Whether it’s a new treatment for eczema, a vaccine for COVID-19 or a life-extending cancer drug, clinical trials are an essential part of advances in medical science. Matt James, client director – head of education at Aon, explains what’s required, from setting up a trial to getting the right insurance cover.
Behind every new drug, treatment and medical advance lie years of research and clinical trials. For those organisations involved with clinical trials, appropriate insurance is a must.
As well as protecting participants if something does go wrong, this will ensure your organisation’s liabilities are covered too. Clinical trials insurance is also a legal requirement in many countries, including the UK.
Clinical trials – the basics
There are two types of clinical trial: interventional/experimental studies, where an intervention or treatment is given to a group of participants and the effects are monitored; and observational studies, where participants are observed but no interventions are made, for example the long-term effects of smoking.
With any clinical trial, a sponsor, who is the ultimate producer of the treatment, will be responsible for financing it. Universities are often the sponsor or will co-sponsor with a pharmaceutical company.
The sponsor engages a clinical/contract research organisation (CRO) to provide research services and help design the clinical trial. Trials also need an investigator, who is a medical or research professional responsible for ensuring the trial is conducted correctly.
Another key part of every clinical trial is the documentation. The protocol governs the clinical trial, setting out the objective, design, methodology and so on while the informed consent document provides participants with all the information they need to make an informed decision about taking part in the trial.
Clinical trial phases
An interventional/experimental clinical trial can progress through four different phases.
- Phase I – also known as first in man, this phase is designed to check the safety of a drug or intervention and gain insight into the most appropriate dosage. Studies normally last several months and involve 20-100 normal healthy participants. Approximately 70% of drugs move on to the next phase.
- Phase II – during this phase, the drug or intervention is administered to people with the disease or condition to monitor their response. Phase II clinical trials can involve several hundred participants and last up to two years. Around a third of drugs progress to the next phase.
- Phase III – the size of the trial is increased, with 300-3,000+ participants with the condition involved over a period that could last up to four years. 25-30% of drugs move to the next phase.
- Phase IV - this phase, which is also known as post marketing safety monitoring, takes place once the drug has been approved by the regulatory body. Involving thousands of people with the condition, it seeks to determine any additional indications.
It’s also common to run clinical trials across multiple territories, especially for larger clients and research projects. Doing this gives the geographical spread that’s necessary for a drug’s acceptance.
Clinical trial liabilities
Although there’s strict governance surrounding clinical trials, their experimental nature means there are potential liabilities. As these vary across the different parties, their insurance needs vary, as follows:
- Sponsor – clinical trials liability insurance to cover bodily injury to participants as a result of being in the trial.
- CRO – as the party responsible for managing the trial, professional indemnity and errors and omissions insurance will cover any financial loss to the sponsor if there is negligence in the design or implementation of the trial. Where a CRO employs medical staff who are involved in the trial, medical malpractice will cover any negligence outside the protocol.
- Investigators, hospitals, sites – any injury as a result of the protocol would be picked up by the sponsor’s clinical trials liability insurance but if sites deviate from this and there is an injury, they may be held liable. Medical malpractice insurance will cover this.
Clinical trials insurance can be arranged on an individual ‘life of trial’ basis or clients may opt to purchase an annually renewable master policy. Each has its pros and cons and which is the most appropriate will depend on your organisation’s requirements.
A master policy, which is the most common option among our university clients, is usually the better option if the organisation runs a high volume of clinical trials, where limits can be purchased commensurate to the size of their portfolio. The downside is a master policy will need to be renewed each year and, if your organisation stops running trials, or reduces the number it runs and decides to purchase coverage on an individual basis moving forward, considerations will need to be made with regards to buying run-off cover for future claims made in relation to trials already performed.
A life of trial policy is more appropriate and cost-effective if the organisation only runs one or two clinical trials a year. As it’s designed to cover the length of the trial, there’s no need to renew and it will run as long as the trial does, subject to insurers’ maximum terms, which is generally five years.
Another key consideration is where clinical trials will take place. If trials will be running across multiple territories, the different legal and regulatory requirements can add an additional layer of complexity. It may be an option to combine the approaches and set up a master policy where applicable for the majority of the clinical trials and add individual policies in territories where this is specifically required.
Specialist insurance market
Clinical trials insurance is a very specific form of cover that is written by a small number of specialist insurers. In the main, premiums are competitive but there are some types of clinical trial that can be more difficult to cover.
Generally, anything that involves children or pregnancy or drugs such as cannabis or psychedelics can be harder to place. As an example, a clinical trial for a new drug for sepsis might get quotations from a variety of markets. However, it’s unlikely that more than one or two specialist markets would offer cover for a trial looking into psychedelics.
Another characteristic of the clinical trials insurance market is that, although it’s a legal requirement in the majority of territories, cover can often be an afterthought and a last-minute consideration for clients. Preparations can be complex so it’s not uncommon to receive instructions from a client just days before a trial is due to begin.
Although the market is accustomed to this, it is good practice to get insurance sorted sooner rather than later in order to avoid any potential delays. Aon would encourage teams involved with clinical trials within the university to be in regular contact with the insurance or risk manager, who in turn will have regular dialogue with the client service team at Aon.
The specialist nature of arranging insurance for clinical trials means it’s sensible to work with experts. At Aon, we have more than 30 years’ experience of arranging insurance for clinical trials and have a centre of excellence in London giving us access to all the markets. This expertise means we can provide insight into trends in clinical trials and support clients with their cover requirements.
To find out more about insurance for clinical trials, speak to your Aon account manager or contact Matt James at [email protected].