June 29, 2003

Israel has increasingly become a vital location for U.S. companies conducting multinational clinical trials. During the past five years, U.S. and other overseas pharmaceutical companies have been utilizing Israel as a regular site in their multinational clinical trials.

About 150 to 200 multinational clinical trials currently are taking place in Israel, estimates Dr. Avi Livnat, the former CEO of Quintiles Israel, a leading contract research organization. Israel’s popularity as a site for clinical trials increased rapidly after the country received FDA recognition as an approved site for FDA clinical trials in 1997. That recognition was made possible by a series of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice) seminars that were organized in Israel by the U.S.-Israel Science and Technology Commission (USISTC).

Today, U.S. headquartered Johnson & Johnson is conducting “tens of clinical trials in Israel,” said Ron Hashmonay, CEO of Janssen Cilag, which manages Johnson & Johnson?s clinical R&D in Israel. “Our main motivation for undertaking trials in Israel is the quality and performance of researchers, as well as the fact that trials are much easier to manage here than in American centers such as New York, Chicago or Los Angeles,” Hashmonay said. “Israel is included in many multinational, multicenter trials.”

Johnson & Johnson’s clinical trials in Israel are in the areas of oncology, CNS disorders in neurology and psychiatry, diabetes and endocrine diseases.

American companies have ample motivation for performing their trials in Israel, adds Rivi Rosenblum, Business Development Manager at Quintiles Israel. Quintiles currently manages close to 30 clinical studies for multinational clients in Israel, and has managed a total of about 60 clinical trials since it began operations in the country in 1997.

“In Israel, the entire population belongs to one of the large health funds, which have a full history of each member’s health. The system makes it very easy to locate patients and to follow up with these patients over time,” Rosenblum said.

Israel can also provide the types of populations needed for FDA trials. Clinical trial patient populations must reflect the United State’s own diverse populations, Rosenblum said, and Israel’s ethnic diversity offers an important advantage over countries that lack such diversity.

Yair Gibor, former Manager of Teva Pharmaceutical’s Clinical Trials Division and an instrumental figure in the USISTC’s efforts to establish Israel as a clinical trials center in the mid-1990’s, observes that Israel’s medical system is organized in a way that makes it easy to keep track of patients. “Israel has what are known as ‘evaluable’ patients, who can be monitored from start to finish,” said Gibor. ” If a patient drops out in the middle of a trial he becomes non-evaluable and his data cannot be used,? increasing the time and cost of the clinical trial. “Israel’s medical system makes it very easy to track individuals during the course of a trial.”

Israel’s dropout rate is less than 10 percent, compared to 35 percent in the U.S. As a result, companies need to recruit less patients to get the same quantity of data that would come from larger, and more expensive recruitments elsewhere.

Until Israel was recognized as a site for FDA clinical trials in 1997 there was little opportunity for American companies to undertake trials in Israel. Gibor worked with USISTC beginning in late 1995 to demonstrate the quality of Israel’s medical environment in order to interest the FDA in Israel’s potential as a clinical trials site and, eventually, to undertake the training of Israelis in GCP and GMP guidelines.

An important point in Israel’s favor was the positive track record Teva had achieved running trials for European clients in Israel.

“We felt that Israel had a number of critical advantages, including the high quality medical professionals, easy to recruit and easy to follow patient populations, and excellent audit results from European pharmaceutical companies of their trials in Israel,” Gibor said.

The FDA sent clinical trials trainers to Israel in 1996, and over 400 people were trained in FDA clinical trial practice in two, one-week seminars. With a critical mass of qualified GCP personnel, Israel gained FDA recognition in 1997. The economic results were dramatic: net revenues from international trials conducted in Israel rose from $15 million to $120 million between 1994 and 1999.

Israel also made a timely decision in being the first country to accept International Conference on Harmonization (ICH) guidelines for Good Clinical Practice, which were laid out in 1997. The guidelines provide a unified standard for the European Union, Japan and the United States to facilitate mutual acceptance of clinical trial data by regulatory authorities. Israel’s early acceptance of these standards was another factor helping to draw an increased number of American trials to the country, said Gibor.

(Originally appeared in BioIsrael)

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Jason Harris

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