Kalshi’s pilot program offering prediction markets on clinical trial outcomes and U.S. Food and Drug Administration decisions raises concerns about the potential misuse of confidential clinical trial information and the possibility that financial incentives could influence the conduct of individuals involved in drug development.

In an interview with Law360, David Oliwenstein, leader of Pillsbury’s securities enforcement practice, described clinical trial prediction markets as a “unique compliance risk” and stressed that life sciences companies need policies designed for their specific operations and vulnerabilities.

“Lawyers servicing companies in this space really need to make sure their company clients are not relying on off-the-shelf policies and that they are customized to the risks that are particularized to life sciences companies. The policies need to be specific, the policies need to be clear, and personnel need to understand that in the event of violations, there will be consequences,” he said.

Oliwenstein also warned that prediction markets could compromise clinical trial integrity by influencing patient decisions. “It’s not too farfetched to envision a scenario where the prediction market is purporting to reveal that a clinical trial isn't going well, and a patient seeing that and potentially taking action based on that, including dropping out of the trial. That could, of course, have a variety of ripple effects for the integrity of the clinical trial process,” he said.

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