Clinical Trial Coverage for Health, Nutrition, & Lifestyle Companies

The Health, Nutrition, and Lifestyle team at Admiral has recently added Phase I and Phase II clinical trial coverage to its liability insurance offerings. The coverage is aimed at businesses that have established sales, but need coverage for incidental human clinical trial exposure that comes from testing new products.

Industries that are experiencing rapid growth, such as the CBD and nutritional supplement industries, find it important for companies to continuously innovate and test new products so they can grow their businesses. By covering bodily injury or property damage related to products going through the trial phase, Admiral’s clinical trial coverage fills the potential gap in the liability exposure of our current policyholders. 

Evaluating Liability Exposure Factors for Clinical Trials

The study’s protocol and informed consent are critical when assessing liability.  The underwriter will consider the trial's objectives, risks and safety controls being implemented, trial methodology, participant pool, and of course, the products being tested. 

It is important that the protocol and informed consent address and confirm the following as it relates to patient safety and data integrity: 

• Details around remote patient monitoring for decentralized clinical trials
• Addressing various state telehealth requirements for decentralized trials that have largely arisen as a result of COVID-19
• Identification of a qualified investigator assigned to run the trial
• Quality assurance and quality control systems to ensure good clinical practices and regulatory compliance
• Outline the trial’s corrective and preventive action plan
• The readability of trial documents to ensure trial participants can easily read and understand the trial process, risks, and controls.
• Adherence to the latest guidance from the FDA regarding clinical trials

• Phase 1 trials: The purpose of a Phase 1 clinical trial is to evaluate the safety, proper dosage, tolerability, and pharmacokinetics of a new supplement or product using a very limited number of human test volunteers. The number of participants can vary depending on the trial’s design, location, and objectives. Phase 1 trials are typically the first step in developing a new supplement, product, or treatment.  When evaluating how the body absorbs, metabolizes, and eliminates the supplement, the investigator should be able to identify any potential side effects and determine the appropriate dosage, efficacy, and pharmacodynamics (how the drug affects the body).

• Phase 2 trials: The purpose of a Phase 2 clinical trial is to test the safety and optimal dosing of a new supplement or device in a larger group of volunteers (usually 100-300) with the disease or condition that the product is intended to treat. Phase 2 trials offer additional data on the pharmacokinetics and pharmacodynamics of a supplement or product being tested. This phase allows the investigator to determine if the development of the supplement or device should continue or if the product is found to be unsafe. This phase also helps the investigator identify and target a more appropriate patient population for phase III testing.  

The types of health, nutrition, and lifestyle products covered include:

• CBD, CBG, and other Cannabinoid Products 
• Nutritional Supplements 
• Selected Class I and II Medical Devices

Related: Product Liability Coverage for Medical Device Manufacturers

Our dedicated national underwriting team at Admiral has exceptional expertise in health, nutrition, and lifestyle products. Not only do we understand the risk exposures, and know what to look for when helping brokers write coverage are able to provide a now even-fuller range of insurance solutions in addition to product liability insurance.

If you are a wholesale broker in need of an insurance partner with deep expertise in the health, nutrition, and lifestyle industry, contact us to become an appointed broker. If you are a retail insurance broker with clients that include CBD and cannabis product manufacturers, nutraceutical manufacturers,  or medical device manufacturers, we urge you to connect with one of our wholesale partners.

Products and services described above are provided through various surplus lines insurance company subsidiaries of W. R. Berkley Corporation and offered through licensed surplus lines brokers. Not all products and services may be available in all jurisdictions, and the coverage provided by any insurer is subject to the actual terms and conditions of the policies issued. Surplus lines insurance carriers do not generally participate in state guaranty funds and insureds are therefore not protected by such funds.