References
- Karlberg JPE. The establishment of emerging trial regions. Clinical Trial Magnifier. 2011;4(1):7–23.
- PricewaterhouseCoopers (2010) – Trends in Asia Clinical Outsourcing.
- Karlberg JPE. Asia clinical trial trends by type of sponsor, trial phase, disease area and country. Clinical Trial Magnifier. 2011;4(2):53–68.
- Price Waterhouse Coopers. The Changing Dynamics of Pharma Outsourcing in Asia: Are You Readjusting Your Sights? 2008. Available from: http://www.pwc.be/en/pharma/the-changing-dynamics-of-pharma-outsourcing-in-asia.pdf. Accessed September 18, 2013.
- Applied Clinical Trials Online. Conducting clinical trials in Asia [homepage on the Internet]. Iselin, NJ: Advanstar Communications; 2013. Available from: http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=334577. Accessed September 18, 2013.
- Wong E. Clinical trials in Southeast Asia: an update. Drug Inf J. 2009;43(1):57–61.
- Saw C, Shogan J. Frontiers of cancer care in Asia-Pacific Region. Biomed Imaging Interv J. 2008;4(3):e45.
- Pharma IQ. Will Asia become the global hub for oncology clinical trials? [homepage on the Internet]. London, UK: 2011. Available from: http://www.pharma-iq.com/clinical/articles/will-asia-become-the-global-hub-for-oncology-clini/#.UVDuLjfeBU4. Accessed September 18, 2013.
- Iwasaki M, Hinotsu S, Katsura J. Clinical trials and approvals of anti-cancer agents. Jpn J Clin Oncol. 2010;40(Suppl 1):i65–i69.
- Prabhakar VR. Global Clinical Trials in Asia: Challenges and Opportunities. Horsham, PA: Drug Information Association; 2010. Available from: http://www.diahome.org/productfiles/22993/day3/402/s402 01_vijay prabhakar.pdf. Accessed September 18, 2013.
- DAVA Oncology. Patient Recruitment in Cancer Clinical Trials. A DAVA Oncology White Paper. DAVA Oncology: Dallas, TX; 2012. Available from: http://www.davaonc.com/assets/pdf/DIA2012White Paper.pdf. Accessed September 18, 2013.
- Hartmann M. Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries. Trials. 2012;13:53.
- Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nature Rev Drug Discov. 2008;7(1):13–14.
- Getz KA. Global clinical trial activity in the details [homepage on the Internet]. Iselin, NJ: Applied Clinical Trials Online; 2007. Available from: http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=453243&sk=&date=&pageID=3&searchStrin=globaltrials. Accessed September 18, 2013.
- Mills I. Productive Partnering – The Next Stage in Patient Recruitment for Clinical Trials. Sausalito, CA: Caribou Publishing; 2008. Available from: http://obroncology.com/documents/OBR_nov08_PP.pdf. Accessed September 18, 2013.
- US Food and Drug Administration. Guidance for Industry, Investigator Responsibilties – Protecting the Rights, Safety, and Welfare of Study Subjects. Silver Spring, MD: US Department of Health and Human Services; 2009. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf. Accessed September 18, 2013.
- Schulz G. Clinical trial in Asia: opportunities and challenges [homepage on the Internet]. Wanchai, Hong Kong: Zuellig Pharma Asia Pacific Ltd; 2012. Available from: http://www.zuelligpharma.com/news/clinical-trial-asia-opportunities-and-challenges. Accessed September 18, 2013.
- Baer AR, Bridges KD, O’Dwyer M, Ostroff J, Yasko J. Clinical research site infrastructure and efficiency. J Oncol Pract. 2010;6(5):249–252.
- Alsumidaie M. How has bureaucracy affected clinical trials? [homepage on the Internet]. New York, NY: Annex Clinical; 2011. Available at: http://www.annexclinical.com/annexpost/blog11.21.12. Accessed September 18, 2013.
- Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials. 2006;3(6):496–502.
- Engineer F, Tharmaratnam A. Realizing the Promise of Asia-Pacific: The Region’s Strategic Shift from Outsourcing to Innovation. Durham, NC: Quintiles; 2010. Available from: http://www.quintiles.com/assets/0/111/118/233/1336/f28b5d15-531a-4d91-88a2-058d9ea451b1.pdf. Accessed September 18, 2013.
- Nuttall A. Considerations for Improving Patient Recruitment into Clinical Trials. San Francisco, CA: RDP Clinical Outsourcing; 2012. Available from: http://www.rdpclinical.com/pdfs/RDP_Recruitment_Whitepaper_23Mar12.pdf. Accessed September 18, 2013.
- Bhatt A. Quality of clinical trials: A moving target. Perspect Clin Res. 2011;2(4):124–128.