Many clinical trials incorporate evaluation of endpoints for either efficacy or safety, by independent adjudication committees. Committees evaluating Efficacy Endpoints are termed Clinical Event Committees (CEC), whereas those concerned with Safety are known as Data Safety Monitoring Boards. In both cases Committees are comprised of Physicians with expertise in the relevant therapeutic area or clinical specialty. Committee members will review all relevant data, to provide an independent determination of trial endpoints or events. In most cases the Committee will be blinded to treatment received.
Historical Perspective
Historically Adjudication Committees have been based in the academic sector, and have operated within a paper-based environment. Such an environment generally relies on evaluation of paper CRFs, summary tables and data listings. Other relevant data, such as ECG tracings, laboratory reports, videotapes, or films must be reviewed manually using cumbersome dossiers. Dossiers are traditionally reviewed in a group setting with decisions achieved by consensus. The complexity of these dossiers and the difficulty in achieving consensus does not easily allow simultaneous project tracking or provide an optimal audit environment for sponsors. In particular it can be difficult to keep track of additional data required to make decisions. Despite high level physician expertise, the conduct of the committee can be affected by difficulty in accessing critical data within the subject dossier.
The Unmet Need
The disconnect between expertise of Physician reviewers and the mode of data review creates an unmet need in the field of Clinical Trial Adjudication.
Advantages of the ICON Medical Imaging Adjudication Solution:
- Experience of our Chief Medical Officer and involvement of our panel of academic Physicians
- Electronic organization of data coupled to eCRF
- 24/7 secure online access for independent remote access Adjudication
- Programmatic identification of Adjudicator discordance and programmatic initiation of consensus adjudication
- Our superior MIRA™ technology allows:
- Reliable, secure audit trails
- Ability to track progress of Adjudication and meet your timelines
- Direct interface with various EDC systems as well as programmed SAS input
- 21 CFR Part 11 compliance
Superior Technology
The ICON Medical Imaging Adjudication Solution is based upon an on-line data and image viewing, electronic CRF (eCRF) completion and project tracking system called MIRA™. The use of MIRA™ allows for a paperless and real-time Adjudication solution. The proprietary MIRA™ system enables clinical data and related images to be posted and viewed by committee members on-line in an electronic and fully 21 CFR Part 11 compliant manner. Data can be “cleaned” prior to posting, which reduces error.
ICON Medical Imaging builds electronic case report forms (eCRF) that link to this and control the presentation of data. For example, each Adjudicator needs to go through each patient on a timepoint by time point basis sequentially to review events and assess if they are real or not. The eCRF would launch the patient data that may include; the images, lab values, the pdf of an AE report, and the ECG; into the viewer once the reader has logged in. This data is blinded and identified by a randomized code that has been pre-assigned. The adjudicator then completes a logically controlled eCRF forcing him or her down a decision tree and ensuring all questions are answered. At the end the adjudicator confirms the event and electronically signs. Every step is recorded and is auditable. MIRA™ tracks everything, including what data the Adjudicator sees. When this timepoint is "locked", the system closes the information on the screen and brings up all data in the next timepoint. If extra data is required the case remains held in a queue. This is simple, fast, and easy for the Adjudicator.
Summary
ICON Medical Imaging’s superior technology coupled with the prior clinical, regulatory and adjudication experience of our senior staff as well as access to our expert panel of physicians is unmatched in the marketplace.
To review a sample on how ICON Medical Imaging's Adjudication Solution works, please click here.