I guess when nasty bloggers and CNN reporters come down on us for seeking treatment outside the U.S., we can simply say we are outsourcing a clinical trial using our own stem cells. Works for me. I have had enough of these types of people intruding in our lives with their fatuous and ominous remarks.
Edited today:
One of our members took this post to mean that I am in favor of the outsourcing of clinical trials to China. I am most certainly not. What I meant was that the nasty bloggers and the CNN reporters that acted aghast that anyone would leave the U.S. to get treatment, should take a look at this situation. They are continually preaching that unless we have endless clinical trials here in the U.S. then safety will most assuredly be compromised. That's why I started to fume when I read about the outsourcing of clinical trials to China. I thought surely it must be a joke, but it's not. Since our own stem cells are now drugs according to the FDA, I sarcastically was saying that we can travel outside the U.S. for treatment and tell these nosy reporters and nasty bloggers that we are simply outsourcing our own clinical trial for the new drugs that we now know we all have circulating in our bodies. This really takes the cake if you ask me. This is one reason the FDA has declared our own stem cells to be drugs. They know that most small clinics and doctors cannot afford to conduct clinical trials. Even Big Pharma is trying to cut costs by outsourcing. Things are too costly and too time consuming for the most part. Instead of running smoothly, the FDA has become like some kind of slow sludge and we are the ones who suffer. Time for a big change. We simply cannot afford to let the FDA give domain of our cells to the pharmaceutical industry so that they can outsource the clinicals to China.
Clinical Trial Outsourcing: Why China?
Life Science Leader, February 2009
Written by: Mike Anello
Recent trends show that an ever-increasing percentage of clinical trials are being performed offshore. As the pressure increases to reduce the cost of prescription drugs, pharmaceutical manufacturers search for ways to reduce costs in research and production. Outsourcing of clinical trials can provide many benefits to the enterprise interested in reducing preapproval expenditures. However, many factors such as national infrastructure, patient pool, quality of data, and clinical expertise must be weighed before selecting the appropriate venue for each particular trial.Marc Hagan, CEO for Cordium Links, a provider of cardiac safety assessment and diagnostic services for biopharmaceutical companies and clinical research organizations (CROs), views the outsourcing of clinical trial work as a positive, cost effective alternative for companies needing such services. Hagan says, ?There are hot spots of activity for North American pharmaceutical companies to offshore their clinical research. These include places such as Latin America, Eastern Europe, and Russia.? Countries like Argentina, Brazil, and Poland, once leaders in offshore clinical trials, still achieve modest double-digit growth rates. However, India and China stand poised to accept ever-increasing and important roles in the future of offshore clinical trials. Hagan agrees, adding that, ?China?s most recent three-year clinical trials growth rate is projected to be 43%, India?s is 46%, and of the other countries, none are even close to those numbers. In fact, the closest is Russia at 23%.? A High Attractiveness Rating AT Kearney?s Country Attractiveness Index compares countries performing clinical trials and assigns relative ?attractiveness ratings.? The United States earned the
highest overall rating, 6.88, in part due to its high marks in regulatory conditions,relevant expertise, and infrastructure. China had the second highest rating at 6.1. While China?s clinical trials expertise contributed to its rating, so too did high marks in categories such as cost efficiency and patient pool.Regarding the latter category, in 2007 the European Union and the United States experienced patient shortages relative to clinical activity volume, while China, India,and Eastern Europe all maintained an abundance of patients relative to their clinical activity. For example, China has significantly more treatment-na?ve patients available than the United States in many categories, including heart disease, stroke (10 times the patients), and diabetes. It is interesting to note that 59% of adult Chinese males are smokers, while only 28% of American males smoke. Hagan adds, ?For our company, given that we focus on cardiac safety, the numbers in China20are rather staggering. It?s estimated that more than 100 million people in China suffer from cardiovascular disease. When you?re looking at other indications like diabetes and central nervous system types of issues, you?re going to find a wealth of subjects that are research-na?ve, which will lead to less expensive and easier recruiting practices.?
China?s growth in spending on over-the-counter (OTC) drugs has been nothing short of impressive. Over the past 10 years, China has shown faster growth in the amount of money spent on OTC and ethical drugs ? excluding Chinese traditional medicine? than any other country in the world. China ranked eleventh in overall spending in
1996, spending $4.3 billion (U.S.). In 2010, China is expected to rank fifth among all nations, spending $24 billion. During the same period, the United States is expected to increase OTC drug expenditures by 512%. Alongside China?s expected growth of over 550%, no other nations compare. China?s low cost for clinical trials also increases the country?s attractiveness. A study of overall indexed clinical trial costs performed in 2006 indicated that the United
Kingdom, Germany, and the United States were the most expensive countries for clinical trials, while Russia, China, and India averaged 50% less. Faster Setup, Quality Data A significant challenge in performing clinical trials is the duration of the study setup. Protocol approval to first patient first visit (FPFV) varies widely=2 0by nation and region.
