How to Conduct Clinical Trials in China

Publication Date	April 2008
Publisher	Liang Kong
Product Type	Report
Pages	146
ISBN Number	not applicable
Product Code	LIK00001

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Summary

More and more global trials are coming to China doe to the following reasons in recent years:

China, with 1.4 billion of populations can provide solution to the rapid patients' recruitment process and will result a shorter timeframe for all the global trials.
Next, there has been great awareness on the GCP nowadays than before. More GCP-compliant sites are available for clinical trials and the quality of the sites has also been improved tremendously.
In addition to the effective clinical trial cost, there has also been increasing in the scientific innovation from China, which is attractive to the world.
Interestingly, the government more open and is adjusting its policy in order to be consistent with the international conventions.

China has established its Chinese Traditional Medicine system for thousands of years, and there was no clinical trial at all before the western drug was introduced in China in recent 100 years. China GCP was introduced in 1998 by MOH and its revised version was introduced in 1999 by SDA (called SFDA from 2003).

China has attempted to streamline its regulation and align the country with international standards of practice; as a result, the countrys legal system governing pharmaceutical research, production, and marketing was modified substantially recent years. One of the examples is that the MOH issued the first version of GCP in 1998. After the establishment of the SDA (now SFDA, State Food and Drug Administration), SFDA formally issued its GCP September 1, 1999, after ten years of work, and the latest version of GCP was issued in 2003 after the new Drug Administration Law went into effect in 2001, and the new Drug Registration Procedure went into effect in 2002. Clinical trial activity in China is on the rise. And also in accordance with requirements of the World Trade Organization (WTO).

China is expected to be the fourth largest pharmaceutical market by 2010, and the average growth rate of China market kept more than 15% since 1978, however, to conduct global trial in China is still facing some questions different from other countries. so is it possible to the conduct trials in China? what are the main challenges to conduct trial in China? What are the strategies to conduct trial in China? In addition, if the sponsor would like to select a CRO in China, how to select?

The challenges and strategies to conduct clinical trial in China will be given in this report.

