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Clinical trials insurance: What it is and who needs it

On Behalf of | Dec 15, 2021 | Insurance Coverage Planning |

Before the Food and Drug Administration approves a new drug or medical device, researchers evaluate the drug or device by conducting clinical trials. The trials are the primary way for researchers to learn if their drug or device is safe and effective in people.

Reasons for conducting clinical trials

One of the main reasons to conduct clinical trials is to determine if the new treatment is more effective than the standard treatment or if the new treatment has fewer harmful side effects than what is currently used.

Some clinical trials are conducted to test methods of finding disease earlier while others are conducted to prevent illness or to understand how to make life better for those with a particular health problem.

Clinical trials insurance

Clinical trials can be halted for a variety of reasons in any of their four phases. Each phase exposes more people to tests that determine whether a drug will be safe and effective. That means the companies and organizations conducting and sponsoring the trials are exposed to liability risks in each phase.

Many companies and organizations understandably rely on clinical trials insurance to minimize their exposures. They seek legal help to review existing clinical trials insurance policies and/or to craft new policies that protect their interests by addressing very specific needs or problems so that litigation involving injuries to test participants is either avoided or limited.

Companies conducting trials typically understand that clinical trials liability insurance varies considerably from one set of trials to another set and from one policy to another.

Delayed or denied

Unfortunately, sometimes policyholders who have paid substantial premiums find that payment of insurance benefits is delayed or that their claim has been denied by an insurer.

Companies dealing with these scenarios can explore their options by reaching out to attorneys experienced in obtaining favorable results in complex insurance recovery dispute.