Please use this identifier to cite or link to this item:
The Development of Contract Research Organizations in Taiwan：Case Study on Clinical Trials Management
CRO (Contract Research Organization)
|Issue Date: ||2009-09-18 09:19:58 (UTC+8)|
The cost of drug research and development has soared during the past years. And this compels pharmaceutical and biotechnology companies to look for new, smarter ways of running their businesses. One of their strategies is trying to accelerate drug development by outsourcing. The size of the outsourcing market for Contract Research Organizations (CROs) is rising. Clinical-trial operations hold over 70% of the revenue in the CRO industry.
Competition in the CRO industry is extremely international in scope. The key issues for the catching-up company or country is to find their own niche. This study goes on to identify and profile the development of clinical trials and the CRO industry in Taiwan. It also seeks to identify ways of showcasing Taiwan as an Asia-Pacific Clinical Trail Service Center.
There are several conclusions from this study:
1. In the value chain of new drug discovery and development, the current status in Taiwan has the potential to join the international market by conducting the clinical trials. In the long term, we should consolidate our basic medical research to pursue the maximum benefit of biotechnology and pharmaceutical industry, and then to enhance the capability of CRO in Taiwan.
2. The policy for improving industry must be set up after the explicit acting plans, goals and time schedule. It should go through with management, not just a structure or concept. We have to hasten the communication between industry and government. The medical legal authorities need to be more active. Ultimate integration of the functions of the related government departments is exceedingly important.
3. The National Health Insurance (NHI) system covers all of the medical resources in Taiwan, but it lack for the incentive to encourage the medical research. It is recommended that NHI Program should probe into the impact of the biotechnology and pharmaceutical industry, and then try to revise it with more positive thinking.
4. It is very important for Taiwan to improve the professional in clinical trials. Setting up a training center funded by both government and industries is strongly recommended. The organization will have the definite goals and accountability, and provide practical training and systematic continuing education.
5. We need more regulating operations of clinical trials of hospitals in Taiwan. These operations should include the usage of the fees from sponsors, and the rights and responsibilities of all staff. We should set up a transparent standard and obviously encourage a mechanism to enhance the motivation of physicians and hospitals to participate in clinical trials. Hospitals should be encouraged to establish an independent office for clinical trials to perform all the details. This office will promote the interaction within the industries.
1.Ann Neuer, Barry Miskin “QA for the Investigative Site: Building the right foundation is critical to success. Here's how to lay the groundwork for excellence.” Applied Clinical Trials, Nov 1, 2004.
2.Applied Clinical Trials , “Education and training directory: A full listing of college and university courses, training classes, and other educational opportunities.” Applied Clinical Trials, Dec 1, 2004.
3.Applied Clinical Trials , “Internet Resources: The following Web sites are focused on the professional and/or potential participant in clinical trials.” Applied Clinical Trials, Dec 1, 2004.
4.CenterWatch , “CRO Market” CenterWatch, Vol.10, Issue 9, Sep, 2003, p.9-11
5.Contract Pharma , “Top 15 CROs For Fiscal 2003”, Contract Pharma, May 2004, p.38
6.Contract Pharma, “Now that Quintiles is going private, what’s next?” Contract Pharma Autumn Concerns, Sept 2003, p.28
7.David Cavalla “The extended pharmaceutical enterprise.” Drug Discovery Today, Vol.8(6), March 2003. p.267-274
8.Diana L. Anderson, “The Patient Recruitment Market” Applied Clinical Trials, Nov 2, 2003.
9.DiMasi JA, Hansen RW, Grabowski HG, “The Price of Innovation: New Estimates of Drug□Development Costs.” Journal of Health Economics, 2003, Vol 22, p.151–185.
10.DiMasi JA, Hansen RW, Grabowski HG, Lasagna L., “Cost of innovation in the pharmaceutical industry.” Journal of Health Economics, 1991, Vol 10, p.107-142
11.Evan Gothard “Understanding Cost Drivers: Lessons Learned from Multiple Perspectives” Quintiles Presentations, 2002
12.Faiz Kermani and Rebecca Gittins, “Finding the Next Asian Pharma Sensation” Contract Pharma, May 2004, p.54-59
13.Food and Drug Administration. “CDER 2003 Report to the Nation: Improving Public Health Through Human Drugs”. Rockville, Maryland, 20857. 2004
14.Food and Drug Administration. “Challenge and Opportunity on the Critical Path to New Medical Products.” March 2004.
15.Food and Drug Administration. “FDA Announces Standard Format That Drug Sponsors Can Use to Submit Human Drug Clinical Trial Data.” July 2004.
