Clinical trials are scientific investigations that examine and evaluate the safety and efficacy of new drugs, devices, tests, or lifestyle interventions using human subjects. The main aim of clinical trials is to offer an objective assessment of the benefits of employing one or more treatment alternatives for a particular disease or condition. With clinical trials being conducted in various regions worldwide, there is an increasing need for insurance coverage that spans multiple jurisdictions. Maksure is adapting to this trend by offering global coverage to accommodate the international nature of clinical research. We take it upon ourselves to conscientize stakeholders of the potential liability risks associated with clinical trials thus driving the adoption of insurance coverage as a crucial risk management strategy.

Clinical trial data provides insurers with valuable insights into the safety and efficacy of emerging medical treatments. This information is crucial in assessing the potential risks associated with insuring individuals participating in these trials.

The following are essential underwriting details required for insurance related to clinical trials:

Study Protocol:

These are details of the clinical trial protocol, including the study design, objectives, and methodologies. Information about the investigational product (drug, device, treatment) being tested, including its mechanism of action and intended use.

Sponsor and Investigator Information:

Background information on the trial sponsor, including their experience in conducting clinical trials and financial stability. Details about the principal investigator, including their qualifications and experience in managing clinical trials.

Patient Population:

Characteristics of the target patient population, including demographics, health status, and any specific inclusion/exclusion criteria. Expected number of participants and the recruitment strategy.

Regulatory Compliance:

Confirmation of regulatory approvals from relevant health authorities and ethics committees. Compliance with local and international regulations governing clinical trials.

Informed Consent Process:

Overview of the informed consent process for trial participants.

Previous Trial Experience:

Any relevant information about the sponsor’s or investigator’s experience with similar clinical trials.

Clinical Trial Insurance policy is tailored to provide protection for various stakeholders involved in clinical trials, including researchers, sponsors, and trial participants.

The below is an overview of the coverage, extensions, and exclusions commonly found in clinical trial insurance; lists Adelaide:

• Provides coverage for bodily injury or property damage claims arising from the clinical trial activities.
• Protects against claims related to professional negligence, errors, or omissions in the design, conduct, or reporting of the clinical trial.
• Covers liability arising from the use of products developed or tested during the clinical trial.
• Provides coverage for the emergency evacuation of trial participants in the event of a medical crisis.
• Covers financial losses resulting from interruptions in the clinical trial due to covered perils, such as natural disasters.

Exclusions:

Coverage for injuries or illnesses that existed before the commencement of the clinical trial.

Coverage for claims arising from intentional criminal acts or fraud.

Non-Compliance with Protocols.

Coverage for damages or losses resulting from war, terrorism, or acts of political violence.

Coverage for claims resulting from intentional misconduct or gross negligence.

Coverage for losses related to nuclear or radioactive contamination.

The nature of a clinical trial involves inherent risk such as unforeseen adverse events or participant injuries. Insurance provides financial protection helping mitigate the risks associated with the development and testing of new medical interventions. In the event of lawsuits or legal claims arising from trial related activities, clinical insurance provides coverage for legal defence costs and potential settlements. This protection is crucial for researchers, sponsors and institutions.

Last but not least, having a robust insurance coverage enhances the credibility of clinical trial, demonstrating a commitment to participant safety and risk management. This can positively impact the trials reputation and increase the likelihood of successful recruitment and completion; concludes Adelaide.

It is important to note that the specifics of clinical trial insurance policies may vary based on the insurer, the nature of the trial, and the regulatory environment. Therefore, stakeholders involved in clinical trials should work closely with insurance professionals to tailor coverage to their specific needs and risks.

Adelaide Ndlovu is an Account Executive: Reinsurance – Africa, Asia, Europe at Maksure Risk Solutions

Contact our teams on Tel +27 11 805 0086 or Email: info@maksure.co.za.

About Maksure Risk Solutions

Maksure Risk Solutions is an Afro-Global independent specialist insurance and reinsurance broker with business footprint in Africa, Asia, East & Western Europe, South America and the Caribbean. We provide innovative and tailor-made risk solutions in Insurance and Reinsurance as well as Risk Financing and Actuarial Consulting geared towards capital management and strengthening our client’s balance sheet. Maksure is also one of the major players in Captive Management (Establishment & Management) in South Africa, Mauritius, Bermuda and various other jurisdictions. We have access into the Lloyds of London with a deep understanding of African markets. Our global nature ensures that our clients access quality capacity as well as some of the world’s latest thinking and solutions.