Malaysia’s ISR Statistics 2016

CRM is entrusted to compile and track the number of ISRs in Malaysia from the Medical Research and Ethics Committee (MREC) and all Institutional Review Boards/ Independent Ethics Committees (IRB/IECs) and these numbers are reported annually to the Malaysian government. Between 2012 and 2015, Malaysia has seen a steady increase in the number of Industry Sponsored Research (ISR) from 179 trials to 201 trials. From 2014 onwards, there was a global decline (by 10%) in the number of ISR recorded and this was re ected in the lower number of ISRs coming into Malaysia during this time period.

Number of ISR Achieved

A total of 162 new industry sponsored research (ISR) was recorded in Malaysia, translating to a 105% achievement of KPI 1 in 2016. KPI 1 is the number of ISR approved by the Medical Research and Ethics Committee (MREC) and 12 Institutional Review Boards (IRBs) across the country.

Note: KPI 1 was imposed on CRM upon its inception in 2012.

Classification of Trials approved by Ethics Commitees in 2016 by Intervention Type (n=162)

Interventional trials comprise the majority of ISRs conducted in 2016, followed by Bioavailability/Bioequivalence (BA/BE) studies and observational/non-interventional studies.

No. of Trials approved by Ethics Commitees in Malaysia in 2016 according to Therapeutic Area (n=162)

By therapeutic area, cardiology trials accounted for the highest number of trials with a total of 18 studies. Oncology trials came up close with 17 trials followed by endocrinology and Pulmonary/Respiratory trials.

No. of Approved Trials at Ministry of Health Sites According to State in 2016

Sarawak recorded the highest number of newly approved trials in 2016 38 approved trials. Meanwhile, Selangor had 29 approved trials.

Note: For multicenter trials, the same trial can be conducted at different sites with different principal investigators.

Number of Trials Approved in 2016 According to Phases

Note: BABE studies and observational trials without phases are excluded from the chart above.

Top 10 Ministry of Health Sites with the Most Industry Sponsored Research Trials in 2016

Note: For multicenter trials, the same trial can be conducted at different sites with different principal investigators.

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