Updated on 5 September 2013
Clinical trial duration, a challenge
In the last few years, the duration of performing clinical trials has also emerged as a major challenge for China's clinical research industry. As per Chinese government reports, the country averages an efficient 5.5 months to first patient first visit (FPFV). As compared to this, the United Kingdom and Scandinavian countries have held the record of being the most efficient, averaging around three months in duration, India averages over 12 months and the US averages seven months. However, factors such as disease burden act as motivation for the functioning of clinical research firms. The disease burden in China is growing at an alarming pace. It is estimated that two years back there were 92 million people with diabetes and 148 million with pre-diabetes in China.
Between 2011-16, the Chinese government planned to invest $1.5 billion in new drug development. A study conducted by Bayer Schering Pharma revealed that China outpaced the rest of the world in respect to many performance indicators. The study showed that China can provide double the worldwide average of available patients per site.
Further, venograms, which is a radiograph of a vein after injection of a radiopaque substance, are available at 95 percent of Chinese facilities, as opposed to 92 percent globally. In terms of the availability of clinical research associates, China ranks fourth in the world. Today, pharmaceutical majors from across the world are not just outsourcing their work to Chinese CRO's but are also entering into long-term partnerships with them. These partnerships mean sharing profits and co-developing drugs specifically for the Chinese market. A whole host of US- ased CROs are further setting a trend by making strategic partnerships with Chinese companies to study the Chinese regulatory system more closely.
In recent times, China's Center for Drug Evaluation released a long-term proposal document that charts out the country's action plan to improve the regulation and management of clinical trial data. The proposal to standardize pharmaceutical clinical trial data management' laid down some ambitious medium to long term goals for improving the management of clinical trial data in the country. It also acknowledges the lack of unified rules and variable standards. The three core points mentioned in the proposal are preparation of unified rules on data management, setting up an accessible registry of trials and building a database.
Experts claim that addressing these issues, which have in the last decade of boom proved to be China's clinical trial bottleneck leading to a stunted drug efficacy and international competitiveness, would help the country achieve dominance in the sector globally.