Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘Facilitating collaborationMulticenter trials clearly involve more personnel than single-center studies,including a range of investigators and their research teams. The coordinating centermust maintain records for all of these individuals, including their resumés andsignatures. Such information is needed in order to conduct an audit at each stage ofa trial to ensure that every piece of data can be linked to a specific researcher.If there are any queries, the coordinating center will communicate with the locallead investigator who has responsibility for the actions of a center and itspersonnel. These local lead investigators will be identified in reports andacknowledged in publications of the primary results from the study. Coordinatingcenters should also confirm that ‘black-listed’ researchers do not participate intheir studies. The US Food and Drug Administration (FDA) and other nationalagencies make available lists of clinicians who are suspended from performingcertain types of research.Meeting recruitment targets and maintaining moralein multicenter trialsIn large trials, motivating centers to meet or maintain recruitment targets isessential because, once a few centers slow down, others might follow suit in a‘domino effect’. This task is made considerably harder by the large number ofindividuals involved in the trial. In a clinical setting, performing a randomized trialrequires time and enthusiasm from already over-committed clinicians and nurses.Therefore, it is essential to market a trial in an imaginative (but ethical) way.Studies performed in key disease areas where there is a lot to gain by improvingpatients’ quality of life tend to be successful. Such studies have greater impact andencourage the participation of centers and investigators.The coordinating team can also boost morale with newsletters and meetings.Once the study is underway, an eye-catching trial newsletter can become anexcellent source of study-specific information and can provide a source of answersto frequently asked questions. Anything that will raise the trial’s profile shouldbe considered, such as posters, pens, and promotional stands at appropriateconferences. If recruitment targets are being met, then it is important to keep therecruiting centers informed and to thank them. If targets are not being met,league tables of how many patients each center has recruited can be presented toact as a stimulus to slower recruiting centers. A trial-specific web site is alsohelpful, allowing investigators from different sites to communicate and raiseprotocol queries more effectively.159