Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘Figure 1. Typical timeline for a multicenter trial with the primary outcome assessed at 6 weeks.The activities will vary with each individual trial.Up to 2 yearsprior to the startTask of funding Year 1 Year 2 Year 3Protocol developmentand funding secured Submission for regulatoryapproval (all countries) Preparation of trial materials Organization of randomization Submission for ethics approval Establishment of trial centers Investigator meetings Interim trial results reviewed bydata and safety monitoring board Recruitment Follow-up at 6 weeks Data collection Data cleaning Designing and performingdata analysis Dissemination andprimary publication |-2|0|1Time relative to the start of funding (years)|2• site monitoring visits• organizing local and international meetings for investigators and trialcommittees such as the steering, events adjudication, and data andsafety monitoring board committeesCoordinating teams will also need to tag each item of data so that the centergenerating that item can be identified, and edit-queries regarding missing orincorrect data will need to be directed to the appropriate center. Throughout thetrial, the coordinating team will maintain communications with all relevant parties(eg, from sites to academic institutions, from ethics and safety committees tosponsors), all of whom are likely to be independent of each other.Finally, the coordinating team may assist with the dissemination of the resultsthrough further meetings or publications and presentations. Established andexperienced coordinating teams are particularly successful because they arefamiliar with the many national ethics bodies and their requirements, and will beable to recruit centers that have already demonstrated an ability to meetrecruitment targets and send data with minimal editing queries.157