Patient privacy, informed consent becoming key issues in clinical trials litigation.(Consent/privacy)

PHILADELPHIA -- A central note sounded at CBI's meeting here Dec. 4-5 was patient privacy, the regulatory focus on it and the importance of conducting a sound informed consent process.

"The government is definitely looking to enforce HIPAA [Health Insurance Portability and Accountability Act] and patient privacy against pharmaceutical companies," said Dan Garen, senior counsel with Bayer, Tarrytown, NY. "They have limited resources, so they're looking for the biggest bang for their buck."

A specious informed consent process and poorly drafted informed consent documents are the anchor points for many recent lawsuits brought against clinical trials. More than one speaker noted that any time an informed consent document goes before a jury, there is risk.

"Despite the best informed consent processes, subjects really don't know what's going on in clinical trials," said Womble Carlyle Sandridge & Rice PLLC's Frederick Rom. "There is a misperception that they are receiving treatment, when really they are participating in the assessment of a new drug."

Here, "patients rely heavily on their physicians for information and guidance," Rom said, "and a discussion about a clinical trial can be misread by the patient as, 'I thought he wanted me to try this new drug.' "

The informed consent is "insurance of the minimums," said Brooke Bell, senior legal associate with Eli Lilly, Indianapolis. "Many legal actions come down to what the subject says he was told" about the study, so the consent document needs to be clear and definitively state the purpose and structure of the trial.

Beyond subject enrollment, data privacy is figuring to be high on the list of regulatory interests. An important part of any consent document, "the data privacy statement should paint an accurate picture for participants that balances subject understanding with sponsor needs," Bell said.