International Clinical Trials: Look Before You Leap

Logistical problems and financial pressures prompt many medical technology and life sciences companies to sponsor human clinical trials outside the borders of the United States. As important as the decisions made regarding in what countries to conduct clinical trials, which Clinical Research Organization (CRO) to use and the development of protocols, is the need to learn the local requirements and comply with them. Often one such requirement is the need to provide evidence of acceptable clinical trial insurance protection.

For example, The European Union Clinical Trials Directive (EUCTD) published in 2001 set out to simplify and harmonize the administration of clinical trials throughout the European Union. However, it has not resulted in a streamlined and simple clinical trials insurance structure. Insurance requirements continue to vary among countries and failing to incorporate insurance requirements into the clinical trial planning process can cause delays and cancellation of trials.

One Size Does Not Fit All

In addition, once a policy is in place for a clinical trial taking place in a country which specifies insurance requirements, the United States, it is likely that it cannot be amended or extended to include other trials. In many situations, one policy will not satisfy local or ethics committee requirements. Also, coverage requirements are not uniform among countries. Further, ethics committees are known to have different interpretations of what constitutes compliance with local regulatory requirements. The following illustrates this last point. Several years ago, a company successfully completed Phase I and II trials of a combination device for people suffering from severe allergies due to spring season pollen. When the company was ready to launch the Phase III study in four European countries, two of the four ethical commissions would not allow the trial to start, because the insurance certificates failed to meet their requirements. Since there is only one spring pollen period per year, the Phase III trial in these two countries was delayed by one year. Another issue related to clinical trials conducted outside the United States is coverage jurisdiction. Insurance protection that meets the requirements of a specific country and local ethics committee may only cover claims brought in the country where the clinical trials were administered and fail to provide coverage for claims made in other countries.

When Time Is Not On Your Side

In companies conducting clinical trials often there is a lack of timely communications between Regulatory Affairs/Quality Assurance and Finance on matters pertaining to clinical trials insurance. Typically, Finance learns of the need for evidence of acceptable insurance within a few days or week, prior to submitting protocols to ethical commissions. When this happens, procuring the necessary insurance coverage can be a race against time.

Coordinating national and international insurance placements is not a task for general insurance brokers. Placing coverage using multiple insurance policies for individual trials conducted in several countries parallels the complexity of complying with the regulatory requirements in those countries. To this end, it is important to work with specialists who focus on the unique business and insurance/risk management needs of medical technology and life sciences companies conducting world-wide clinical trials.

Frederic Nouaille is Director of Biomedic-Insure. He can be reached at frederic.nouaille@biomedic-insure.com.