Tips for preparing for an IDMC
Written by Anu Matthew
What is an IDMC?
An Independent Data Monitoring Committee (IDMC) is a group of experts contracted to review data during a clinical trial. The members are individuals with ‘extensive clinical experience’ (Sartor et al, 2015) in that area of research, and they are independent of the Sponsor conducting the trial. Normally there would be medical and statistical representation but there can be other experts depending on the requirements of the study and the remit of the group is described in the IDMC Charter.
What does the IDMC do?
The IDMC is usually invited by the clinical trial Sponsor at pre-specified times during the clinical trial, to identify any safety concerns for the study participants or to analyse efficacy endpoints, or both. They then make recommendations to the Sponsor. These recommendations tend to be defined into 3 options, which are outlined in the IDMC Charter: stop the study, continue as planned or continue with some modifications (Sartor et al, 2015). It is important that the experts are fully independent because they are able to perform evaluations on the data that the study team would be forbidden to perform. This includes reviewing individual unblinded data to assess safety concerns, and analysing aggregated data to determine if efficacy endpoints have already been achieved. This is how the IDMC decides their recommendation. If the study team were to perform these evaluations this would jeopardize the integrity of a blinded study and interfere with the planned statistical analyses.
Why is it important to prepare?
As one potential outcome is for the study to completely stop the stakes are high and it is very important to provide the IDMC members with an accurate dataset for review so that they can make the correct recommendation. This means any inconsistencies in the data should have been queried and resolved where possible, and the IDMC are provided with as high-quality dataset as possible within an ongoing study. They need to be provided with sufficient detail on the study to orientate them around the data they will be reviewing, and any specific details on the data that may be confusing or where they may have questions.
How does the IDMC meeting run?
The IDMC meeting generally runs online and consists of an open session and a closed session. The meeting itself follows a period of review where the IDMC members can assess the data offline. To facilitate this the unblinded data needs to be provided to them ahead of the call in a secure location where it cannot be accessed by the blinded study team.
In the open session, an overview of the study and the data is presented by the Global Study Team to IDMC members. This gives the study team a chance to explain any inconsistencies in the data and provides the IDMC with an opportunity to ask any questions.
The closed session is where the members of the IDMC committee then convene and discuss the data presented and then come to a decision on how to proceed.
What is the role of the Medical Scientist or Study Physician?
As a Medical Scientist or Study Physician on a clinical trial, you might be asked to present data in the IDMC open session. This is a very important role as the IDMC may ask questions and expect the presenter to have all the answers.
How can a Medical Scientist or Study Physician prepare for an IDMC meeting?
- Know the data you will be presenting:
- Your slides should cover the top level, such as the number enrolled or randomized so far, but you may be asked for specifics such as the most frequent criteria noticed for screen failures.
- If there are any particular issues with the trial or the data, make sure you fully understand these; if needed discuss these with the relevant team members so that you feel confident when you present them on the day.
- Query for any inconsistencies and try to resolve as many as possible before the data are sent. The IDMC members understand that this is an ongoing study, but you will have some time from the Data Cut Off (DCO) until the data are delivered to try to resolve as many queries as you can so make good use of this time.
- Make a list of all the possible questions you can think of and have answers ready for them (e.g. most prevalent adverse events [AE], toxicity management of key AEs etc).
- Make a summary of the patient journey for patients who might pique their interest (e.g. a patient who died or a patient who had a grade 4 AE). These can be kept as back-up slides and used if any questions arise, or they could be presented to give a flavour of the safety profile.
- Use a team approach: Have an open conversation line between the presenter and someone else from the study team who is in the meeting. This other person can have all the relevant documents and systems open in the background to look something up during the call when needed. This person can support the presenter by providing quick responses in the “chat” so the team can provide the IDMC with the information they are looking for when they have questions.
Use of an IDMC is an important tool to protect patient safety in a large clinical trial as it can lead to additional monitoring and safety measures or stop the study completely if needed. It can also be really helpful for the Sponsor to have an independent perspective on the data to make decisions without jeopardizing their planned analysis.
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