1© Roche 2012.

ANZ Clinical trials – what is the future?

21st March, 2013Dr Dan Thurley MDMedical Director Australia & Asia Pacific, Roche

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2© Roche 2012.

7th September, 2012

A recent decrease in the number of new studiesIn 2012: Australia 18,000 vs Poland 34,000 participants to trials

WHY WORRY SO MUCH ABOUT AUSTRALIAN COMPETITIVENESS?CLINICAL TRIAL APPROVALS IN SINGAPORE, HONG KONG & TAIWAN

Singapore

TaiwanHong Kong

KEY FOCUS AREAS FOR GLOBAL COMPETITIVENESS – AUSTRALIA

Speed to start trials ethics and governance approval times

Subject recruitment productivity and efficiency

Value and cost total cost per patient visit (incl. internal and external costs)

Quality medical and scientific excellence research standards

2012 SURVEY OF RESEARCH GOVERNANCE TIMELINES IN AUSTRALIA

Methodology• Survey sent to 45 commercial sponsors of clinical research in Australia• Data collected on studies commenced in Australia between 1 July 2011 - and 30 June 2012.

Data Collected

Milestone dates:• HREC approval• Last signature date on contract• CTN certification dates:

• principal investigator• HREC• approving authority• sponsor

19 companies responded, providing complete data on 271 CT sites (105 trials).

0

50

100

150

200

250

300

350

400

VIC NSW QLD SA WA TAS ACT

Cale

ndar

Day

s

60 calendar days

HREC Approval (HREC Approval Letter) to SSA Completion (Last Contract Signature)Calendar Days

Best Practice Threshold – 30 calendar days

SPEED: 2012 SURVEY OF RESEARCH GOVERNANCE TIMELINES IN AUSTRALIA

COST: High cost of Australian research

9© Roche 2012.

Roche data: High cost of Australia research

Site State No. Contract Subjects Site Start Up fees [AUD]1 Vic 10 $4,9002 Vic 20 $17,1623 NSW 40 $8,2504 Vic 20 $41,4185 Vic 15 $25,2506 NSW 20 $12,7507 WA 20 $6,6008 NSW 20 $8,6509 Vic 20 $11,900

10 Vic 15 $13,05011 Vic 15 $32,12512 Vic 20 $33,31513 Vic 20 $11,91714 Vic 20 $15,64015 WA 40 $40,05016 NSW 15 $7,95017 NSW 40 $26,25018 Vic 20 $8,98219 Vic 20 $27,88020 Vic 20 $39,11021 SA 20 $20,30022 Vic 20 $24,050

Total $437,499

COST

13© Roche 2012.

“A PLAN FOR AUSTRALIAN JOBS”

• Government’s Industry and Innovation Statement 18 Feb, 2013

• Joint Announcement by Ministers Plibersek and Combet

• One Focus on implementing the CTAG recommendations

• $9.9m funding “expediting clinical trial reform”

14© Roche 2012.

“A PLAN FOR AUSTRALIAN JOBS”

• Creating standardised costs for items used by the clinical trials community

• Incorporating clinical research needs into the e-Health system

• Developing a conceptual design to enable clinical trials to link, on-site and remotely, with medical records of clinical trial participants

• A pilot project to develop a national interactive Clinical Trials Portal

• Education and training of staff and researchers to improve clinical trial conduct and timeliness of approvals

• Enhancing the ability of the NHMRC to work with states, territories and other stakeholders on a nationally consistent approach to clinical trials.

KEY FOCUS AREAS FOR GLOBAL COMPETITIVENESS – AUSTRALIA

Speed to start trials ethics and governance approval times

Subject recruitment productivity and efficiency

Value and cost total cost per patient visit (incl. internal and external costs)

Quality medical and scientific excellence research standards