A country the size of New Jersey claims 3% of worldwide trials.
June 8, 2011 | Israel, a small country of seven million, often described as the size of New Jersey, has emerged as a clinical trials powerhouse. With its highly skilled workforce, widespread adherence to good clinical practice (GCP), and strong patient enrollment rates with relatively few lost to follow-up, global life sciences companies view Israel as a key clinical trials destination. According to data from clinicaltrials.gov, nearly 2,900 registered studies are currently being conducted in Israel, representing almost 3% of worldwide studies registered on the Web site.
“More clinical trials are conducted in Israel than in Africa, Russia, India or Japan,” says Ahuva Koren, president and CEO of GCP Clinical Studies, a provider of clinical research services and educational programs in Israel.
Studies in Israel are mostly conducted in the pharmaceuticals, biotech, and “other” category, i.e. medicinal herbs and investigator-initiated studies, but the country has a particular focus on medical device trials. “An important reason for focusing on medical device development is that time to market is very much shorter than drug development and hence development costs are much less,” Koren explains.
Several factors driving the medical device market in Israel are spelled out in a January 2011 report by PwC entitled Race for Global Leadership: Medical Technology Innovation Scorecard. Medical technology executives surveyed for the report ranked Israel first in the world in ease of regulatory approval. The country ranked third in the world in medical technology innovation behind first place United States and a cluster of other highly industrialized and more populous nations, such as the UK, Germany, and Japan. The rankings are based on five pillars of innovation: powerful financial incentives, innovation resources, a supportive regulatory system, demanding and price-insensitive patients, and a supportive investment community.
According to the report, Israel is particularly strong in attracting venture capital investment in medical technology and leads the world in ease of obtaining reimbursement for new medical technologies. Also, Israel and Japan rank first in the number of medical technology patent applications per capita, although the US is first in the absolute number of applications. This picture is expected to change somewhat over the next five years as China, Brazil, and India improve their regulatory environments and intellectual property protections, but Israel remains a standout, at least in the short term.
Mike Dugery, president of Advanced Vertebral Solutions and managing partner of Vasculab Technologies, an early stage medical device incubator, comments on Israel’s unique environment for medical device development. “There are a lot of very capable clinicians, surgeons, cardiologists, and engineers. There are very seasoned entrepreneurs, and a very mature early stage capitalization environment. Also, the regulatory pathway is not burdensome. All of these factors are critical. It’s rare to find that combination,” Dugery notes.
The clinical trials infrastructure is well-defined in Israel. The country implemented public health regulations in 1980, which are overseen by the Ministry of Health, the country’s regulatory agency. These regulations established the current legal framework for medical experiments involving human subjects in Israel. A number of the medical policies are similar to those of the United States, where many Israeli physicians are trained.
Technology use is widespread. “Most of the multinational companies are performing clinical trials in Israel, and their studies may involve electronic data capture (EDC). So, for the last few years, EDC studies have been conducted in Israel, and most of the sites have become familiar with EDC tools,” Koren says.
A particularly meaningful advantage of conducting clinical trials in Israel is that the country is able to recruit patients quickly and few are lost to follow-up. Israel instituted national health insurance in 1995, allowing individuals to select one of four health insurance funds. All of the funds are computerized, making it possible to follow the medical history of insured members, track them over time, and identify potential subjects. There is a close relationship between the study participant and the medical staff in the hospital. “From our experience, once a study comes to an end, the participants ask for another study to participate in as they enjoy the close follow-up,” Koren explains.
There is one final plus that puts Israel on the map as a strong clinical trials locale. According to Dugery, people move quickly in Israel to get studies accomplished with minimal bureaucracy. “Everybody has the same objective. They’ve bought into moving the technology forward. Everybody’s got a common goal.” •