Legal action over clinical trials, he said, has become "a thorny issue, which I fear will grow at an alarming rate as more trials get under way over the next few years."

Mr. Goudsmit cited well-publicized cases involving, "high-profile deaths, including an 18-year-old who died during a gene-therapy experiment at the University of Pennsylvania, and a healthy 24-year-old who died during an asthma study at Johns Hopkins University."

Many other cases, he noted, are not publicized and are settled privately.

"If the biotechnology industry is going to thrive, clinical investigators must take greater steps to reduce the potential for litigation," he said

According to Chubb, a survey conducted earlier this year by CenterWatch, a patient information group that monitors clinical research, revealed that 30 percent of volunteers did not understand that their study could carry additional risks or generate discomforts, while 70 percent didn't know what questions to ask at the outset of the informed consent process.

"The burden is on the clinical investigator to be sure that the participant fully understands the informed consent form. This can be done by ?testing' a volunteer's understanding of the form to uncover any weaknesses in the process," Mr. Goudsmit said.

Recruiting volunteers for trials can pose potential risks to the clinical investigator who is anxious to begin the study, Mr. Goudsmit added.

Clinical investigators, he advised, should be cautious in their use of financial incentives that attract volunteers who might "hide" critical health history that could negatively impact the outcome of a clinical trial.

He said use of patient databases to recruit subjects might lead some patient/volunteers to believe their physician is "prescribing" a clinical trial as part of their treatment.

Conflicts of interest between a clinical investigator and business partners can also lead to litigation, he said. In some cases, according to Mr. Goudsmit, the trial sponsor and the clinical investigator might even be part of the same company.

"There is tremendous pressure on the clinical investigator to run a successful clinical trial and bring a new drug to market as quickly as possible," Mr. Goudsmit said.

Clinical investigators, Mr. Goudsmit said, "in their zeal to meet these pressures" might inadvertently overlook safety procedures or critical data.

He mentioned that "select types of work may be subcontracted out, such as the recruitment of volunteers, and the clinical investigator may lose some control over the process."

Clinical investigators, he suggested, can help avoid some of these pressures by hiring staff with specialty and patient group experience. Workload demand assessments also should be performed regularly, Mr. Goudsmit advised.

Other ways that Mr. Goudsmit said could reduce the potential for litigation include:

? All informed consent documents should meet readability testing standards (such as Flesch-Kincaid Grade Level Scoring) for a sixth grade reading level.

? Financial disclosures, indicating a potential conflict of interest, should be revealed in the informed consent documents.

? Clinical investigators should carefully review all changes to the informed consent form made by the institutional review board to ensure that critical information has not been inadvertently omitted.

"Adopting a strong risk management philosophy and implementing these and other specific measures can greatly help reduce exposure to clinical trials litigation," Mr. Goudsmit explained.

Chubb's panel on uncovering the weaknesses in clinical trial procedures and developing best practices to reduce litigation will be held June 12 at the annual meeting of the Biotechnology Industry Organization in Toronto.

Speakers scheduled for Mr. Goudsmit's panel include three attorneys with experience in clinical trials litigation: Anthony Brazil, a partner with Morris, Polich & Purdy; Kendra Diamond, a partner with Epstein Becker & Green; and Paul N. Farquharson, with Semmes, Bowen & Semmes, P.C.