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The latest clinical trial that clearly went wrong, and had a catastrophic result for participants, took place in early 2016 in France. A drug test concerning pain relief, it resulted in one fatality and five hospital admissions with severe adverse effects - some of which led to long-term disability.1 It was a stark reminder that the risks associated with clinical trials should not be underestimated.
Last year’s incident occurred during Phase I of the pharmaceutical company's trials, much like a clinical trial in 2006 in which six participants in London suffered serious injuries following a dose of antibodies that caused their vital organs to fail within hours.
At the end of 2016, a new law regulating clinical trials was adopted in Germany. The Fourth Act on Pharmaceutical Regulations and Other Provisions, which went into effect on December 24, 2016, implements changes required by Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. The regulation governs EU state responsibilities and procedures for approving clinical trials while retaining previous regulations on clinical trials insurance.
Underwriting clinical trials insurance should begin with understanding the trial protocol and informed consent forms. In Europe underwriters also need to consider the position of the ethics committee. A good risk survey can help underwriters structure the most important information appropriately. Basic information includes the length and phase of the study, the number of participants and their states of health. Furthermore, the expertise of the parties involved needs to be reviewed critically with a view to managing potential complications.
For a drug to undergo regulatory approval, three phases of clinical trials are required. Phase I can have up to 80 participants and focuses on compatibility and safety of the drug. During Phase II, which can involve up to 300 people, participants take the appropriate drug dosage and the overall treatment concept is examined. Once Phase I and II are completed, the company can market the treatment and compile evidence of its efficacy during Phase III. Any additional studies carried out when the treatment is ready for the market are done for marketing purposes.
The most significant problems, such as incompatibility or serious adverse effects, generally show up during Phase I. This is when the potential loss is generally highest. Therefore, the parameters within which such a study can be insured should be examined closely, especially with regard to this part of the trials. Exposure decreases during Phase II and III; consequently, historical data also show fewer sizeable losses. However, the number of participants during Phase III trials needs to be monitored closely as higher numbers may also increase the probability of a loss.
We would be happy to help you underwrite clinical studies with our underwriting expertise and reinsurance capacity.
