Insurance and indemnity coverage for clinical trials of medicines in Kenya

Abstract

Background: Risk management is an important aspect in clinical trials due to the associated risk of injury to the study participants. There are both ethical and legal guidelines globally that are meant to ensure that there is compensation to study participants who are injured as a result of participation in clinical trials. Clinical trial insurance is one method of risk management that ensures that study participants are compensated for injury and study investigators are covered for liability that might arise in the course of the clinical trial. The Kenya Clinical Trial guidelines provide for the provision of indemnity cover and insurance during the conduct of a clinical trial. However, the guidelines do not provide a standard form of the clinical trial policy. This study was conducted to review the current clinical trial insurance arrangements and compensation mechanisms for clinical trial related injury in Kenya. Objectives: The overall objective of the study was to evaluate the insurance and indemnity arrangements for clinical trials in Kenya, and assess knowledge among various stakeholders on the policies related to compensation of clinical trial related injury in Kenya. Methodology: The study was conducted in two parts; a retrospective descriptive review of the insurance documents and informed consent forms attached to the clinical trial protocols submitted to Pharmacy and Poisons Board between 2011 and 2014 and a qualitative study involving in-depth interviews with key stakeholders involved in the ethical review and approval of clinical trials and an underwriter of clinical trial insurance. Quantitative data analysis was done using Statistical Package for Social Sciences (SPSS) and StataCorp. 2010. Stata Statistical Software: Release 10. College Station, TX: StataCorp LP. For qualitative data analysis, an inductive approach to analysis was used focusing on emergent themes arising from the key informant interviews. xv Results: Out of the 78 clinical trial applications reviewed 14(19.9%), 15 (19.2%), 24 (30.8%) and 25 (32.1%) involved Phase I, II, III and IV trials respectively. Sixty three (80.8%) of the clinical trials involved drugs registered in Kenya compared to 14 (17.9%) that involved investigational drugs. A review of the insurance documents showed that only eighteen (23.1%) of the clinical trial protocols reviewed had clinical trial insurance certificates attached with 28.2% of the protocols containing professional indemnity certificates for doctors. Eleven (61.1%) of the insurance certificates had both the “clinical trial insurance” and “product liability insurance” type of insurance indicated and thirteen (72.2%) of the insurance offered was of the no-fault type. Bivariate analysis showed that Phase I trials and trials involving investigational drugs were more likely to have clinical trial insurance.A review of the informed consent documents showed that fifty seven (73.1 %) of the protocols mentioned that compensation would be provided in case of trial related injury with medical care (85.2%) being the most common form of compensation provided. Majority of the interviewees (87.5%) indicated that there was insufficient knowledge on clinical trial insurance in Kenya while75% reported that medical care for injured participants was the most common form of compensation for clinical trial related injury that they were aware of. Conclusion: The proportion of clinical trial applications with clinical trial insurance that covers research participants was significantly low and some informed consent documents did not mention how compensation for research related injury will be provided. There is need for the development of clinical trial compensation guidelines and insurance requirements for clinical trials. There is also need to sensitize stakeholders involved in the conduct, ethical review and approval of clinical trials on insurance and compensation for research related injury.