A CLINICAL APPROACH TO INSURANCE
MARSH - Two years ago clinical trials captured the UK media spotlight when six people participated in a clinical trial that went horribly wrong, resulting in serious endangerment to their health. But what exactly is a clinical trial?
There are many definitions of clinical trials, but they are generally considered to be biomedical or health-related research studies with human beings that follow a pre-defined protocol. These are divided into two main groups, interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
What happens during a clinical trial? The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Insurance has become increasingly important in clinical trials in recent times. Cases against drug companies and medical-device makers are now being launched with an increased frequency. For example, this has prompted a virtual cessation in contraceptive research. One US based manufacturer withdrew a new product, a long-term reversible contraceptive product, after five years of litigation and over $50 million in legal costs.
More stringent legislation has also increased the complexities surrounding clinical trials. In Europe for example, clinical trials are governed by the EC directive 2001/20/EC. The directive refers only to Investigational Medicinal Products. It also states that a clinical trial may be undertaken only if provision has been made for insurance or indemnity to cover the liability of the sponsor. The purpose of the directive is to:
Protect trial subjects (patients and healthy volunteers)
Improve quality of clinical research
Produce credible data, introduce inspection on adherence to Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
Reduce duplication of paperwork by harmonising requirements and procedures
Many countries have implemented local rules, with varying degrees of severity. For example:
Italy has only made local insurance compulsory
Switzerland will only accept insurance where the named Insured is a Swiss legal entity
Poland requires from EUR 500,000 (up to 10 Patients) to EUR 5,000,000 (100+ patients)
Belgium requires unlimited strict liability.
However, one of the biggest risks in the insurance process for entities involved in clinical trials is not a claim. Its DELAY. Delay can cost more than claims due to: loss of patients, cost of staff/the research company/ contractors, and ultimately delaying the product reaching the market place. Delay can be caused by not having the correct coverage or evidence of coverage to obtain EC approval.
To tackle the more complex risks and insurance requirements relating to clinical trials, Marsh developed Centres of Excellence for clinical trials with local experts around the world working via a coordinated network the largest team is located here in Norwich. The team consists of five members and provides Marsh and our clients with a centralised knowledge and placement centre which is able to handle risks or to assist a client anywhere around the world.
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