLINICAL RESEARCH MALAYSIA (CRM)

CRM & Industry Sponsored Research (ISR)

17th MALAYSIAN FAMILY MEDICINE SCIENTIFIC CONFERENCE 2013 4th 7th July 2013

CLINICAL RESEARCH MALAYSIA (CRM)

ABOUT US
Clinical Research Malaysia (CRM) is a company fully owned by the Government of Malaysia set up less than 10 months ago and it runs as a not for prot entity. The focus of the company is Industry Sponsored Research, with the vision to make Malaysia as the preferred destination for the industry

CLINICAL RESEARCH MALAYSIA (CRM)

CRMS FOCUS
Improving sites by addressing their needs and allocating trained study coordinators. Increasing investigators through mentoring programmes, training and awareness campaigns. Implementing strategies and procedures for feasibility assessments and investigator selections. Providing transparent and efcient trial budget management. Initiating collaborations with local, regional and global stakeholders. Impacting global pharmaceutical companies and clinical research organisations to invest in Malaysia. Inspiring private hospitals and universities to be part of this national agenda. Investigating and addressing the perception and awareness of clinical trials among healthcare professionals, administrators, patients and the public.

Industry Sponsored Research (ISR)

Industry-Sponsored Clinical Trials are a subset of clinical research and must include ALL THREE of the following factors in order to qualify for the clinical trial indirect cost rate: 1. The objective of the study is either: Testing of drugs, devices, diagnostics, treatments, interventions, or preventive measures including testing for an unapproved indication; OR Data collection to increase knowledge that would lead to enhanced safety and efficacy of a specified drug or device; AND 2. The study must involve contact with humans or retrospective review of medical records, clinical data or specimens obtained from contact with humans 3. The study must be industry sponsored or funded

Malaysia Destination for ISR

Investment to the country Employment Fully supported by Government Adequate research infrastructure to support the clinical study 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 trials data Good network of clinical research centres (CRC)

Creating the ideal landscape

Vision: Malaysia as the preferred destination for contract clinical research

2012 Corporatised body. Government owned, notfor-profit

2007 A unit within the Ministry of Health that facilitates industry sponsored research

2010 Became a project for the Healthcare National Key Economic Area

Info on number of ISR (by CRM)

No of new research approved monthly in 2012
30

New -179

26 25 23

20 18 18

16
15 13 12 11 10 12 12 14

0 January February March April May June July August September October November December

Top 10 Therapeutic Area for ISR

Top 10 Sponsors for ISR

 Engage Regulators Engaging Industry (CRO, Pharma) Engaging Service Heads in MOH, Pengarahs, ancilliary services Building Research interest by participating in all state Research Days Building forums and sponsoring speakers for these meetings. Training (GCP, Study Coordinators) Engaging Medical Societies Participating in overseas conferences

Promoting Industry Sponsored Research: MOH Hospitals/KK - collaborative effort with CRC Private hospitals collaborative effort through Association of private hospitals University Hospital Collaborative effort with MOHE

Malaysian PROTEGES 2013

(PReparing Outstanding Clinical Research Talents by EnGaging Eminent Malaysian Scientists) I. Initiation Workshop for Mentors II. 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 regions: 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. Sabah 6. Sarawak

GCP Workshop
Fully organized by CRM Few venues has been proposed (according to region) Northern (Kedah), East Coast (Kelantan), Central (Putrajaya) & Sarawak Comparatively more affordable registrations fee

Personalise visits
Identify new sites Meeting KOLs Engaging private hospital, Melaka, Kuala Lumpur & Penang in Oncology, cardio & Psychiatry

Contract management
1. (i) Clinical Trial Agreement, review (ii) Clinical Trial Amendment 2. Budget review

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