Independent Data Monitoring Committee (DMC)
GHD
ADVERSE EVENTS, RECRUITMENT, GHD
Data analyses will be supplied in confidence to an independent DMC, which will be asked to give advice on whether the accumulated data from the trial, together with the results from other relevant research, justifies the continuing recruitment of further participants. The DMC includes members who are independent of the trial, the trial investigators, their employing organisations, funders, and sponsors. The DMC have no competing interests. The DMC will operate in accordance with a trial specific charter based upon the template created by the Damocles Group. The role of the DMC is to safeguard the interests of trial participants; assess the safety and efficacy of the interventions during the trial; ensure the trial collects the necessary information to address the trial question; and monitor the overall conduct of the clinical trial. The DMC will receive and review the progress, the accruing data and details of all serious adverse events of this trial and provide advice on the conduct of the trial to the trial steering committee (TSC). The DMC is composed of a chair based on previous experience of serving on DMCs and chairing meetings, an expert DMC statistician and two clinicians with experience in GHD and clinical trials methodology. The DMC will meet at least annually as agreed by the committee and documented in the charter, unless there is a specific reason (e.g. safety phase) to amend the schedule.Additional meetings may be called if recruitment is much faster than anticipated and the DMC may, at their discretion, request to meet more frequently or continue to meet following completion of recruitment. An emergency meeting may also be convened if a safety issue is identified. The DMC will report directly to the TSC, who will convey the findings of the DMC to the funder, sponsor and MHRA as relevant. The DMC may consider recommending the discontinuation of the trial if the recruitment rate or data quality are unacceptable or if any issues are identified which may compromise participant safety. The trial will stop early if the interim analyses showed differences between treatments that were deemed to be convincing to the clinical community.