Current Situation And Counter Measures Of Insurance In Clinical Trials

Objective To explore the current situation of insurances in clinicaltrials and the insurance clauses related to clinical trials in China; to improve theexisting problems about insurance in clinical trials, and to push the implementation ofinsurances included in clinical trials. Methods The current status of the domesticclinical trials insurance was analyzed through comparisons with other countries andanalysis of the typical events. On this basis, new drugs and medical instrumentsclinical trials in research collected from Clinical Trials Center from2010to2013were investigated, and insurance clauses of four insurance companies were analyzedand then compared. Insurance related problems existing in clinical trial and relevantcountermeasures were proposed. Results There are still some insurance relatedproblems in clinical trial: the insurance coverage is low; type of insurance is imperfect;most of the foreign sponsors who provide insurances for clinical trials did not provideinsurance instruction in Chinese; there is no authoritative body or regulation toidentify drug-related SAE; foreign sponsors usually purchase insurances from foreigninsurance companies which could not apply to medical status in China; the scope ofSAE compensation is not clear; there are no clear provisions referring to whether theSAEs above expected severity need to be reimbursed; whether the expenses producedby the avoiding of SAEs should be reimbursed is not mentioned; ethical review is notsufficient, not involving reviews on insurance contracts and insurance content，et al.Facing all the problems, clinical trial participants are required to enhance awarenessof buying insurance and to choose the right insurance in accordance with the specificcircumstances of clinical trials; also, Ethics Committees should deepen the review onthe content of insurance; in order to better protect the interests of participants includedin clinical trials, laws and regulations should be improved. Conclusion Nowadays,the coverage of insurance in Chinese clinical trial still falls behind in comparison withforeign countries, and insurance system in China also is not perfect. To optimizeinsurance situation in clinical trials calls for joint efforts from supervisiondepartments, Ethics Committee, clinical departments and insurance companies, and so on.