Right now it seems as though regulators are struggling to keep pace with growth, especially for clinical trials in China and India. The extensive bribery allegations against GSK, which they said they’re investigating, and the CFDA’s (Chinese Food and Drug Administration’s) vows yesterday for a major crackdown on corruption between now and December may reveal even more allegations and hesitancy among the top pharma companies.
John Lewis, VP of public affairs for ACRO (Association of Contract Research Organizations) told Outsourcing-Pharma.com that China is one of the slowest countries in terms of approving trials as it “can take up to 18 months.”
“As a relatively new market, quality control remains very important, as does proper training of investigators,” he said regarding China, noting that “there are some indications” trial approval times are “beginning to shrink...China is in the process of evaluating its entire food and drug regulations and structure so we are optimistic.”
Similarly, India’s CDSCO (Central Drugs Standards Control Organization) has come under pressure from the country’s Supreme Court and Parliament over the last year to do more to protect patients in clinical trials. Since Parliament released a report last summer outlining a number of issues, CDSCO created expert committees to review drug trials, altered its compensation rules to be more patient-friendly, and may even begin registering CROs. But questions still surround the timelines for when the changes will take effect.
“India is shrouded in regulatory uncertainty, especially around the issue of compensation for serious adverse events or injuries in clinical trials,” Lewis said. “Until the regulatory system is stabilized, and there is clear direction from the government that clinical research is again welcome in India, activity is likely to be very limited. Though we are seeing some positive signs.”
On July 26, India’s Supreme Court will hold a hearing to discuss the changes and what else needs to be done. Until then, clinical trials seem to be pulling out of India. The US NIH (National Institutes of Health) made headlines recently for pulling an unknown number of trials from the country, although according to Clinicaltrials.gov, there are more than 30 NIH-funded clinical trials in India still pending.
Another scandal to rock the Asian trials sector is allegation by Japan's Health Minister Norihisa Tamura last Friday that data from a study of Novartis' Diovan was fabricated. But this case while undoubtedly damaging for the firms involved, should not be seen as representative of wider shortcomings in Japan's trials system according to Lewis.
“Japan is actually a very established, stable and growing market for clinical research as it has become much more open to global trials in recent years,” he noted. “Japan has a very highly-trained investigator community and the quality of its research is excellent, at least equal to the US and Western Europe.”
Whether the various Governments can improve the regulatory environment fast enough to offset damage caused by the current scandals and maintain the trials boom remains to be seen, but, judging by ACRO's comments and the growing number of CROs exploring new Asian markets like Indonesia, the region's clinical research sector is not yet bust.