clinical research impact study in thailand...

Clinical Research Impact Study in Thailand Pharmaceutical Research and Manufacturers Association (PReMA)

July 2016

© 2016 Deloitte Southeast Asia Ltd 2

Purpose of the study

PReMA appointed Deloitte Access Economics to undertake a study to assess the economic and health related benefits of clinical research in Thailand. The purpose of the study was threefold.

Promote and increase awareness of the contribution local clinical research makes

to the Thai economy

Develop recommendations for policy makers and other

stakeholders to better attract clinical research

Identify existing inefficiencies in the industry


Methodology

• PReMA members • Clinical Research

Organisations • Universities

20 surveys, representing 67% response rate amongst member companies (involved with research) Several submitted surveys were populated with inadequate cost data of conducting clinical trials in Thailand

Survey

1 Consultation Desktop

research

2 3

A number of local face to face consultations were conducted:

Discussion focused on the current clinical research environment in Thailand, its challenges, impediments and opportunities

Publicly available information was sought to complement, triangulate and fill gaps identified during the survey and consultation phases Sources included: • Peer reviewed journal articles • ClinicalTrials.gov • Ministry of Public Health • World Health Organization • Thai Clinical Trials Registry

No.

PReMA members 9

CROs 2

MedResNet 2

Universities 7


SWOT analysis

Strengths Weaknesses

Opportunities Threats

• Large naive patient population across many disease profiles

• High cost-effectiveness in hosting trials • High incidence of tropical diseases • Access to state-of-the-art, readily available

medical equipment and facilities infrastructure • Significant presence of research based

pharmaceutical industry and CROs • Increasing density of pharmacists

• Lack of government funding to ease the clinical trial approval process

• Limited number of FDA accredited IECs and FDA approvers

• Mandatory approval processes are run sequentially and not in parallel

• Strategy and policies in clinical research areas are short-term focused

• Limited experience in early stage trials

• Economic growth potential • Potential to attract foreign medical specialists as

demand increases • Increased submission/registration fees to address

government funding gap • Trend of private hospitals entering the clinical

trial research market

• Continued domestic dependency on "value added" rather than "value creation"

• Slow adoption to the trend of collaboration among stakeholders

• Growth potential not scalable with currently available talent

• Increased reliance on effective intellectual property protection


Thailand as a clinical trials provider

Thailand is well equipped to be a strong contender in the international clinical research market.

0

20

40

60

80

100

120

140

160

180

200

2010 2011 2012 2013 2014 2015

Phase 1 Phase 2 Phase 3 Phase 4 Unknown Phase

Number of clinical trials commenced in Thailand, by year and phase

Impressive hospital system High incidence of tropical

diseases

Concentrated patient population

Lower cost than other countries

Over the five years to 2015, the number of newly registered trials on Clinical Trials.gov has steadily increased by around 10% per year to be just under 207,000 now. The number of trials in Asian countries (Taiwan, South Korea, Singapore, Malaysia, Vietnam and The Philippines) has remained relatively constant, averaging around 1400 a year. Thailand has averaged around 160 new registrations on Clinical Trials.gov, with a slight decline over the period


Thailand’s Competitiveness

Levels of clinical trial investment in South Korea, Malaysia and Vietnam have increased in recent years, whilst Thailand has seen a slight decrease in 2015.

Lack of promotion about Thailand’s potential as a provider of clinical trials

Approvals processes are sequential rather than parallel

as in Korea and Taiwan

If regulations were streamlined to be like

competitors’, Thailand’s share of international trials could be

larger

Shortage of scientific professionals

Thailand is an emerging provider of clinical trials in the South East and East Asian region, with only South Korea and Taiwan conducting more studies. However, as a proportion of international research, Thailand is a small player, assuming less than 1% of trial work

Number of trials conducted in East Asia and South East Asia, 2010-2015

Source: ClinicalTrials.gov

Feedback from stakeholders


Economic impact

(7.8 billion) was spent on phase 3 research

฿10.4 Billion was spent on clinical trials in Thailand in

2015

It is estimated that there were 761 clinical trials conducted in

Thailand in 2015 with approximately 111,672

participants

75%

฿3.94 Billion

was spent on trials

sponsored by private industry

฿8.8 Billion

Towards Thailand’s GDP in 2015, or 0.05%

Clinical trials in Thailand contributed ฿6.8 billion directly to GDP, and stimulated an additional ฿2.0 billion in

contributions in upstream industries. This is comparable to the contribution from the manufacturing and repair of scientific equipment (฿8.7 billion, 2010 figures), the production of noodles and similar products (฿8.5 billion)

Economic value of

฿436 Million

from medicines sold

Clinical trials conducted in 2015 are estimated to result in economic value from future medicine sales sufficient to generate a 4.2% rate of return, in net present values

Expenditure

Contribution

All values are in Thai Baht


Impact on the Thai population

Additionally, 6,604 FTEs were employed in industries related to the clinical research sector

111,672 Thai clinical trial participants in 761 trials 8,905 FTEs

directly employed by the industry who were paid ฿4.9 billion in

2015

The majority of 2015 trials were Phase 3, with the smallest number of trials being Phase 1. Similarly, Phase 3 trials had the highest participant numbers, followed by Phase 4


Health benefits

Based on data from the World Health Organisation and Deloitte research, the value of expected health benefits arising from clinical research conducted in

Thailand in 2015 is ฿10.5 billion

The wellbeing or quality of life gains observed across the Thai population over time can be quantified in disability adjusted life years (DALYs), using data from the Global Burden of Diseases, Injuries, and Risk Factors Study (World Health Organisation 2016). An earlier Australian study (Access Economics 2003) estimated that health related medical research directly, indirectly or serendipitously accounted for at least half of the gains in health over time. More recently, the (Australian) Office of the Chief Scientist (2016) attributed 55% of health gains to research. This was made up of 38% directly due to medical research and 17% arising from a contribution to better treatment practices and lifestyle changes. Thailand represents 0.37% of global trials. On this basis, clinical trials conducted in Thailand would be responsible for 8,326 DALYs averted


Cost Benefit Analysis All values are in Thai Baht

A study in Australia in 2008 estimated the benefit to cost ratio of 3.1, from the NHMRC’s (The National Health and Medical Research Council) funded R&D


Key Recommendations

Address regulatory efficiencies to make Thailand more competitive • Increase number of regulators and capacity building programs with international partners • Centralise IRB and approval Boards. • Eliminate customs tariff for medicines used in Clinical Trials • Increase the number of accredited trial sites and skilled workers, particularly outside

Bangkok metropolitan region.

Prioritise policies that promote R&D innovation & clinical research • Coordinate development and implementation of policies across ministries - MOPH, MoST,

MoE, and MoC. • Increase promotion of clinical trial capability of Thailand domestically and overseas • Development of annual clinical research metrics in biopharmaceutical index to measure

progress

Create a multidisciplinary National Clinical Research Task Force to establish a detailed roadmap for the clinical research development in Thailand

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