Top 10 Countries For Diabetes Clinical Research
Published: Nov 21, 2014
November 19, 2014
By Renee Morad, BioSpace.com Breaking News Staff
When it comes to diabetes clinical research, there are seven countries that are more advanced than the United States, according to KMR Group, a firm that analyzes R&D performance data for the biopharmaceutical industry.
Mexico takes the helm, with China and India trailing behind.
“This is not surprising since these countries are experiencing some of the fastest growth rates of diabetes and already have an established infrastructure for diabetes clinical research, as well as high patient access,” according to the report.
The United States takes the No. 8 spot, ranking just above Russia.
“Eight of the top 10 countries are from emerging markets: Mexico, China, India, Romania, Poland, Hungary, Russia, and Argentina,” the report states. “Emerging markets offer an appealing option for clinical research, with lower cost and greater access to patients serving as key factors.”
The reports are based on KMR Group clinical data provided directly from biopharmaceutical clients. This includes 567 diabetes trials conducted by 18 large to mid-size biopharmaceutical companies. Over 16,400 sites enrolled 127,959 subjects for these trials. The rankings are based on activity from 2009 to 2014, according to KMR Group. The rankings for each country are based on key factors including performance, infrastructure, patient access, and cost. They help companies more easily and reliably identify places of key interest for the purpose of conducting clinical research.
KMR Group’s study also highlights some significant findings regarding diabetes clinical research. For example, the time needed to begin randomizing subjects in a given country ranges from 3 to 17.9 months. The number of subjects randomized by a given site on a country basis is 2.4 to 17.5 subjects. The country medians for subjects randomized per month at a given site range from 1 to 4.4 subjects. Furthermore, North America and West Europe together account for nearly 50 percent of total trials.
Read on for more specifics on how each country fares.
10. Canada and Argentina
Eyes have been on Canada this November for diabetes research developments. For example, ProMetic Life Sciences has reported that its small molecule lead compound PBI-4050 has been approved to commence clinical trials in patients suffering from Diabetic Kidney Disease following the CTA clearance by Health Canada.
“The acceptance of our Clinical Trial Application by Health Canada represents an important milestone in the PBI-4050 clinical development program,” said Pierre Laurin, president and chief executive officer of ProMetic.
Argentina, which tied with Canada for the 10th best country for diabetes clinical research, ranked much lower for time to start clinical trials, taking the 54th spot. This country ranked 3rd, following China, for the number of subjects per site, reporting a median of at least eight subjects per site. It also rounded out the top five for number of subjects randomized per month at a given site.
This past October, a study conducted at the Hospital Universitario Sanatorio Guemes in Buenos Aires, Argentina and published in the Endocrine Society’s Journal of Endocrinology & Metabolism (JCEM), suggested that men who have low testosterone and type 2 diabetes face a greater risk of developing atherosclerosis, a condition where plaque builds up in the arteries, than men with diabetes and normal testosterone levels.
Russia ranked 37th for time needed to begin randomizing subjects. It ranked 11th regarding number of subjects randomized per month at a given site and 8th for unique sites.
Russia has been known for its research regarding the topical issues of modern strategies in antihypertensive therapy in patients with noninsulin-dependent diabetes mellitus (NIDDM) and hypertension (HTN). Participants are currently being recruited in two studies to assess the clinical efficiency of oral drug Subetta in the combined treatment of type 2 diabetes mellitus and the combined treatment of type 1 diabetes mellitus.
8. United States
The United States ranked 1st when it came to the time needed to begin randomizing subjects, thanks to an efficient regulatory process that is easy to navigate. The U.S. also took the No. 1 spot for diabetes subjects and unique sites.
The Diabetes Prevention Program (DPP), a large clinical trial sponsored by the National Institutes of Health, is one example of the U.S. making progress in diabetes research. The program is looking at several strategies to prevent conversion to type 2 diabetes by adults with prediabetes.
Hungary ranked 29th for time to start clinical trials. It ranked 16th for number of subjects randomized per month at a given site.
In Hungary, a clinical trial was recently carried out in Hungarian type 2 diabetic patients whose treatment was insufficient with oral antidiabetic agents.
Germany ranked 11th, following closely behind the U.K., for time needed to start clinical trials. This country stole the No. 4 spot for diabetes subjects and the No. 3 spot for unique sites.
A randomized prospective trial will test a new developed treatment and education program for type 1 diabetic patients compared to an established treatment and education program in Germany.
Poland ranked 39th for time needed to start clinical trials. It ranked 8th for diabetes subjects and 6th for unique sites.
A study at the Medical University of Warsaw tested whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart in children with type 1 diabetes treated with the insulin pump.
Romania ranked 31st—along with Mexico—for time needed to start randomizing subjects. It came in 13th for number of subjects randomized per month at a given site. Along with Mexico, this country placed 5th for diabetes subjects.
Among the many trials completed in Romania is a study, sponsored by Novo Nordisk A/S, evaluating the blood glucose control using NovoRapid (insulin aspart) and Levemir (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal conditions in Romania.
India ranked 52nd, along with Colombia, for time needed to start randomizing subjects. It ranked 7th for diabetes subjects and 9th for unique sites.
Since people from the Indian subcontinent are more likely to get diabetes, even at younger ages, this country is particularly significant for clinical trials. For example, the Diabetes Community Lifestyle Improvement Program has studied participants in Chennai, India for type 2 diabetes prevention for high-risk individuals.
China, along with Canada, ranked 8th out all countries for the time needed to begin randomizing subjects. This country ranked 2nd, behind Venezuela, for the number of subjects per site, reporting a median higher than eight subjects per site. It ranked 3rd for diabetes subjects.
As of March 2014, a Phase II clinical trial conducted on the Stem Cell Educator, a device being tested as a potential cure for type 1 diabetes, was recruiting people spread across several locations in China and Spain. Dr. Yong Zhao developed the Stem Cell Educator and created his company, Tianhe Stem Cell Biotechnologies, Inc., to commercialize the device.
Mexico ranked 31st, in a tie with Romania, for time needed to begin randomizing subjects. This country ranked 5th, in a tie with Vietnam, for number of subjects per site. It rounded out the top five, in a tie with Romania, for diabetes subjects and came in 7th for unique sites.
Among its varied research, a study, sponsored by the Mexican National Institute of Public Health, focused on the effect of a treatment of lifestyle changes on the prevalence of metabolic syndrome and body weight in women in Mexico.