Analysis of Competitiveness & Cost-Effectiveness for Clinical Trial Host Country Selection

1. Analysis of Current Competitiveness and Cost-Effectiveness to Select the Host Country for a Clinical TrialNameInstitutional Affiliation

2. Introduction • In modern society, drug companies face challenges in conducting new clinical trials (Biehl, 2006). • The amount of drugs entering global market has reduced. • Cost of clinical trials have escalated, R&D productivity slipping (Piachaud, 2002). • Therefore, there is increased need for cost-effective clinical trials • Countries are making efforts to provide the best environment for clinical trials leading to global competition.

3. Offshoring Clinical Trials • Clinical trials are proven procedures of drug innovation (Piachaud, 2002). • Most clinical trial companies include biotechnology and pharmaceutical industries, hospitals, governments, ad research institutions (Boggs and Bayuk, 2009). • Clinical trial research promotes positive health outcomes significant for economic and social benefits. • Trials include screening, early treatment, improved medical procedures, and clinical management (Thakur & Rutgers University, 2010).

4. Offshoring Clinical Trials Cont… • Most pharmaceutical companies have marginalized drug development procedures leading to seeking of new locations (Maiti & Raghavendra, 2007). • Most clinical research is based on ethical and regulatory frameworks. • Therefore, there is increased competitiveness and desire to conduct cost-effective trials (Petryna, 2009). • CROs development has promoted procedures of locating research site and other activities for cost-effectiveness. • CROs development has led to new trend in clinical research (Lamb & Setley, 2005).

5. Major Countries Leading in Clinical trials • United States with $64 million investment • Asia • United Kingdom • Belgium • Rest of the World (RoW) countries with 6500 sites (Gross & Hirose, 2007) • India with 40-50 % lower than developed nations • China, Eastern and Central Europe, and South America are also emerging markets for clinical trials representing 36 % patient enrolment (European Commission, 2011).

6. Advantages and disadvantage of Clinical Trials in Leading Nations • UK has barriers of unfavorable national regulations and legislation, lack of GCP. • Advantages include R&D investments, website development (Thiers, 2008). • Netherlands barriers include; unattractive legislation and long approval times • Netherlands key strengths include; robust patient information systems clinical trial agreements, insurance standardization, and good economy (Medicines Australia, 2011).

7. Advantages and disadvantage of Clinical Trials in Leading Nations • Barriers of France includes, high number of clinical trial specialists, human resources to support investigators and short approval times • Challenges in France includes, high taxation on pharmaceutical products, neglect of small institutions • Australia strengths includes, strong R&D estimated at $29.5 billion, high quality infrastructure, ethically diverse population (PWC, 2012). • Weaknesses in Australia includes, geographically dispersed population and expensive Phase II and III trials

8. Factors to Consider When Selecting a Host Country for Clinical Trials Technological Development • Pharmaceutical companies consider level of technology (Marks and Power, 2002) • Investment in website • Technological stakeholder initiatives (Patel and Vega, 1999) • Online networks • Digitalized clinical trials that offers patients with fast and easy to use information • Online participation and tools of decision support that facilitate process of informed consent (McKelvey & Orsenigo, 2002)

9. Research Infrastructure and Human Resource • clinical trials are based on the high-quality input to research methodology (Archibugi and Pietrobelli, 2003). • Existence of clinical trial units that provide advice and support for design and analysis of clinical results. • A strong expertise capacity in disease outbreak areas (Patel & Vega, 2009). • Establishment of a public interest group to merge private and public clinical research stakeholders. • Specialist research centers • Training and education support (World Health Organization, 2013).

10. Improved Ethics in Clinical Research Trials • main issues raised included the standard of care, reasonable availability, and the quality of informed consent (McAdam, 2004). • Absence of controversies on ethical issues • Existing ethical framework of a host nation • Reduced levels of exploitation of research subjects (Schüklenk, 2000). • Presence of developed partnerships with the markers of health policies, researchers, and the community (Kazdin, 2003). • Involvement in partnerships in sharing responsibilities

11. Improved Ethics in Clinical Research Trials • Recognition of social value when selecting a host country for clinical trials (Levine, 2009). • Streamlined governance and ethics processes • Presence of developed individual centralized ethical review processes. • Jurisdictions on ethical reviews • Reviewing and monitoring clinical research trials • Established codes of conducting ethical clinical trials (Tal, 2011).

