What is Clinical Trial Liability Insurance and what information do insurers need to know in order to provide an accurate quote?
The Medicines for Human Use (Clinical Trials) Regulations 2004 (and subsequent amendments) state that a clinical trial may be undertaken only if provision has been made for “insurance or indemnity” to cover the liability of the researchers in relation to the clinical trial. Therefore the relevant approving bodies will insist on Clinical Trial Insurance cover before approval is given, the purpose being to insure the public/products liability as well as no fault compensation.
Specialist clinical trial liability insurance 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.
The purpose of a clinical trial is to establish whether or not a medical treatment, device or strategy is both effective and safe for use on humans. The clinical research should follow strict scientific standards in order to protect the trial participants as well as deliver reliable data. Starting out in the lab, then potentially moving on to testing on animals, ideas that show promise eventually make it to human clinical trials, where small groups will initially take part in order to measure the effects of the new medical treatment, device or strategy. Clinical trials are a vital part of any medical research programme. Without completing the necessary and proper clinical trials the appropriate approvals will not be granted.
All clinical trials of medicines and studies on medical devices* need to be approved first by a peer review and then the National Research Ethics Committee. The role of the committee is to ensure the clinical trial is well planned and meets all the necessary requirements, one of which being that the researchers have arranged for compensation to be paid if anything should go wrong. Any clinical trial in the UK also has to be authorised by an organisation called the Medicines and Healthcare products Regulatory Agency (MHRA).
(*Class I medical devices are self-certifying from a CE point of view and are not subject to significant regulatory oversight. Also, many devices are not required to go through trial, often being “substantially equivalent” to other devices in the market that have already been approved)
When Things Go Wrong
Although claims are generally infrequent, when things do go wrong, the impact to human health can be great. A well reported case back in 2006 highlights the risks inherent in performing human clinical trials. The case of the ‘Elephant Men‘ hit the national press when eight healthy young men took part in a clinical trial of an experimental leukaemia drug known as TGN1412. Having been successfully tested on monkeys, what should have been a routine clinical trial soon escalated into one of the most infamous medical emergencies in recent British history. A BBC2 documentary covers the story; chilling stuff indeed.
There are unfortunately numerous other examples of clinical trials not going quite as expected.
Although not technically a clinical trial in the modern sense, the Thalidomide disaster in the 1950’s was the trigger for the establishment of the more rigorous clinical trials that we see today. Following rudimentary animal testing, the drug, a mild sleeping pill, appeared to be relatively harmless with no apparent overdose limit. Animal testing did not include tests looking at the effects during pregnancy. As well as promoting sleep, Thalidomide reduced morning sickness, becoming popular with pregnant women! The link with birth defects was made in 1961. It’s estimated that over 10,000 children were effected. Following a long criminal trial, those responsible for producing and licensing the drug were forced to financially support the victims.
From Thalidomide to more recent stem cell and gene therapy trials, the risks are ever present and the potential for huge damage to human health is obvious. Over time, knowledge, processes and controls improve and Clinical Trial claims continue to be rare, but should the worst happen, that cover has to be there.
Clinical Trial Insurance
All of the approving bodies will insist on clinical trial liability insurance cover being in place before the trial is given the green light. If cover is not in place early it often causes further delay and panic, as insurance is often the last thing on the mind of research scientists! The claims exposure for clinical trials is generally not the biggest insurance risk as claims are rare. It is the regulatory hurdles faced by initiating a human clinical trial. The trial won’t start unless the required coverage is in place.
A specialist policy will offer protection in two ways:
- Negligent Harm: 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 (no-fault): The policy would pay compensation inline with the ABPI guidelines to participants who have suffered harm. There should be a causal link to injury and study participation but the “who, what, when and why” of it is put to one side for the benefit of the injured party.
For guidance on Clinical Trial compensation, the Association of the British Pharmaceutical Industry (ABPI) has published a supporting document outlining the distinction between Phase I clinical trial compensation and Phase II,III and IV clinical trial compensation. Many countries follow the ABPI guidelines but not every county does, such as the US where it is a straight legal liability. The guidelines are in place for ethical reasons as people who are seriously ill can have little time to fight their cause in the courts etc. but “No fault” is not a blank cheque – there has to be a causal link between taking part in the study and the injury.
The insurance industry routinely provides Clinical Trial cover and often gives an either or approach (legal liability or “no fault”). Not all studies will have a no fault requirement. The value of damages is assessed the same way as legal liability and, in the case of a dispute, an arbitrator of sufficient experience and expertise will be appointed to determine damages, once again, according to the normal law.
What do Insurers Need to Know?
Below is the information that insurers are likely to need in order to provide a quotation for clinical trial insurance. Detailed information may not be required in the early stages, such as prior to submitting the trial to an ethics committee. Insurers are able to give an indication based on a draft proposal with an estimate of study numbers.
- The protocol and consent document including a note about the reason the study is taking place
- The limit requirement
- Whether there will be any other additional parties noted – it is quite common for entities such as the UCSD to want to be noted. They are also likely to want some kind of certificate, so full name and address etc. makes this quicker
- The local of the trial and the number of people involved
- The length of the trial