Location for Trials- Global Considerations A Pharma Perspective Carlo Maccarrone Assoc. Director, Clinical Research GSK Australia 7 May 2014
Why Choose Australia for Clinical Trials? What is he saying to the Global R&D Head of a Multi-National Pharmaceutical Company? 30 seconds elevator speech? Top 3 reasons? Presentation title in footer 00 Month 0000 2
Why Choose Australia for Clinical Trials? Feedback? What s Ideal? Presentation title in footer 00 Month 0000 3
Feedback from Workshop Members - Verbatim Not in any order of priority Cultural diversity Good clean data Quality sites with attention to detail Good quality healthcare therefore accurate safety data Tax incentives Highly trained Study coordinators Key opinion leaders / experts Engaging participants Standard of care Can exploit frontier technologies based on research in Aus Medicines Australia standard contracts Single country many states Sound governance practice Simple regulation High quality health facilities / infrastructure We can do the nightshift Seasonal disease Because of good basic healthcare no issue with study participants Strong clinical networks CTN scheme Sophisticated technology for complex studies English speaking Presentation title in footer 00 Month 0000 Less likely for controversy 4
IMPORTANCE OF INDUSTRY-SPONSORED CLINICAL TRIALS The Australian Medicines Industry invests over $650 million in clinical trials per year....benefits for Australian patients, healthcare system, researchers and the Medicines Industry
A Patient Perspective Access to better treatment options & Quality of life
CLINICAL TRIALS IN AUSTRALIA KEY FACTS The Australian Medicines Industry conducts clinical trials in over 30 therapeutic areas. Each year, more than 18,000 Australians participate in these trials. Top Five Areas of Clinical Trial Activity in Australia Source: Inaugural Survey of Investigator Perception on the Value of Industry Funded Clinical Research, 2009
CLINICAL TRIALS IN AUSTRALIA KEY FACTS In 2010 alone, the Australian Medicines Industry invested over $600 million on clinical trials. That is more than 10 times as much as the National Health & Medical Research Council spent on clinical trials. Collectively, early stage research accounts for around 40% of the industry s total investment. $625,437,718 Private Investment in Clinical Research - 2010 $295,034,818 (48%) $137,885,239 (22%) $29,465,915 (5%) $87,604,498 (14%) $49,446,798 (8%) $12,266,450 (2%) Total Pre-Clinical Phase I/Stage I Phase II/Stage II Phase III/Stage III Phase IV IIT Source: 2011 Survey of Australian Clinical Research Activity, Department of Innovation, Industry, Science, Research and Tertiary Education and the Pharmaceuticals Industry Council
CLINICAL TRIALS IN AUSTRALIA KEY FACTS Eighty percent of industry-sponsored clinical trials in Australia are conducted in New South Wales, Victoria and Queensland, mostly at public hospitals, universities and private research institutes. Source: 2010 Benchmarking Survey of Australian Clinical Research Activity, Pharmaceuticals Industry Council
Challenges: R&D Cost & Productivity Key facts about R&D Rising Cost of developing a new drug: ~$1.4 billion Time to market: 10-15 years Low R&D productivity: 5,000 10,000 potential new compounds screened to get one medicine to the market ROI: Only three out of ten marketed drugs produce revenues that match or exceed average R&D costs
Challenges: R&D Productivity (global) Source: PhRMA,2012 profile, Total R&D includes domestic and R&D abroad, PhRMA members companies, various years; FDA, CDER new molecular entity and new biologic approval reports available at http://www.fda.gov.
Global Clinical Trials: Factors Impacting Country Selection: Ethical & Social Considerations Quality & Availability of Research Staff Market Attractiveness & Relevance Disease Prevalence & Standards of Care Monitoring Resource Availability Competitive Landscape Location, Location, Location HREC /Gov ce & Regulatory Environment Clinical Research Economics
Shifting Pendulum of Clinical Research: Percentage of Subjects Randomized by Region for Industry Cohort, 2000 vs. 2007 EU Non-Core 8% > 21% EU Accession 4% > 8% EU Core 21% > 12% Drivers: Access to patients Cost -efficient Global data package Govt investment Market growth North America 41% > 36% Asia Pacific 2% > 10% Latin America 3% > 7% Middle East & Africa 2% > 3% Centre for Medicines Research. CMR, a Thomson Reuters business.
