Do clinical trials work?
The gauze is starting to be removed from the world of clinical trials. As transparency increases, so too will the likelihood of legal liability for drug makers and other trial sponsors. A recent article in the New York Times demonstrates that this type of news has become mainstream. First, the news. Then the implications for risk management.
The NY Times story and others like it in the popular press give rise to greater knowledge that the data from clinical trials is imperfect inherently. For example, trial populations are seldom representative of those with the disease or condition. Participants are usually much younger than the average sufferer. It is just harder to recruit older participants who are less likely to desire participation in a speculative trial when their remaining life from a successful outcome is not as long as for younger persons. Further, trials are often too small and don’t have enough post-approval follow-up. The recent announcement that Avastin actually did not improve outcomes for brain cancer after having been approved for large-scale cancer usage is just an example of this phenomena.
And that leads to risk management and insurance implications. The world of clinical trials is becoming more transparent. As reported in this blog earlier, many drug companies are now posting their failures as well as their clinical successes. All of this, however, and the added public discussion demonstrated by mainstream media coverage does two things. It makes unhappy trial participants more aware of the inherent weaknesses of the process that they have undergone and hence more likely to bring a lawsuit for any perceived unfavorable outcomes. Just as importantly, it makes more plaintiff’s attorneys aware of the potential goldmine of litigation, despite the most well-designed trial and consent form. Add that to a changing state of art and the likelihood of successful lawsuits is increasing. Sponsors need to plan accordingly.
About the Author
Phil Edmundson is the Chairman and CEO of William Gallagher Associates, insurance brokers and consultants for businesses with over 30 years in the insurance industry. He manages strategy, talent acquisition and development, and management / acquisitions at WGA.