Clinical Trial Insurance Issues

January 12 - Conducting clinical trials on a group of people before a drug can reach the market is an integral part of its development process. As the United States looks beyond its borders to countries such as South Africa in order to find a bigger pool of participants, a number of issues come to the forefront, including that of insurance for patients who may become injured in these clinical trials.

It has been shown that 43% of clinical trials were performed outside of the United States last year, and estimates put that figure rising to around 65% within the next three years.

Insurance is an important part of any trial, but the difficulty with bureaucracy and regulation in many countries makes it hard to ensure patients' safety until the very end - and as a result, the scope of international clinical trials is being limited in many regions.

Countries such as South Africa as well as certain parts of Asia, Eastern Europe and Latin America, have adopted an international standards practice known as the Good Clinical Practice, put forward by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

By adopting these standards, either as legislation or as a guideline, South Africa and other countries are able to improve patients' safety, which could ultimately lead to regulations that are more consistent in the long run.

An insurance company considers many factors when deciding whether to insure a clinical trial and its participants. These include internal and external factors, such as medical facilities, the make up of the patient group, regulations and legislation, and a well designed protocol.