Noncompliance and late graft loss: Implications for long-term clinical studies

Long-term studies will be necessary to determine cost-effectiveness of new immunosuppressive agents. Yet most long-term studies do not consider the role of noncompliance. In some analyses, noncompliance has been shown to be associated with decreased graft survival. Others report an association between noncompliance and an increased rate of acute rejection episodes. Importantly, an acute rejection episode is a major risk factor for development of chronic rejection and long-term graft loss. Thus, noncompliance can have a major impact on the outcome of clinical trials. This should be factored into trial design.