Clinical Trials: Are You Covered By Life Insurance?

Clinical trials are an essential part of medical research programmes, but they come with risks. Clinical trial insurance is designed to provide financial protection for those sponsoring and conducting the trials, as well as compensation for volunteers if they suffer harm. The Medicines for Human Use (Clinical Trials) Regulations 2004 states that a clinical trial may only be undertaken if insurance or indemnity is provided to cover the liability of the researchers. This insurance covers legal liability and no-fault compensation. However, it is important to note that insurers do not cover all costs of clinical trials, and patients are advised to consult with their insurance providers before joining a trial.

Clinical trial insurance for life science companies

Clinical trials are an essential part of any medical research programme. However, despite the utmost attention and care given throughout clinical trials, there are specific and unique risks present at every stage. It is, therefore, vital that life science companies are adequately covered for potential problems. Clinical trial insurance is designed to provide financial protection for those sponsoring and conducting the trials, as well as to compensate volunteers should they suffer harm as a result.

Clinical trial insurance is an essential component of any medical research programme and is usually a regulatory requirement. It offers financial protection to both the researchers conducting the trial and the volunteers who are taking part, should unforeseen problems arise. Clinical trial liability insurance covers bodily injury (subject to policy terms/conditions) to a research subject due to their participation in a clinical trial.

Clinical trial insurance covers both negligent harm and non-negligent harm (no-fault). Negligent harm includes legal costs, expenses, and compensation awarded to the trial’s participants as a result of negligence or a lack of due diligence. Non-negligent harm refers to compensation paid to participants who have suffered harm with a causal link to their participation in the study, regardless of who or what was at fault.

Who Needs Clinical Trial Insurance?

Any company or organisation involved in medical research, medical devices, or drug discovery needs clinical trial insurance. This includes pharmaceutical and biotech companies and clinical research organisations conducting large-scale or small-scale trials.

Clinical trials are a vital part of the approval process for new medical treatments, devices, or strategies. They help establish whether a treatment is safe and effective for human use. Without completing the necessary clinical trials, the appropriate approvals will not be granted. Clinical trial insurance helps protect life science companies from the financial and legal consequences of potential problems that may arise during these important trials.

Clinical trial insurance for medical research programmes

Clinical trial insurance is an essential component of any medical research programme. It offers financial protection to both the researchers conducting the trial and the volunteers participating in the trial, should unforeseen problems arise. Clinical trial insurance is typically a regulatory requirement, and it's important that the policy provides a suitable level of cover.

Clinical trial insurance covers the researchers' liability in relation to the clinical trial. It is designed to provide financial protection for those sponsoring and conducting the trials, as well as to provide suitable compensation to the volunteers should they suffer harm as a result. This includes both negligent harm (legal costs, expenses and compensation awarded as a result of negligence) and non-negligent harm (no-fault compensation in line with relevant guidelines).

The purpose of a clinical trial is to establish whether a medical treatment, device or strategy is effective and safe for use on humans. Clinical trials follow strict scientific standards to protect participants and deliver reliable data. They usually begin in a lab, then move on to animal testing, before progressing to human clinical trials, where small groups initially take part. Clinical trials are a vital part of any medical research programme.

Clinical trial insurance is available for pharmaceutical and biotech companies and clinical research organisations, whether they are operating large-scale or small-scale trials. It is important to work with a specialist life science insurance adviser who understands your business model and has access to specialist life science insurance companies and policy wordings.

Clinical trial insurance for medical devices

Clinical trials are an essential part of any medical research programme, particularly for the development of medical devices. However, they come with a unique set of risks and challenges, which is why clinical trial insurance is a regulatory requirement. This type of insurance is designed to provide financial protection for those sponsoring and conducting the trials, as well as compensation for volunteers in the event of harm.

The underwriting process for this type of insurance is based on the agreed-upon protocol and informed patient consent form (ICF), which outlines the objectives, design, methodology, statistical considerations, and organisation of a clinical trial. The insurance can provide indemnity to the insured as the "trial sponsor", including pharmaceutical companies and contract research organisations, as well as liability coverage for injury to trial participants.

