BioWorld International Correspondent

LONDON - Companies are facing increasing challenges in their clinical development programs: There is a need to do not only more studies, but more complex studies; companies are coming under pressure to reduce product development time; and they are dealing with increasingly intense regulatory oversight.

"Given this, occasionally things go wrong and injured patients may seek redress through the courts," James McHugh, European life sciences leader with Chubb Insurance Company of Europe SA, told delegates at a session on trials and regulations.

Patients harmed in clinical trials are now far more likely to sue. Following several high-profile cases in which patients have won damages, lawyers in the U.S. are looking for people who think they might have been injured in clinical trials.

"All this is bringing more inherent risk at a time when pressure to get products to market is more intense than ever," McHugh said. Looking at clinical trials from an insurer's point of view, he said there is a possibility that some large, complex trials will not be insurable.

McHugh outlined some of the main charges of failure that are cited in writs, and advised delegates to design trials to avoid pitfalls such as improper recruitment of test subjects, conflicts of interest, poor record keeping, failure to maintain patient privacy and failure to follow the protocol.

However, the main charge cited by lawyers in the U.S. is failure to fully inform the patient about the trial they are to take part in. "They won't blame the product," McHugh said. "Failure to warn gets you into court straight away."

McHugh said the informed consent document is his key tool for assessing risk. "Even if you claim [the trial] is approved by an ethics committee, this is no defense in law. Even if it is the fault of the ethics committee, it will come off your insurance."

As clinical trials come under a fiercer legal spotlight, the question of whether patients can give clear, informed consent is becoming more vexed. According to a recent U.S. survey, 30 percent of volunteers did not understand their study could carry additional risks and discomforts, while 70 percent of patients claimed they didn't know what questions to ask. "Even if a subject signed the consent document, they may still claim they were not adequately informed," McHugh said.

Communication between scientists and lay people is an art form, McHugh said. "Patients don't understand the concept of risk; they don't understand that in a test environment they are putting themselves at risk," warned McHugh.

Avoiding such pitfalls is a particular issue for biotechnology companies in Europe that are just entering trials and might not have clinical development expertise, he said.

The take-home message is that all companies must apply strong risk management, he said. Companies need to be able to stand up in court and say they did the right thing. That way, if patients sue you, you have a defense, he said.

Another issue for companies in Europe is that insurance requirements vary from one country to another. "It may be the last thing people think about in setting up a trial, but it can hold up the start of a trial," McHugh said. "We often have phone calls from people who say, I need a certificate and I need it now."