RTSM (Randomization and Trial Supply Management) for Early Phase Studies

Phase I and early Phase II studies generally have the aim of establishing the safety, tolerability and pharmacokinetics of one or more doses and formulations. Traditionally many of these studies have tended to be conducted at a single site so that the randomization, dosing, dispensing, blood sampling procedures and progression between successive cohorts could be tightly managed. Allowing competitive recruitment may be particularly important in patient studies in populations where it is difficult to recruit. RTSM (Randomization and Trial Supply Management) technology allows management of the recruitment to each cohort which would be difficult, if not impossible, to coordinate with many centers. Examples are given in this letter to show how RTSM technology can be used to manage randomization, cohort progression and dosing in multicentre early phase trials. Additionally, a sample survey of the incidence and types of early phase cohort studies performed by Perceptive Informatics was undertaken. The survey of our database showed that many early phase studies are conducted in multiple sites and countries with fairly low numbers of patients per site; this reflects the need for speed on the critical path for drug development.