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MANAGING CLINICAL TRIALS OUTSIDE OF THE US John Potthoff, PhD President & CEO.

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Presentation on theme: "MANAGING CLINICAL TRIALS OUTSIDE OF THE US John Potthoff, PhD President & CEO."— Presentation transcript:

1 MANAGING CLINICAL TRIALS OUTSIDE OF THE US John Potthoff, PhD President & CEO

2 Theorem Clinical Research Global, full-service CRO employees Planning and execution of clinical trials and regulatory applications Focused business units: Medical Device and Diagnostics BioPharmaceutical Development Clinical Analytics Coverage of 44 countries Page 2

3 Why conduct trials outside of the US? Page 3 Gain registration in target company Support a global development effort Complex or rare diseases; incident rates may not be high enough in the US to enroll a trial Timelines for registration may be faster outside of the US to allow a company to begin sales while completing registration in the US Costs may be reduced for registration outside of the US Competitive landscape may be advantageous outside the US

4 Where are trials conducted? Page 4 Data as of 02 December 2012

5 Actively Recruiting Studies Non-U.S. Only (49%) U.S. Only (45%) Both U.S. & Non-U.S. (7%) Location Number of Recruiting Studies and Percentage of Total Non-U.S. Only14,193 (49%) U.S. Only13,010 (45%) Both U.S. & Non-U.S.1,898 (7%) Total29,101 (Data as of December 02, 2012) Page 5

6 Focus on Asia Pacific Page 6 Aging Population Increasing Life Expectancy Increasing Incidence of Major Disease Increasing Health Consciousness Higher Disposable Income Over 30% of new expenditures on healthcare worldwide are attributable to Asia.

7 Why Asia for Clinical trials? Page 7 Money Cost of clinical trials in Asia is much lower than in US/EU (30-50%) Time Start-up timelines have become more favorable (other than China) and are 4-6 months covering all applications, site selection, contract negotiations, etc. Resources Population exceeds 4 billion and is genetically diverse High incidence of some indications: Diabetes Mellitus (> 11%), Hepatitis B, etc. Ability to recruit patient naïve and advanced case patients Seasonality Southeast Asia: Advantage for seasonal indications (e.g. influenza)

8 Regulatory Authorities in Asia Pacific CountryAuthority ChinaSFDA Hong KongDoH AustraliaTGA IndiaDCGI JapanMHLW KoreaKFDA MalaysiaMoH New ZealandMedsafe PhilippinesBFAD SingaporeHSA & AVA TaiwanDoH Page 8

9 Asia Regulatory and Start-up Timelines *Note: China not to scale Complicated and risk of delays Page 9

10 Data Collection in Asia Pacific Page 10 Data Collection Most Trials conducted in accordance with global regulatory guidelines* Virtually all sites conduct clinical research in English Virtually all sites can work in electronic data capture (EDC) systems Most of the leading EDC tools now allow for multi-language data processing, allowing sites to add comments in their local language** *Some local trials conducted according to local minimal guidelines **Requires ability of CRO to process data in local languages

11 Focus on China and India Page 11 *1.3 billion people *537 active trials in oncology (cancer) *102 active medical device trials *1.2 billion people *124 active trials in oncology (cancer) *27 active medical device trials China India

12 Drug Controller General of India (DCGI) Page 12 Currently politicizing on policy issues relating to compensation for injury to or death of a participant in a clinical trial Currently left to the discretion of the Ethics Committee Indication under investigation/cause of injury or death may not be considered Example: Oncology trials often have survival as the outcome measure Unable to conduct first-in- man trials in India Only may conduct trials in India if registration in India is the goal

13 Conclusions Conducting clinical trials outside of the US is a necessary part of reaching a global audience Conducting clinical trials outside of the US can be highly complex without local knowledge and experience Several advantages to conducting trials outside of US: Registration in multiple regions Access to specific patient populations Strategy to seek registration in cost advantaged locations Page 13

14 John Potthoff, PhD President & CEO


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