China has the most to offer as a destination for pharmaceutical companies looking to shift their clinical trials from mainstream markets such as the US, Canada and Western Europe, a new report has found.
The report on outsourcing clinical trials by US-based Arrowhead Publishers includes a location attractiveness index that ranks 31 “ascending” markets for clinical studies around the world according to seven measures of attractiveness. China came out top with an average index of 6.48, followed by India with an average of 5.66.
There was then a sizeable gap between India and the third most attractive international location for clinical trials – Brazil with an average index of 3.58. Not far behind were the number four and five destinations, Australia and Russia respectively with average scores of 3.43 and 3.29. The least appealing location out of the 31 countries assessed was found to be Ukraine, with an average index of 2.04.
The overall rankings were calculated from the following seven indices, each of which was given equal weight in the final score: study costs, based on six different indicators (e.g., labour costs, physician salaries, infrastructure costs); population/patients (seven indicators); disease incidence (16); clinical research (five); research personnel (five); study sites (six); and business environment (five).
Population strongest pull
Not surprisingly, China’s strongest pull was its patients/population, which in the Arrowhead Publishers' report incorporated indicators for urban populations, treatment naivety, treatment acceptance and patient recruitment/enrolment rates. Here China achieved an index of 8.98 compared with 8.39 for its study sites and 7.04 for study costs. The country was by some distance the most attractive of the 31 offshoring locations in terms of patients/population – India scored 7.38 and then the nearest competitor was Brazil with an index of 4.22.
China was also far and away the premier location for study sites (India = 5.39), although on study costs it was roundly beaten by a number of Central and Eastern European markets: namely, Slovenia with an index of 9.56, Estonia with 9.37, Belarus with 9.20 Russia with 8.46, Lithuania with 7.33 and Slovakia with 7.07. Also ranked higher than China for study costs were Argentina (7.72) and the Philippines (7.37). India had a study cost index of 6.95.
Coming under strain
As intense global competition and aggressive financial targets put “tremendous pressure” on pharmaceutical companies to develop and launch novel therapies as quickly as possible, the finite numbers of trial subjects and investigators in mainstream markets are coming under strain, the report notes.
Trial workloads have increased exponentially in the face of globalisation, more stringent regulations and heavier documentation. At the same time, the pool of available investigators in markets such as the US is shrinking, the report observes. Many of these investigators are not interested in conducting further studies after the first or second round, while a lack of financial incentives, the growing complexity of trial protocols, the increasing burden of compliance and slow payment processes have added to the inertia.
By contrast, the Arrowhead analysts point out, the ascending markets for clinical trials offer a number of winning features, including:
- A large pool of enthusiastic investigators;
- Training comparable to western markets – “there has been a tremendous surge in efforts to improve cGMP [current Good Manufacturing Practice] education and compliance training;”
- Significantly lower compensation costs; and
- Greater acceptance of clinical trials both socially and culturally, leading to better patient compliance.
As China can testify, there is also the powerful draw of access to large patient populations. This promises “long-term growth as there is no immediate threat of diminishing numbers of treatment-naïve patients,” the researchers comment.