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P125: Developing a Bridge for Small Chinese Biotech Companies to Conduct Clinical Trials in the US

Poster Presenter

Marion Stamp-Cole

Director Clinical Services
Pharmaron US Clinical Services
United States

Objectives

To assist Small Chinese Biotech companies in comprehending the pathway to conduct clinical trials in the United States.

Method

A panel of 20 small biotech companies based in China were queried, to determine difficulties initiating clinical trials in the United States. Categories queried for understanding the US conduct of these studies included: regulatory, legal, insurance, site & vendor management, trial design & medical.

Results

Most of these Chinese companies have a good understanding of the ICH/GCP guidelines and the regulatory requirement in China for drug development, however, it is not the same in the United States. There are often challenges with language, cultural differences, legal, regulatory, and contrast in procedures. The results of these discussions determined that most of the small China based biotech companies lacked understanding and expertise in the following: Regulatory: Inadequate understanding of the FDA IND requirements and to deal with the agency. Legal: Lacked the expertise to understand the subtleties of developing contracts with CROs, sites, and other vendors. Insurance: Do not know how much clinical trial insurance is necessary and the specific vendors Site Management: How to foster enrollment, clinical and regulatory protocol adherence. Vendor Management: Contracting, instructing, and payment are frequently misunderstood. Medical Monitor: The specific role of the medical monitor is frequently different than what these companies’ are custom to. Clinical Trial Design: Early phase study design with a dose expansion is important to patient access and the collection of further drug safety data. Patient Engagement: Sponsors frequently have major misunderstanding of the difficulty of enrollment and new diversity regulatory requirements. In addition, sites and patients have many options in the US for clinical trial participation.

Conclusion

Many of these problems will be ongoing and one solution is establishing a clinical trials "Bridge" between China and the United States by having a CRO provide the following: • Project manager or lead clinical research associate who speaks both mandarin and English as well as understanding both the Chinese and American culture. • Provide additional education and guidance that is not usually provided in a clinical trial such as o Regulatory education and support on procedure in the US for IND submissions o Help securing legal support such as pharmaceutical experienced attorney. o Clinical trial experienced insurance agent o Site engagement education for capability and feasibility process o Medical strategy using the medical monitor and key opinion leaders, for clinical trial design. o Patient centric approaches to clinical trials that encourage patient engagement. • This bridge helps establish a pathway for the clinical development of pharmaceutical products from small Chinese biotech companies to conduct clinical trials in the United States.