Study throws doubt over China's clinical trial quality

As China's contract clinical trials industry heats up, a new study casts doubt over the quality of the research being conducted in the country.

Researchers from the Department of Public Health and Epidemiology and the Department of Primary Care and General Practice at the University of Birmingham, UK, as well as the Institute of Respiratory Diseases, Guangzhou Medical College, China, concluded that "reporting of randomised controlled trials (RCTs) in China requires substantial improvement to meet the targets of the CONSORT statement".

Consolidated Standards of Reporting Trials (CONSORT) is a set of international guidelines pertaining to the conduct and the reporting of RCTs. It includes recommended items designed to report the methodology and conduct of a study that are common to many standard quality assessment checklists.

"The conduct of Chinese RCTs cannot be directly inferred from the standard of reporting; however without good reporting the methods of the trials cannot be clearly ascertained," the researchers added.

These conclusions were drawn after a systematic review of RCTs conducted in China and published in 2004, to ascertain their characteristics, assess the quality of their reporting, and the quality of their conduct.

It was found that out of 307 RCTs that were analysed, 199 (65 per cent) failed to report methods of randomisation and 254 (82 per cent) did not mention blinding of either participants or investigators.

"Reporting of baseline characteristics, primary outcome and length of follow-up was inadequate in a substantial proportion of studies," researchers wrote, citing the fact that less than 11 per cent of RCTs mentioned ethical approval and only 18 per cent "adequately discussed" informed consent.

However, they did point out that on a positive note, dropout rates were very "favourable" with nearly 44 per cent of trials reporting a zero dropout rate.

When citing the motivation behind conducting such a study, the researchers explained that "despite the rapid increase in research in China, little is known about the quality of clinical trials conducted there".

"China is a developing country with the biggest population in the world. Research in China has been rapidly gaining momentum, but as yet there is no systematic evaluation of the current standard of trials conducted there... Evaluations of the quality of Chinese RCTs have been restricted to selected journals or fields, and often a limited list of quality indicators", they said.

Indeed, according to data emerging from a study initiated by researchers from the Massachusetts Institute of Technology (MIT), titled: Trends in the globalization of clinical trials, in terms of the number of clinical studies being outsourced to emerging regions, India and China have "grown rapidly from an almost negligible base in just several years" and their high average relative annual growth rates, coupled with their very low density of trials and current levels of investment in clinical research infrastructure, suggest that they have potential to grow into "major players" in the future.

According to a report released by India´s Planning Commission, 139 trials were recently outsourced to India by global pharma companies, along with 98 to China.

In terms of Asia's rapidly growing clinical trials industry, India and China are the two powerhouses that are competing heavily with each other for the attention of global pharmaceutical companies.

At present, India appears to be winning the race in Asia and this recent study, titled: An assessment of the quality of randomised controlled trials conducted in China, and published on BioMed Central, may only serve to advance India further in the reputation stakes.