Global medicines market
CLINICAL TRIAL ACTIVITY DECLINED BY 12% BETWEEN 2007 AND 2012. AMENDED DATA FROM TGA JULY 2013 Number of New Clinical Trials Number of New Clinical Trials - 1H Number of New Clinical Trials - 2H Number of New Clinical Trials - Full Year 865 705 318 539 314 740 360 559 296 601 603 282 281 685 676 403 346 741 398 481 748 428 693 355 634 327 679 350 759 416 387 225 380 263 319 322 282 330 343 384 320 338 307 329 343 326 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Calendar Year Source: Therapeutic Goods Administration Half-Yearly Perforrmance Reports, Clinical Trials (Medicines)
Key focus areas for global competitiveness Speed to start trials Ethics and governance approval times Participant recruitment Productivity and efficiency Value and cost Total cost per patient visit (incl. internal and external costs) Quality Medical and scientific excellence Research standards
Speed to Start Subtitle here
2009 PIC RDTF Benchmarking Data Multinational Corporations* Compared to your company s global average, the time taken to complete study startup in Australia is: Same 48% Timeliness Faster 13% Much Faster 0% 0-3 Months 9% On average, study start-up for ALL sites (from receipt of final protocol to first patient visit) 3-4 Months 39% Slower 30% Much Slower 9% Longer 30% 4-6 Months 22% - 39% companies report Australia slower or much slower than global average for time to start trials -30% report start-up time >6 months * n = 23
Calendar Days 2012 SURVEY OF RESEARCH GOVERNANCE TIMELINES IN AUSTRALIA HREC Approval (HREC Approval Letter) to SSA Completion (Last Contract Signature) Calendar Days 400 350 N=271 sites (105 trials) 300 250 200 150 100 25th ile (8 days) Median (33 days) 75th ile (66 days) 50 0 VIC NSW QLD SA WA TAS ACT
2012 SURVEY OF RESEARCH GOVERNANCE TIMELINES IN AUSTRALIA HREC Approval to SSA Approval (Study X Multi-Centre Clinical Trial 15 sites) Calendar Days 79 71 63 65 61 42 36 25 20 24 23 6 10 1 1 VIC-1 VIC-2 VIC-3 VIC-4 VIC-5 VIC-6 VIC-7 NSW-1 NSW-2 NSW-3 NSW-4 QLD-1* SA-1 SA-2 SA-3
Subject Recruitment Subtitle here
2009 PIC RDTF Benchmarking Data Multinational Corporations* On Par 38% Capacity - Subject Recruitment In 2008, was your company s average patient recruitment rate below, on par or above your company s global average? Phase III Above 19% N/A 5% On average, how often do you meet this target (i.e., what is your patient recruitment rate?) 80-100% 45% Phase III 0%-50% 0% Below 38% - Recruitment challenges are specially acute for Phase III trials 38% reported that the Australian company s average patient recruitment rate was below the company s global average for Phase III trials - More than half reported that they meet recruitment targets between only 50% to 80% for Phase III trials 50-80% 55% * n = 23
Clinical Trial Costs Subtitle here
AUSTRALIA IS ONE OF THE MORE EXPENSIVE COUNTRIES IN WHICH TO CONDUCT CLINICAL TRIALS, A SITUATION MADE WORSE DUE TO THE SIGNIFICANT VARIABILITY IN WHAT INDIVIDUAL RESEARCH SITES CHARGE FOR PERFORMING VIRTUALLY IDENTICAL TASKS.
Key focus areas for global competitiveness... 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
Clinical Trial Initiatives Australia Subtitle here
Clinical Trial Initiatives National Clinical Trial Action Group Report (CTAG) (Mar 2011) Clinical Trial Advisory Committee (CTAC) (April 2014) $9.9 M funding allocation to expedite clinical trial reform Feb 2013 Mutual Acceptance HREC review (MOU) - VIC, NSW, Q ld, SA - 85% CTs McKeon Strategic Review of Health & Medical Research (2013) ARCS workshops on HREC/ Governance NHMRC Clinical Trial Research Governance Meetings - Sep13 & Dec 2013 ehealth Workshop 2012 (PIC RDTF) Patient Information Brochure (CHF / NHMRC)) Creation of www.australianclinicaltrials.gov.au website IHPA Report Schedule of standard costs for Clinical Trials cost-recovery of efficient clinical trials further work needed
Standing Council on Health - COMMUNIQUÉ 11 April 2014 Australian Health Ministers met in Brisbane today for a meeting of the Standing Council on Health (SCoH). The meeting was chaired by Jillian Skinner, NSW Minister for Health and Minister for Medical Research Multi-jurisdiction clinical trials Ministers endorsed work to identify ways to enhance clinical trial activity in Australia by implementing a national approach to clinical trials. They agreed to ask the Australian Health Ministers Advisory Council to conduct a scoping exercise, in consultation with the National Health and Medical Research Council, to report back on practical approaches to enhancing clinical trials activity
Clinical Trial Initiatives Industry Subtitle here
Efficiency Enhancing Collaboration in Clinical Trials To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies. http://www.transceleratebiopharmainc.com/
Why Choose Australia for Clinical Trials? Top 3 reasons? Presentation title in footer 00 Month 0000 31
Australian Clinical Research - Differentiators CTN Regulatory process Fast to First Patient (can be) Medical & Scientific Excellence World-leading Experts across many therapy areas Respiratory, Oncology, Cardiovascular, Diabetes, HIV etc Early Phase, Proof-of-Concept, Complex Trials Quality Framework Patient Care, Medical Infrastructure, Ethical framework Experienced & well educated workforce can do attitude
Minister for Health, Peter Dutton s address to the George Institute for Global Health 1 May 2014 Australia is also a world leader in the conduct of clinical trials and I acknowledge the George Institute s role in this area. Clinical trials provide vital evidence that leads to better outcomes for patients and often save money for health providers. Improving support around and access to clinical trials is a priority for the Government and I am working with my State colleagues on this issue particularly around cutting down the regulatory burden and cost, while embedding trials in clinical practice in the hospital system. We need to ensure that trials in this country remain internationally competitive. It should be our goal to make Australia the number one destination for clinical trials. This is the kind of industry we need as a nation providing high-value jobs for Australians, allowing us to retain our talented scientists and attracting outstanding individuals from overseas. It has great potential for continued expansion creating more local jobs in manufacturing, and increasing our export earnings. It s also vital that we stimulate investment for translational research, to use research results in treatments and clinical practice.
Thank you carlo.x.maccarrone@gsk.com