Risk Mitigation and Due Diligence in Overcoming Lost to Follow-up [LTFU] Subjects in a Clinical Trial
The term ‘lost to follow-up’ describes a patient who has prematurely withdrawn from a clinical trial for whatever reason. But the clinical trial impact of their decision may result in incomplete study data, which can bias the outcome of the trial and the investigational medicine, and affect the statistical power of the study. Low rates of retention and high rates of patients lost to follow-up causes many ‘side-effects’, including a longer clinical research trial period that results in greater monetary expenditure as well as additional resources dedicated to recruitment efforts. Bernard Hall of L2FU (a subsidiary of MediciGlobal) recommends that for successful management of clinical trials one should set out with an LTFU process in mind from the start.