The United Kingdom and Scandinavian countries are historically the most efficient, averaging around three months in duration, while India averages over twelve months to FPFV. China averages a very efficient 5.5 months to FPFV, and the United States averages 7 months, both below average.
A recent study conducted by Bayer Schering Pharma revealed that China outpaced the rest of the world in respect to many key performance indicators, as well. For example, China provides double the worldwide average of available patients per site. In addition, venograms (a radiograph of a vein after injection of a radiopaque substance) are available at 95% of Chinese facilities, as opposed to 92% globally, and China ranks fourth in the world for the number of clinical research associates available.
In the same study, 100% of clinical trial data was released by its due date, compared to the global average of 83%. The average number of days to answer queries from the trial sponsor was slightly less than the global average, and the total number of queries was 78% of the global average. Hagan and his firm have seen firsthand the advantages of providing services abroad, and more specifically in China. ?We have established a joint venture with a Chinese firm called Lawke Links, through which we have established the very first ECG core lab in Beijing. The market conditions are ripe, and they?re headed in the right direction. The Chinese government has provided nothing but positive indications that they want to encourage this particular industry?s growth within their country.? Hagan explains that labor ? in particular, cardiologists ? is the biggest expense at Cordium Links? core lab in the United States. ?We must have cardiologists on staff to evaluate the ECGs. However, labor in China is inexpensive, as are cardiologists, when compared to U.S. costs. We can perform whatever percentage of work our clients want in China. Then, for quality control purposes, the remaining percentage
can be conducted here in the States.?
Bigger Growth Than The Rest Of The World
Outsourcing of clinical trials is increasing rapidly. According to a Tufts University report, it is estimated that within three years, up to 65% of FDA-regulated clinical trials for major pharmaceutical companies will be conducted abroad. In 2004, the world market for clinical trial outsourcing was $9.7 billion (U.S.) compared to $13.9 billion in 2007. Asian countries are expected to show a compounded annual growth rate of 14% from 2004 to 2010, while the rest of the world is expected to achieve a growth rate of around 9% for the same period. It is clear that many options exist globally to satisfy the growing demand for clinical trials. While the United States and Western Europe offer outstanding benefits, the costs associated can become prohibitive. Eastern European nations, Latin America, and India offer attractive, cost-effective opportunities that may not be as attractive when other factors such as expertise and regulatory conditions are weighed. And as for China, while there are still challenges ahead, the positive attributes of quality, cost-effectiveness, and efficiency are helping it emerge as one of the most attractive choices for clinical trials outsourcing.
Edited today:
One of our members took this post to mean that I am in favor of the outsourcing of clinical trials to China. I am most certainly not. What I meant was that the nasty bloggers and the CNN reporters that acted aghast that anyone would leave the U.S. to get treatment, should take a look at this situation. They are continually preaching that unless we have endless clinical trials here in the U.S. then safety will most assuredly be compromised. That's why I started to fume when I read about the outsourcing of clinical trials to China. I thought surely it must be a joke, but it's not. Since our own stem cells are now drugs according to the FDA, I sarcastically was saying that we can travel outside the U.S. for treatment and tell these nosy reporters and nasty bloggers that we are simply outsourcing our own clinical trial for the new drugs that we now know we all have circulating in our bodies. This really takes the cake if you ask me. This is one reason the FDA has declared our own stem cells to be drugs. They know that most small clinics and doctors cannot afford to conduct clinical trials. Even Big Pharma is trying to cut costs by outsourcing. Things are too costly and too time consuming for the most part. Instead of running smoothly, the FDA has become like some kind of slow sludge and we are the ones who suffer. Time for a big change. We simply cannot afford to let the FDA give domain of our cells to the pharmaceutical industry so that they can outsource the clinicals to China.
Clinical Trial Outsourcing: Why China?