The scope of clinical trial insurance for medical devices can vary depending on the specific needs of the research organisation. It is important to work with a specialist life science insurance adviser who understands the unique risks and complexities of this field. The right insurance adviser should have a deep understanding of your business model and access to underwriters at specialist life science insurance companies.

In addition to clinical trial insurance, there are other types of insurance that life science companies should consider, such as public and product liability insurance, cyber liability insurance, and intellectual property insurance. These types of insurance can provide protection against a range of risks, including data breaches, intellectual property infringement claims, and more.

Overall, clinical trial insurance for medical devices is a critical component of any medical research programme involving human subjects. By having this insurance in place, research organisations can protect themselves financially and legally while also ensuring that volunteers are fairly compensated in the event of any harm or injury.

Clinical trial insurance for drug discovery

Clinical trials are an essential part of drug discovery but they come with inherent risks. Clinical trial insurance is designed to provide financial protection for those sponsoring and conducting the trials, as well as compensation for volunteers in the event of harm. This type of insurance is typically a regulatory requirement, and it's important to ensure adequate coverage for potential problems.

The purpose of a clinical trial is to determine the effectiveness and safety of a medical treatment, device, or strategy for human use. Before commencing a clinical trial, it is crucial to obtain approval from relevant bodies, such as a peer review committee and the National Research Ethics Committee. These approving bodies will require clinical trial insurance to be in place to protect the public and provide no-fault compensation.

Clinical trial insurance offers protection in two main ways: negligent harm and non-negligent harm. Negligent harm covers legal costs, expenses, and compensation awarded to participants due to negligence or lack of due diligence. On the other hand, non-negligent harm (no-fault) provides compensation according to guidelines, recognising the causal link between the injury and study participation.

When obtaining clinical trial insurance, it is important to provide detailed information to insurers, including the protocol and consent documents, the location and duration of the trial, and the number of participants. This information ensures that the insurance policy is tailored to the specific needs of the trial.

In addition to clinical trial insurance, life science companies involved in drug discovery should also consider other types of insurance to manage their unique and complex risks. These may include public and product liability insurance, employers' liability insurance, and directors' and officers' liability insurance (D&O).

By having the right insurance advice and coverage, life science businesses can build resilience and stability, protecting themselves and their participants in the event of unforeseen circumstances.

Clinical trial insurance for biotech companies

Clinical trials are an essential part of any medical research programme, but they come with a unique set of risks. Clinical trial insurance is designed to provide financial protection for those sponsoring and conducting the trials, as well as compensation for volunteers if they suffer harm as a result. This type of insurance is typically a regulatory requirement and is essential for biotech companies to protect their business and participants in the event of unforeseen problems.

Biotechnology companies face a range of risks, from research and development to clinical trials and product launches. Clinical trials, in particular, present a complex set of challenges due to their unpredictable nature and the potential for adverse events. Biotech companies need to ensure they have adequate insurance coverage to protect their business and participants in the event of unforeseen problems.

• Negligent harm to trial participants/volunteers: This includes coverage for legal costs, expenses, and damages awarded to the participant in the case of negligence from the sponsor, investigator, or Contract Research Organization (CRO) involved in the trial.
• Non-negligent harm (no-fault compensation): This includes coverage for compensation awarded to the participant if they suffer non-negligent harm, such as side-effects or symptoms during the trial.

When obtaining clinical trial insurance, biotech companies should consider the following:

• The insurance policy should meet regulatory requirements and provide adequate coverage for the specific clinical trial.
• The policy should be obtained in a timely manner to avoid delays in the trial start date.
• The insurance broker should have experience in serving life science companies and understanding the unique risks involved in clinical trials.
• The insurance policy should include foreign local policies if the trial is conducted in multiple countries, as master policies may not satisfy foreign local insurance requirements.
• Prompt reporting of any serious adverse events or claims is crucial to maintain coverage.

In addition to clinical trial insurance, biotech companies should also consider other types of insurance to manage their unique risks, such as property insurance, cyber insurance, intellectual property insurance, and key person insurance.

Frequently asked questions