What you need to know to serve on them,
report on them or receive reports from them.
An Independent Data Monitoring Committee (IDMC) is a group of independent experts external to a study assessing the progress and accumulating safety and efficacy data of a clinical study during its course. The committee assesses the risk-benefit balance of the study and makes recommendations concerning the trial’s continuation, modification and/or publication . To date there are not enough qualified experts to sit on these committees and most of the time the roles and responsibilities are poorly understood by those conducting clinical trials. This workshop aims to train clinicians and other clinical trial specialists involved in cancer studies on how to interact with and, ultimately, become a member of independent data monitoring committees. The workshop will provide insights into the functioning, roles and responsibilities of IDMC through interactive discussions and worked real life examples; preparing the next generation of investigators and methodologists for cancer clinical trials.
Friday 26 January 2018
10:00 – 11:35
- Welcome and course introduction
- What aspects of trial data need monitoring during different stages of the trial life cycle?
- What do the regulations say?
- What is a DMC and how does its role relate to other trial oversight groups?
- Why might a DMC need to be independent?
11:35 – 12:55
- Which trials need an DMC / IDMC? (interactive group work)
- What is reported to an I/DMC?
12:55 – 13:40
13:40 – 15:05
- Issues when reviewing ongoing trial outcome data
- Introduction to stopping rules
- Acting on IDMC recommendations
15:05 – 16:30
- You are the I/DMC reviewing an ongoing trial (interactive group work)
- Who should sit on an I/DMC? (interactive group work)
- Key points
The EORTC – ICTM – UCL Interactive course on Independent Data Monitoring Committees (IDMC), Brussels, Belgium, 26/01/2018-26/01/2018 has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME®) with 5 European CME credits (ECMEC®s). Each medical specialist should claim only those hours of credit that he/she actually spent in the educational activity.
Through an agreement between the Union Européenne des Médecins Spécialistes and the American Medical Association, physicians may convert EACCME® credits to an equivalent number of AMA PRA Category 1 CreditsTM. Information on the process to convert EACCME® credit to AMA credit can be found at www.ama-assn.org/education/earn-credit-participation-international-activities.
Live educational activities, occurring outside of Canada, recognised by the UEMS-EACCME® for ECMEC®s are deemed to be Accredited Group Learning Activities (Section 1) as defined by the Maintenance of Certification Program of the Royal College of Physicians and Surgeons of Canada.
Online registration opens on 27 November 2017 and closes on 19 January 2018*
* 10.00 AM Central European Time (CET)
83 Avenue Emmanuel Mounier