“Tremendous scrutiny” of trials affects insurance; MD

26-Oct-2009 - Last updated on 26-Oct-2009 at 10:46 GMT

Globalisation and “heightened awareness and scrutiny of clinical trials” in the wake of the Northwick Park, UK incident, where some patients suffered multiple organ failure, have had a significant impact on study insurance, according to a MD.

Clinical trial insurance is required before authorities will give permission for a study to begin and as pharma and contract research organisations (CRO) have moved into new territories an understanding of local regulations has been required.

James Walters, managing director of Aon’s life science practice, explained to Outsourcing-Pharma that globalisation has had a significant impact on clinical trial insurance, which the company has been providing for decades.

The situation differs from country to country and creates a problem for pharma. Edwin Albers, director at Aon life sciences, explained that in some countries companies need to buy local insurance whereas in others global coverage can be used.

This is a problem facing big pharma, smaller businesses and CROs, all of which Aon helps with clinical trial insurance, according to Walters. He added that Aon operates in 120 countries, and can reach into others, which Walters believes is needed to understand global clinical trials.

Using this network Aon collects information about the requirements in different countries and this data has now been published on a map. It is the second year Aon has published a map and Albers expects further updates will be released in the future.

Impact of Northwick Park

Walters explained that the event at Northwick Park, London, UK has also had a significant impact on clinical trial insurance and led to increased awareness and scrutiny of studies in humans.

Following the incident the Medicines and Healthcare products Regulatory Agency (MHRA) has adapted its operations and now wants to see and review insurance policies. Furthermore, Walters believes the impact of Northwick Park extends beyond the UK and has affected other countries.

Looking ahead Walters said that he expects there will “continue to be tremendous scrutiny of clinical trials”, adding that Aon’s job “won’t get any easier”.