12. Clinical Grant Development • Clinical grants bolster the credibility of CROs • Support given by host country to clinical trials (Lead Discovery, 2006). • Existence of medical research charities. • Offers on medical research grant charities to strengthen and support their research base. • Development of UK Clinical Research Network and building of internal expert research workforce (PWC, 2012). • Presence of constituted of dedicated and highly trained research staff in the healthcare

13. Clinical Grant Development • Presence of research grant programs • Contribution by funding investigator-initiated and non-pharmaceutical trials (World Health Organization, 2013). • Clinical trial grants provide the additional support necessary for maintaining the quality of human capital • Provision of grants to hospitals • Funding of pilot studies (Reichert, 2003).

14. Growing Pressure of R&D Spend • Increased Investment in R & D • Economic development of the host country • Return on revenue of pharmaceuticals (Roux, Pratt and Tengs, 2008). • Enhanced financial regulations • Drug prices • Existence of social security funds (PWC, 2012). • Better percentage of the budgetary financial allocations • Percentage share of total R & D budget used to support clinical trials (Petryna, 2009).

15. Growing Pressure of R&D Spend cont.… • Budgetary allocation favorable for competitive clinical trials • Presence of a flexible framework based on ‘live licensing’ approach (Brown, Dunn & Butow, 2008). • Introduction of R & D Tax Credit in various phases of clinical trials, such an in Australia • Technological adjustment of R&D positions. • Level of internationalization and globalization of R&D-specific factors (Gattellari & MacLeod, 1999). • Degree of cooperation between R & D units • formulation of a clear strategic plan to promote clinical trials (Ellis, Dowsett & Tattersall, 1999).

16. Promoting Clinical Trials • Offers competitiveness and cost effectiveness of clinical trial initiatives • There are current challenges stemming from clinical trial environments (Butow, Brindle and McConnell,1998). • Future environment presents better opportunities. • Emergence of evidence-based medicine promotes data gathering in clinical development and practice (Antonakis, 2001). • Development of ‘live licensing’ ensures continuous post-approval data gathered.

17. Promoting Clinical Trials cont.… • Requires increased emphasis on traditional research • Current professionalism in research centers promotes clinical trials (Thakur & Rutgers University, 2010). • Existence of health economic data leads to transparent clinical trial activities. • Biobanking would increase competitiveness and cost-effectiveness. • Patient empowerment increases transparent clinical trials (Hrobjartsson & Gotzsche, 2001). • Increased patient access to clinical trials ensures competitiveness and cost-effectiveness.

18. Promoting Clinical Trials cont.… • Revising and streamlining the clinical trial submission in process • development a procedure of co-operation between member states (Valdez-Martinez &Turnbull, 2006) • create a single submission portal regarding clinical trial applications • Upgrading of local clinical trials • Establishment of collaborative models of clinical trials. • Application of public to private partnerships, licensing arrangements, and co-development or outsourcing promotes clinical trials (TheLancet (2007).

19. Promoting Clinical Trials cont.… • Standardization of clinical trials • Better patient recruitment approaches • Centralization of cost-effective trials (Commonwealth of Australia, 2011). • Improving clinical trial environment for further attraction • Integration of networks of specialized centers and high quality expertise. • Promotion of pooling and sharing of best practice and knowledge in clinical trials. • Better consultation among clinical trial stakeholders (Commonwealth of Australia, 2011).

20. Promoting Clinical Trials cont.… • Requires standardization and setting up of ‘one-stop shop’ such as online portal for clinical trial submissions • standardization and harmonizing all the administrative tasks and procedures • Establishment of informed consent forms and procedures of negotiating contract agreements. • localization of favorable clinical trial participants • Support to clinical trials through facilitation to access to innovative drugs, capping the cost and fees that can be charged by clinical sites and investigators • Addressing barrier concerns • Enhancing biobanking regulations

21. Conclusion • There is more to clinical trial than it is anticipated • Clinical trials creates employment, improves health of citizens, and provides revenue returns. • Ensuring selection of a better host country requires informed analysis of various factors including, R&D position, economy, health infrastructure, ethical concerns, and technological developments.

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