In 2000, there were 2,100 trials recorded around the world with this figure rising to nearly 500,000 in April 2024 as the discovery of new diseases continues to spearhead the increase and demand for clinical trial research. Discussing the evolution of the global clinical trials market, Rob Hannaford, senior life science underwriter at Markel, and Hannah Barone, director, life sciences at Markel Specialty, emphasised the critical role insurance plays in enabling this evolution.
Hannaford (pictured left) sees the growth trend continuing in the wake of global health emergencies such as COVID-19 which required strong collaboration between medical professionals, worldwide. “I see this growth continuing, with some experts suggesting this number getting closer to 1,000,000 in the next 10-15 years.
“Drivers for this further growth will include pushes for patient-centric approaches to treatment, including personalised medicine and the further rise of decentralised clinical trials. This allows for greater flexibility and convenience, which will ultimately increase patient enrollment and the number of clinical trials, worldwide.”
In the US, Barone (pictured right) said there is lots of competition to write clinical trial programs, but limited ability to handle the foreign trial placements. Given the complexity with foreign jurisdictions, she said, most life science brokers rely on a few carriers for the local policies. Also, more and more trials are being recruited in foreign countries rather than the US, so there will continue to be a growing need for service and capacity in foreign countries.
There’s a strong regulatory foundation underpinning what’s happening in the clinical trials market and that’s where insurance has its time to shine. Hannaford noted that from a regulatory perspective, the role of insurance and insurers is to provide fully compliant coverage, which adheres to the regulations in any one given territory.
Regulatory bodies such as the European Medicines Agency (EMA) require insurance under their clinical trials regulations, he said. This mandates that sponsors and investigators must have suitable insurance covering liabilities arising from the trial. “This insurance coverage is often the final hurdle that sponsors and research professionals need to evidence to the ethics committees to allow their research to begin.
“Failure to provide compliant coverage can halt the start of these trials, which can be expensive both financially and reputationally to the sponsors, while also delaying treatment to patients in need. Given that insurance is often the final hurdle to begin clinical trials, it’s important that service standards are optimised to not cause any regulatory delays, due to insurance for the client.”
The coverages required before a clinical trial can go ahead vary from country to country, Barone said, which is why having an insurance carrier that is familiar with these requirements helps sponsors execute their trial efficiently and effectively. For example, some countries will require different policy language or coverages and purchasing insurance will help the sponsor comply and then also protect them in the event of an injury during the trial.
Hannaford highlighted that an existing gap in clinical trials coverage is around travel insurance, as failure to have this coverage can often deter patients from travelling to participate in clinical research overseas. The limitations of current travel coverage for patients with existing conditions can make it unviable for them to travel for clinical research, he said - this results in reduced patient data and slower progress in rare diseases.
Failing to secure clinical trials insurance can mean not complying with the regulatory guidelines as insurance is often part of the framework of most countries, meaning the trial may not receive approval to begin. Delays due to failure to secure insurance can be financially and reputationally expensive, he said, as the costs of undertaking clinical research is very expensive and missing any deadlines can push back commercialization and impact future funding.
Barone noted that in addition to accident & health or trip transit cover, medical expense coverage sub-limits are also important for a sponsor to consider when purchasing insurance. The sub-limits can often vary in size and the sponsor and broker should discuss what limit is appropriate based on the protocol. Failing to secure clinical trial coverage could open the sponsor up to financial liabilities that may prevent them from achieving the milestones necessary to gain regulatory approval for commercial use.
Discussing where clinical trials coverage is likely to go next, Hannaford emphasised that the coverage is a service-driven industry. Being able to provide just in time coverage is vital to ensuring that clients have suitable coverage in place to meet regulatory deadlines, he said. With the advancements of technology, further optimisation of the value chain from an insurance perspective is the future of clinical trials insurance.
“With global clinical trials on the rise, it’s important that insurers continue to be creative to provide compliant solutions, worldwide,” he said.
Barone believes that there are several ways that clinical trials coverage will evolve. First, she said the process to get a quote and bind for clinical trials will need to evolve to be as streamlined and accurate as possible. With all the advancements in technology, people expect quick and accurate responses.
“I also think there will be a push to customize coverage for each insured. For example, ability to add or remove exclusions or coverage grants more frequently.” Lastly, she said, there are a handle of insurance carriers that can offer local insurance placement and collaboration is the key to developing the advantages of speed service and accuracy in this global marketplace.