Life Science Leader, February 2009
Written by: Mike Anello
Recent trends show that an ever-increasing percentage of clinical trials are being performed offshore. As the pressure increases to reduce the cost of prescription drugs, pharmaceutical manufacturers search for ways to reduce costs in research and production. Outsourcing of clinical trials can provide many benefits to the enterprise interested in reducing preapproval expenditures. However, many factors such as national infrastructure, patient pool, quality of data, and clinical expertise must be weighed before selecting the appropriate venue for each particular trial.Marc Hagan, CEO for Cordium Links, a provider of cardiac safety assessment and diagnostic services for biopharmaceutical companies and clinical research organizations (CROs), views the outsourcing of clinical trial work as a positive, cost effective alternative for companies needing such services. Hagan says, ?There are hot spots of activity for North American pharmaceutical companies to offshore their clinical research. These include places such as Latin America, Eastern Europe, and Russia.? Countries like Argentina, Brazil, and Poland, once leaders in offshore clinical trials, still achieve modest double-digit growth rates. However, India and China stand poised to accept ever-increasing and important roles in the future of offshore clinical trials. Hagan agrees, adding that, ?China?s most recent three-year clinical trials growth rate is projected to be 43%, India?s is 46%, and of the other countries, none are even close to those numbers. In fact, the closest is Russia at 23%.? A High Attractiveness Rating AT Kearney?s Country Attractiveness Index compares countries performing clinical trials and assigns relative ?attractiveness ratings.? The United States earned the
highest overall rating, 6.88, in part due to its high marks in regulatory conditions,relevant expertise, and infrastructure. China had the second highest rating at 6.1. While China?s clinical trials expertise contributed to its rating, so too did high marks in categories such as cost efficiency and patient pool.Regarding the latter category, in 2007 the European Union and the United States experienced patient shortages relative to clinical activity volume, while China, India,and Eastern Europe all maintained an abundance of patients relative to their clinical activity. For example, China has significantly more treatment-na?ve patients available than the United States in many categories, including heart disease, stroke (10 times the patients), and diabetes. It is interesting to note that 59% of adult Chinese males are smokers, while only 28% of American males smoke. Hagan adds, ?For our company, given that we focus on cardiac safety, the numbers in China20are rather staggering. It?s estimated that more than 100 million people in China suffer from cardiovascular disease. When you?re looking at other indications like diabetes and central nervous system types of issues, you?re going to find a wealth of subjects that are research-na?ve, which will lead to less expensive and easier recruiting practices.?
China?s growth in spending on over-the-counter (OTC) drugs has been nothing short of impressive. Over the past 10 years, China has shown faster growth in the amount of money spent on OTC and ethical drugs ? excluding Chinese traditional medicine? than any other country in the world. China ranked eleventh in overall spending in
1996, spending $4.3 billion (U.S.). In 2010, China is expected to rank fifth among all nations, spending $24 billion. During the same period, the United States is expected to increase OTC drug expenditures by 512%. Alongside China?s expected growth of over 550%, no other nations compare. China?s low cost for clinical trials also increases the country?s attractiveness. A study of overall indexed clinical trial costs performed in 2006 indicated that the United
Kingdom, Germany, and the United States were the most expensive countries for clinical trials, while Russia, China, and India averaged 50% less. Faster Setup, Quality Data A significant challenge in performing clinical trials is the duration of the study setup. Protocol approval to first patient first visit (FPFV) varies widely=2 0by nation and region.
The United Kingdom and Scandinavian countries are historically the most efficient, averaging around three months in duration, while India averages over twelve months to FPFV. China averages a very efficient 5.5 months to FPFV, and the United States averages 7 months, both below average.
A recent study conducted by Bayer Schering Pharma revealed that China outpaced the rest of the world in respect to many key performance indicators, as well. For example, China provides double the worldwide average of available patients per site. In addition, venograms (a radiograph of a vein after injection of a radiopaque substance) are available at 95% of Chinese facilities, as opposed to 92% globally, and China ranks fourth in the world for the number of clinical research associates available.
In the same study, 100% of clinical trial data was released by its due date, compared to the global average of 83%. The average number of days to answer queries from the trial sponsor was slightly less than the global average, and the total number of queries was 78% of the global average. Hagan and his firm have seen firsthand the advantages of providing services abroad, and more specifically in China. ?We have established a joint venture with a Chinese firm called Lawke Links, through which we have established the very first ECG core lab in Beijing. The market conditions are ripe, and they?re headed in the right direction. The Chinese government has provided nothing but positive indications that they want to encourage this particular industry?s growth within their country.? Hagan explains that labor ? in particular, cardiologists ? is the biggest expense at Cordium Links? core lab in the United States. ?We must have cardiologists on staff to evaluate the ECGs. However, labor in China is inexpensive, as are cardiologists, when compared to U.S. costs. We can perform whatever percentage of work our clients want in China. Then, for quality control purposes, the remaining percentage
can be conducted here in the States.?
Bigger Growth Than The Rest Of The World
Outsourcing of clinical trials is increasing rapidly. According to a Tufts University report, it is estimated that within three years, up to 65% of FDA-regulated clinical trials for major pharmaceutical companies will be conducted abroad. In 2004, the world market for clinical trial outsourcing was $9.7 billion (U.S.) compared to $13.9 billion in 2007. Asian countries are expected to show a compounded annual growth rate of 14% from 2004 to 2010, while the rest of the world is expected to achieve a growth rate of around 9% for the same period. It is clear that many options exist globally to satisfy the growing demand for clinical trials. While the United States and Western Europe offer outstanding benefits, the costs associated can become prohibitive. Eastern European nations, Latin America, and India offer attractive, cost-effective opportunities that may not be as attractive when other factors such as expertise and regulatory conditions are weighed. And as for China, while there are still challenges ahead, the positive attributes of quality, cost-effectiveness, and efficiency are helping it emerge as one of the most attractive choices for clinical trials outsourcing.
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