16.Frost & Sullivan “CRO industry coming under pressure,” (part of F&S’ Pharmaceuticals Monitor Service) 2003
17.Graham Hughes, “The CRO Scene in 2003—A Brief Tour.” European Pharmaceutical Contractor, Summer 2004, p.8-10
18.Hansen RW, “The pharmaceutical development process: estimate of current development costs and times and the effect of regulatory changes.” 1979, Lexington Books, Lexington, MA, p.151-187.
19.Janice M. Reichert, “Trends in development and approval times for new therapeutics in the united states.” Drug Discovery, Sep 2003, Vol 2, p.695-702.
20.Jill Weschler, “Clinical Trial Listings and Results Go Public” Applied Clinical Trials, Oct 1, 2004.
21.Kathleen B. Drennan, “Patient recruitment: the costly and growing bottleneck in drug development” Drug Discovery Today, February 1 2002, Vol 7, Issue 3, P.167-170.
22.Kenneth A. Getz and John R. Vogel, "Achieving Results with CROs: Their Evolving Role in Clinical Development," Applied Clinical Trials, April 1995, 32-38.
23.Mary Jo Lamberti, “Going Global” Applied Clinical Trials, Jun 1, 2004
24.Michael A. Martorell, “Consolidation in Outsourcing, A look back at 2003 and a look ahead to 2004,” Contract Pharma, Jan 2004.
25.OPPI—Monitor Group Collaboration, “Outsourcing Opportunities in Indian Pharmaceutical Industry.” Sep, 2003.
26.Peter Lissinger, “Outsourcing: Do it Well or Not at All,” Drug Discovery & Development, March 2004, Vol.7 Issue 3, P.15
27.Philip J. Holt, James E. Lodge, “Merging Collaboration and Technology: The Virtual Research Organization” Applied Clinical Trials, Oct 1, 2003.
28.Richard A. Retting, “The Industrialization of Clinical Research,” Health Affairs 19, no.2 (2000): 129-146
29.Sarah W. Madley, “Snapshot: The CRO Industry Today, Industry strengthens relationships with sponsors, learns the benefits of flexibility and moves more trials out of the developed world.” Contract Pharma, May 2004, Vol 6, No. 4, p.40-47
30.Simon Frantz, “Why are clinical costs so high?” Nature reviews drug discovery, Nov 2003, Vol 2, p.851-852
31.Solomon Nwaka and Robert G. Ridley, “Virtual drug discovery and development for neglected diseases through public—private partnerships.” Nature Review Drug Discovery, Nov. 2003, Vol 2, p.919-928
32.Steven Heffne, “Beyond The CRO : Other players search for their slice of the drug development pie.” Contract Pharma, 2004.03
33.Terumasa Hirai, “Communication between the sponsor and CRO - The contract laboratory perspective” The Quality Assurance Journal, June 1998, Vol 3, Issue 2, P.51-55.
34.The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , “The Value and Benefits of ICH to Industry” 2000
35.Toby Jane Hindin, “Looking Back, Moving Forward: A CRO Retrospective”, Applied Clinical Trials, Aug 2, 2004
36.V.E.K.M. van de Walle “CRO—SMO: Partners in Business or Business Partners?” Monitor, Spring 2002, p.25-28
1.Applied Clinical Trials, http://www.actmagazine.com/appliedclinicaltrials/
2.Contract Pharma, http://www.contractpharma.com/
3.PhRMA, “Updated Principles For Conduct Of Clinical Trials And Communication Of Clinical Trial Results,” http://www.phrma.org/mediaroom/press/releases/30.06.2004.427.cfm
4.Quintiles Transnational Corp., Form 10-K (http://www.quintiles.com) Dec. 2003
5.R&D Directions Staff, “Prospects are good.” http://www.rddirections.com/magazines/randd/view.cfm?articleID=1279
6.The U.S. Food and Drug Administration (FDA) website, http://www.fda.gov
7.TheStreet.com, “Cashing in on privatization,” http://www.thestreet.com/markets/rebeccabyrne/10088838.html
8.Triangle Business Journal, “In depth: largest triangle deals of 2003,” http://www.bizjournals.com/triangle/stories/2004/02/09/focus1.html
9.Trimanos Corp. website, http://trimanos.com/resources/stakehoders/index.html
10.Tufts Center for the Study of Drug Development ,http://csdd.tufts.edu/
|Source URI: ||http://thesis.lib.nccu.edu.tw/record/#G0090359026|
|Data Type: ||thesis|
|Appears in Collections:||[科技管理研究所] 學位論文|
All items in 政大典藏 are protected by copyright, with all rights reserved.