Thanks for that ...... seemed like an obvious answer I guess ..... so also just looked it up as well . but now I bettwer undertand the significance particularly in the context of the quality of the date ahtat IMU have produced .
Clearly very very relevent to the 2 recent trials thay have announced over the last 30 days .
Also just watched that very recent video interview with Leslie Chan ...sounding extremely up beat and positive. These next 6 months or so may herald a "paradigm shift " to use Leslie Chans own words , not only in Oncology Treatment .....but how the general market views IMU More about IDMC's When to Engage an IDMCThe primary purposes of the IDMC are to assure that: the interests of patients entered on the trial are being well-served (i.e., that the risk-benefit ratio is appropriate) and the scientific integrity of the trial is maintained during the period of interim analysis. Virtually all clinical trials potentially pose some risk to patients under treatment. Given that sponsors have vested interests in trial results, it is generally agreed that IDMCs are needed for randomized studies, in particular those that involve multiple sites and endpoints such as survival or other critically important health outcomes. If there are particular concerns about risks because the treatment may involve toxicity, or there is a relative lack of experience with an agent making assessments somewhat unpredictable, then these issues need to be taken into consideration when contemplating whether or not an IDMC is needed.
The clearest reasons to establish an IDMC is to enhance the safety of trial participants where safety concerns may be unusually high. In this case, regular analysis of the interim data is critical. For any interim analyses outside the SAP, the trial sponsor should be fully blinded. For SAP related intermediate endpoints, the sponsor may or may not have access to binary (yes/no) outcomes of the analyses. The trial then should continue in accordance with the original design and SAP.
It is not just the agent and experience with the intervention that determine risks, certain populations are more fragile than others including children, pregnant women, or the elderly and extra measures of IDMC protection may be necessary regardless of the perceived risks of the drug under study.
Go to:The Members of the IDMCThe IDMC is typically comprised of 3–5 individuals with extensive clinical experience both in the disease under study, in the management of large complex clinical trials that represent different expertise and points of view (e.g. patient advocate). Each trial has an IDMC appointed by the trial sponsor and each trial should have a distinct IDMC. Larger committees have been suggested by some but the necessity for in depth discussions and the practicalities of ensuring availability suggest that a small group of committed individuals is best. Two clearly designated positions are typically present, these positions being the Chair and the Statistician. The Chair is expected to lead the IDMC in deliberations (especially in “closed sessions”
, sign the official minutes (after review by all IDMC members), and be responsible for communications to the sponsor. He/She should have considerable experience both in serving on IDMCs and in the disease under investigation. Given the fact that many adverse events in cancer patients are not due to drugs, but rather due to the underlying disease, and that adverse events are typically reviewed in the interim without causal attributions (to drug or disease), experienced clinicians familiar with the disease under study are critical for appropriate decision making. A statistician expert in the disease under study might or might not be available but having an expert with both statistical expertise and disease expertise is clearly optimal. Individuals without experience in the disease under study can be a clear liability during deliberations.
Expert statistical input is an absolute requirement for optimal IDMC function and it is best if that statistician has experience in the nuances of the disease being addressed. In all instances, for large registrational-type trials, some prior IDMC experience should be a requirement for all IDMC members given the often complex decision making that can occur during the interim data analysis.
(20min delay)