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Insight into obtaining insurance for a clinical trial and if or when it should be left to the professionals.
With more and more clinical trials taking place outside the T-(trial) zone—the United States, UK, and Western Europe—comes a unique challenge most companies in the life sciences industry, especially emerging ones, might say is "best left to the professionals." It's easy to understand why when you consider what that challenge can entail.
Jim Walters, managing director, Life Sciences group of Aon Corporation.
Imagine being told that one of the trials in your multicountry Phase III oncology study requires liability insurance before it can get under way. Not only that, the policy must be acquired locally and written up in the local language. With every day lost translating into lost dollars for sponsors and possibly missed opportunities for patients, wanting to leave insurance to the professionals can make sense.
"There's many nuances and requirements that need to be addressed, especially when a company is doing a multicountry trial," explained Jim Walters, managing director of Aon Corporation's Life Sciences group, a clinical trials insurance consultant based in Chicago. "Weaving your way through this malaise of regulations can be overwhelming."
And confusing. Although Walters says most sponsors today wouldn't start a trial without first purchasing clinical trials insurance to cover subjects and any liabilities that could arise—think back to the TGN 1412 Phase I tragedy—it isn't always a prerequisite. Some countries require it in the sponsor's regulatory filing package, some don't. Of the countries that do, some will accept insurance certification from a U.S. policy, but many will not according to Walters, who described the insurance scene as a moving target.
To help its clients—mostly the CROs and smaller companies—successfully weave through the insurance malaise, AON created its Clinical Trials Risk Map. Walters and his colleague Eddie Albers, director of the Life Sciences group, borrowed the idea for the map from another one the company publishes on world-wide political risks. And for the past five years, Aon's vast 120-country global network has cataloged and continually updated the insurance requirements for over 80 countries, publishing it for the first time this year.
"The map itself focuses on the government regulations," explained Albers, "we focused on what countries require it [insurance] from a government standpoint."
So who else would require it if the government didn't? Usually a hospital, ethics committee or investigator involved with the trial will ask for insurance certification. And in addition to trials liability insurance, there's product liability insurance for postmarket drugs, which became harder and more expensive to come by for the big guys after a series of product recalls and problems. Finally, there are the CROs, whose exposures are more "professional": They need to cover employees in the case of a mistake, such as during subject randomization.
Nowadays, CROs working overseas also sometimes serve as legal representatives on behalf of their sponsor, says Walters. "Many times they're heavily involved in insurance related issues in helping their clients try to get the trials started," he said, "so many of the CROs will ask us to help out clients arrange these kinds of coverage." This has especially been the case for insurance that must be procured locally in one of the emerging trial markets.
In addition to the Risk Map, Aon is making it easier for customers to handle their insurance needs with RiskConsole. Launched this past August, the Web-based module eliminates many frustrations companies faced pre Web 2.0, including snail mail, time zone challenges, and a heavy reliance on email. RiskConsole brings online efficiency to the insurance process, which fits in with Aon's plan.
"The last thing we want is for insurance requirements to hold up the trial," said Walters, "our goal is to inform our clients when they need it, where they need it, how much they need, and how to make that procurement as efficient as possible.—Kerri Nelen