China

Clinical Trial Strategies for Small Pharma

Nicholas P. Zemo

Nicholas P. Zemo

Vice President, Business Development & Sales, Accelovance, China

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Utilising a company that is based in China and understands both ICH GCP and China SFDA GCP requirements is very important for ensuring clinical trial integrity and success.

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Offshoring clinical research is becoming more prevalent as the biopharmaceutical industry seeks to address the escalating time and cost for drug development. Implementing such a strategy in China presents three key opportunities: availability of patients, favourable cost structure, and the world’s fastest growing pharmaceutical market. These opportunities are so compelling that large pharmaceutical companies feel they cannot afford NOT to be there and many have been investing in infrastructure in China for years. However, smaller companies typically do not have the internal resources (capital, personnel, capacity, or time) necessary to take advantage of these opportunities. Armed with knowledge of the processes and challenges associated with clinical trials, there are strategies smaller companies can undertake to realize the benefits of conducting trials in China.

The time for the regulatory review and approval of clinical trial application process poses a major consideration when deciding whether or not to conduct a trial in China. It typically takes approximately ten months for the China State Food and Drug Administration (SFDA) to approve clinical trial applications. Depending on the study’s enrolment period and/or the ability to submit an application early, this has considerable impact on what types of trials benefit the most by being conducted in China. It should be noted that the ability to recruit patients in China faster than any other region in the world might offset the initial regulatory delay. The lengthy approval process is a significant concern and the China SFDA is working closely with global industry leaders and regulatory bodies to improve its processes. There is optimism that in the near future the approval process will become more favourable; however, for the present time, it poses a considerable obstacle and must be evaluated.

Another regulatory consideration is that the China SFDA typically requires some existing clinical data and/or long-term toxicology data before approving a clinical trial application. This precludes doing first-in-man Phase I studies at the IND stage.

While planning regulatory strategy, companies should consider designing the China component of the trial to position the drug for eventual China market approval. China’s pharmaceutical market is currently ranked seventh in the world and is projected to be fifth by the year 2010 and second by 2020 with revenues experiencing continued double-digit growth. This is an opportunity that could bring tremendous value in terms of potential revenue. New revenue streams, particularly for small companies, may enable the companies to reinvest and expand their existing portfolio. Designing a trial with this intent not only enhances the value of the trial itself, it also eliminates associated ethical issues and scepticism about conducting the trial without the intent of making the drug available to the Chinese population.

The strategy to conduct later stage clinical trials for difficult to enrol indications with long enrolment periods could provide significant value to the sponsor. For many of these indications and therapeutic areas, the ability to recruit patients in China and complete enrolment is much faster than in the west. Several small, US based biotech and pharma companies have pursued China to access and recruit patients faster and more cost effectively than western locations. The results have been impressive; randomising twice as many patients in one-half the time of the originally scheduled enrolment period (regulatory approval time not withstanding).

Maintaining ICH GCP quality and ethical compliance are the key industry concerns for conducting global trials in China. The confidence level around quality is rising quickly as indicated by the increasing number of FDA IND products being tested in China. To ensure quality compliance, clinical trials are currently only conducted in hospitals that are China SFDA GCP certified. Despite this government involvement and approval, there is still a concern with western companies that a gap exists between SFDA GCP and ICH GCP standards. Companies need to carefully select their development partners and address quality concerns to ensure that the gap is filled for acceptance by the FDA and studies are conducted under ICH GCP guidelines. China poses cultural, language and logistical challenges that must be addressed for any venture to succeed. Understanding the Chinese culture is critical in all aspects from establishing strong business relationships to ensure the patients, investigators, and research staff understand, adhere to, and execute the trials according to ICH GCP without bias. A comprehensive understanding of the culture from a social, economic and government perspective also helps to maximise the roles of hospitals, doctors, monitors, the government and local partners. The Chinese language presents a communication barrier, making it essential to have proper translation and interpretation to define goals and clarify expectations of all parties. For the small pharma and biotech company conducting clinical trials in China without operations in the country, logistics are of great concern. Logistics can be challenging with long distances between labs, dealing with different time zones and working with unfamiliar customs requirements. General travel costs and their frequency must also be factored into the business decision and emphasise the need for a qualified partner located in China to maintain control over timelines and budgets.

For smaller companies without resources in China, it is important to work with an organisation that can address the challenges mentioned and help capitalise on the opportunity and minimize risk. Utilising a company that is based in China and understands both ICH GCP and China SFDA GCP requirements is very important for ensuring clinical trial integrity and success. Additionally, this partner should help the sponsor by bringing a thorough understanding of both Chinese and Western cultures and languages to ensure that trials are processed and executed with efficiency. Partnering with Chinese biopharmaceutical companies is a strategy for funding both clinical trials and commercialisation activities. Such a business arrangement allows companies to overcome capital and resource limitations and is embraced by the Chinese as a way to capitalise on the opportunity to add late stage candidates or approved drugs to their portfolios.

China offers tremendous opportunities relative to the availability of patients, lowcost clinical trials, and potential revenue. Smaller companies should realise that they can benefit as well, despite limited resources. To implement the appropriate strategy, the real opportunity must be identified and executed in a high quality manner. Resources and capital can be made available to fund these strategies through partnering with Chinese biopharmaceutical companies. In the end, this opportunity is great for the small biotech and pharma companies and China, which benefits from the availability of these drugs into their healthcare system.

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