China's Service Sector Will Reign, Part IX -- World's Best For Clinical Trials
A recent AT Kearney report names China as the "most attractive" offshore clinical trial location, according to this article at Outsourcing-Pharma.com. I was unable to find the original report.
According to the article, China is the "most attractive low-cost global" location in which to run clinical trials, followed in order by India, Russia, Brazil and The Czech Republic. The report based its findings on each country's "decision-making process ' patient availability, cost-efficiency, expertise, regulatory conditions and infrastructure."
China was chosen "because it has the largest urban patient population in the world ' providing a vast patient pool ' in addition to a huge network of hospitals with over 2.5m doctors, nurses and technicians, all on significantly lower salaries than their western counterparts." Conducting trials in China costs about half that of the United States. China is "actively trying to encourage new clinical activity from foreign firms, introducing a series of new regulations and improving existing ones in order to simplify and streamline the clinical trials process."
The article notes "clinical trials account for two thirds of the development cost for new drugs and offshoring to locations outside the US is becoming a common way to help pharma firms keep costs down by providing access to a new range of patients." Cheaper labor and site fees are also factors. In 2005, nearly half of the 1200 clinical trials conducted by the twelve largest US pharmaceutical companies included an offshore location.
In a previous post, I talked about the reasons given by my firm's clinical testing clients for having chosen China:
China has become a worldwide center for medical testing. My firm's medical testing clients tell us they are in China because China has a large number of people capable of administering the tests, recording the results, and collating and analyzing the data, all at low cost. They also tell us that China makes for good testing because their test subjects are, for the most part, literate, responsible, and stable. Our clients tell us they are not in China to circumvent any medical testing standards. I believe them because none of them have ever made any effort to avoid any legal requirements.
Add medical testing on the expanding list of hot areas for foreign service businesses in China.
Comments (2)
Read through and enter the discussion by using the form at the enddavesgonechina - January 5, 2007 7:40 AM
Clinical trials anywhere in the developing world, as you are no doubt aware, can be quite controversial. There's been some coverage (in the journal Nature, and some links at SciDev.net below) about the lack of a good medical ethics structure in China for trials, and the possibility of lack of consent by informed patients. I realize your clients are not looking to subvert international or Chinese standards, but the system is fraught with flaws.
I knew a researcher in China who studied blood supply management that included Hepatitis testing. He discovered a nightmare - mislabeled or unlabeled samples in unorganized collections, no standard practice on informing patients (you'll be told of your test results by phone, by mail, come to the office in two weeks, results will be in a brown paper bag behind a steampipe at the KTV at 3 am Friday morning - some patients were never told they were even being tested, let alone told if they were positive). If problems like these exist, clinical trials will no doubt sometimes be carried out with similar deficiencies.
I also taught at a medical university, and I routinely heard of students and professors falsifying data to achieve desired results. There was no disincentive or watchdog mechanism to prevent this.
If one day it is revealed that your clients had contracted out trials to a Chinese hospital that failed to inform patients properly or misrepresented data, what actions would you advise them to take? What precautions do they take now?
nanheyangrouchuan - January 5, 2007 5:46 PM
The "human rights" dragon raises its head again. China has a vast pool of patients and even more importantly, desperately poor who will put themselves through anything just to make a yuan. Just like "compliant" chinese factories geared for outsourcing, any inspectors from western pharm companies will at best get a dog a pony show while the meat grinder in the back room works its magic on its victims. And western pharm companies can claim complete ignorance!
Yeah, QC in china is a big problem, look at the cars. And you will trust a drug tested in China coursing through your veins? It's a perfect storm for more thalydamide babies: western companies wantin inexpensive and sort of reliable testing and the chinese testing companies want to maximize profits and increase their western pharm customers with "perfect results".
I'll be shifting my healthcare plan to holistic healers, native american medicine men and power crystals. Much safer.