Content

Summary
Session 1 Global Pharmaceutical industry & China
- 1.1 Pharmaceutical industry is still profitable
- 1.2 Pharmaceutical industry gwowing
- 1.2.1 The global market is growing
- 1.2.2 Growth rate is slowing down
- 1.3 R&D
- 1.3.1 R&D Spending/sales revenue
- 1.3.2 R&D Productivity Declining
- 1.3.3 R&D Spending and Productivity for Various U.S. Industries
- 1.3.4 More expensive to develop a new medicine
- 1.4 Strategies
- 1.4.1 Outsourcing increasing greatly in the world
- 1.4.2 M&A
- 1.4.3 Generic Drug
- 1.4.4 To introduce trial into new countries, such as China
- 1.5 More Multinational Clinical Trials
Session 2 Pharmaceutical regulatory environments in China
- 2.1 Basic introduction of China Pharmaceutical industry & multinational companies in China
- 2.2 Laws & regulation
- 2.2.1 Intellectual Property Rights
- 2.2.1.1 Data Exclusivity:
- 2.2.1.2 Patent Linkage
- 2.2.2 Anti-Counterfeiting
- 2.2.3 Pricing
- 2.2.4 Hospital Bidding
- 2.2.5 Reimbursement
- 2.3 SFDA
- 2. 4 Drug Administration Law of the People's Republic of China (2001 Version)
- 2.5 GCP development in China
- 2.6 R&D localization in China
Session 3 GCP status in China
- 3.1 GCP Evolution
- 3.2 China GCP vs ICH-GCP
- 3.3 Questions of GCP implementation
- 3.3.1 Insufficient Understanding of GCP
- 3.3.2 Informed Consent Forms
- 3.4 Differences in Implementing GCP
- 3.5 Measures being taken or to be taken
- 3.6 Summary
Session 4 Opportunities to conduct clinical trials in China
- 4.1 More Multinational trials in China
- 4.2 Reasons to conduct multinational clinical trials in China:
- 4.2.1 Future marketing in China
- 4.2.2 Fast patient recruitment
- 4.2.3 Broad Disease Profile
- 4.2.4 GCP compliance site
- 4.2.5 Increasing scientific innovation from China
- 4.2.6 Low cost
- 4.2.7 Government Policy Adjustment
- 4.2.8 FDA acceptance
- 4.2.9 Shortening the time to market a new drug
- 4.3 China: the most appropriate place to conduct trials apart from US
- 4.5 Conclusion
Session 5 Challenges to conduct clinical trials in China
- 5.1 The global pharmaceutical companies are still eying China
- 5.2 Challenges to conduct clinical trials in China
- 5.2.1 Lengthy approval process
- 5.2.2 Local language barrier
- 5.2.3 Reporting of adverse events
- 5.2.4 Hardware and qualified logistic support is limited
- 5.2.5 Inexperienced Investigator and CRA
- 5.2.6 The other Local practice
Session 6 How to manage the multinational clinical trial in China
- 6.1 Project team Identification
- 6.2 Timelines
- 6.3 Training
- 6.4 Start-up plan
- 6.4.1 Site selection
- 6.4.2 Central Lab
- 6.4.3 Drug Supply
- 6.4.4 Site Contract
- 6.4.5 EDC
- 6.5 Monitoring plan
- 6.6 Risk assessment
- 6.7 Patient Recruitment
- 6.8 Regulatory Strategy Planning
Session 7 Regulatory requirements of a trial
- 7.1 Clinical trial requirements
- 7.2 Clinical trial
- 7.2.1 Phases of clinical trial
- Phase IV Clinical Trial:
- 7.2.2 Responsibilities of the applicant
- 7.2.3 Responsibilities of principal investigator and participating institutions
- 7.2.4 Suspension or cessation of the clinical trial
- 7.2.5 International multi-centre drug clinical trial
- 7.3 Approval of new drug clinical trial
- 7.3.1 Withdrawal of application
- 7.3.2 Return of application
- 7.4 Clinical trial of imported drugs
- 7.4.1 Basic rules for clinical trial rule for imported drugs
- 7.4.2 Clinical trial approval procedure for imported drugs
- 7.4.3 Clinical trial rules for imported drug
- 7.4.4 Clinical research case number of import chemical drugs
- 7.5 Investigational Product
- 7.5.1 The inspection of pilot drug
- 7.5.2 Management of the pilot drug
- 7. 6 Situations that will result in the non-approval of an imported drugs
Session 8 Feasibility & to select investigator in China
- 8.1 Things to consider to conduct feasibility study in China
- 8.1.1 Deploy a Strategy Combining All Intentions
- 8.1.2 PI's Comprehension of Feasibility Study
- 8.1.3 Differences in Medical Terminology
- 8.1.4 Interpretation of Feasibility Data
- 8.1.5 Influential Factors other than Medical Practice (cultures, ethnics, economic lures, and etc.)
- 8.2 Why to conduct feasibility?
- 8.3 Type of feasibility study
- 8.4 Benefits of feasibility study
Session 9 Ethics Committee Submission
- 9.1 Ethics Committees (EC)
- 9.2 Requirement on the Composition of Independent Ethics Committee
- 9.3 Function of Ethics Committee
- 9.4 Submission list example
- 9.5 timeline
- 9.6 Future trends of China EC
Session 10 Drug Preparation
- 10. 1 Drug importation
- 10.2 Drug testing
- 10.2.1 The evaluation procedure for imported drugs quality standard
- 10.2.2 Rules for quality standard evaluation
- 10.2.3 The coverage of quality standard evaluation
- 10. 3 Drug labeling
- 10.4 Drug Supply
Session 11 Initiation a study
- 11.1 Contract issue
- 11.2 PI grant issue
- 11.3 ICF issue
Session 12 Safety issue
- 12.1 Safety Related Regulation for clinical trial
- 12.1.1 China Drug Administration Law
- 12.1.2 China Drug Administration Law Guideline
- 12.1.3 China Drug Registration Procedure
- 12.1.4 China GCP
- 12.2 Post-marketing Safety Monitoring
- 12.3 SAE reporting figure
Session 13 To select a CRO in China
- 13.1 International CROs in China
- 13.2 CRO market share in China
- 13.3 How to find an appropriate CRO in China
- 13.4 Future trends of China CRO industry
Appendix 1 China Good Clinical Practice (2003 version)
Appendix 2 GCP site list in China
Appendix 3 Drug Registration Regulation
- Chapter 1: General Principles
- Chapter 2: Basic Requirements
- Chapter 3: Clinical Trials of Drugs
- Chapter 4: Application and Approval of New Drugs
- Chapter 5: Application and Approval of Generic Drugs
- Chapter 6: Application and Approval for Imported drugs
- Chapter 7: Application of OTC Drugs
- Chapter 8: Supplemental Application and Approval
- Chapter 9: Re-registration of Drugs
- Chapter 10: Inspection During Drug Registration
- Chapter 11: Drug Registration Standards and Insert Sheets
- Chapter 12: Prescribed Timeline
- Chapter 13: Reconsideration
- Chapter 14: Legal Liability
- Chapter 15: Miscellaneous