Clinical Trials

❘❙❚■ Chapter 16 | Multicenter TrialsFinancial considerationsMulticenter trials require more resources than single-center trials. Budgets formulticenter trials are more complex and usually require that several years offunding are secured from the start of the trial. Rarely can a multicenter trial beperformed in under 1 year (although for the same protocol design, a multicentertrial will still be faster than a single-center trial). Also, start-up costs are oftenconsiderable, with compilation of a protocol, securing a center and personnel tomanage the trial, designing and printing case report forms, invitation ofresearchers, and multiple ethics submissions required. Events such as investigatormeetings, site authorization, and start-up visits will also need to be budgeted for.Often, large trials now have a ‘roll-in’ phase for the first few patients from eachcenter before the trial gets into full swing. At the end of the roll-in phase, each siteis visited to verify that all is going according to the protocol. At this stage, protocoldeviations will trigger protocol amendments. In a multicenter trial, amendmentsare extremely troublesome as each ethics review board or IRB has to be notifiedof the amendment and all sites have to be sent revised paperwork.The amount of data that a multicenter trial is to collect has an important bearingon funding. Large amounts of data are only necessary if they are to be used forregulatory submissions. Collecting, entering, and cleaning data is expensive, so itis important only to collect data that will be used in the final analysis.For every trial that completes successfully, a number fail due to recruitmentproblems. If a trial is falling behind recruitment targets then it is essential to seethis early on so that remedial measures can be taken such as adding centers.Publication policyIn a multicenter trial there is usually a manuscript writing committee or group.This group helps to facilitate a standardized approach to all the statisticalanalyses, ensures that conclusions from the results are appropriate, recommendswhich investigators should be lead authors on publications, and deals with otherauthorship issues. The key publications from multicenter studies will usuallyacknowledge all participating investigators and may be authored simplyas ‘the “X” trial investigators’.ConclusionIn recent years an increasing number of multicenter trials have been performed inmedical research. Such trials bring with them a host of practical problems in termsof their design, conduct, and analysis because of their size, organizationalcomplexity, and the large number of investigators involved. In this chapter we162