Forthcoming webinars - information and registration.

Unmet clinical needs assessment for biomarker evaluation - a practical toolbox for Laboratory Medicine.

Speaker: Phillip Monaghan (UK)
Moderator: Christa Cobbaert (NL)
Date: 23rd April 2019 at 18:00 CET

Registration is open (enter the course to register). 

How to enter the course?

The translation of promising biomarkers to clinical application is a critical opportunity for laboratory medicine; to provide information that enables clinicians to make better decisions about the care of their patients. The realisation of this goal is itself critically dependent on the appropriate evaluation of novel biomarkers for use in the clinical setting.

Inherent to this concept is consideration of the unmet clinical need that a laboratory test is aiming to address.  However, as testing guides downstream clinical interventions to improve patient outcomes, the link between testing and outcomes is often indirect. As such, a full mapping of the clinical care pathway to define the purpose and role of the laboratory test and importantly, the clinical management decisions that the test will inform, thus enables the unmet clinical need to be addressed and furthermore complemented by the anticipated impact on patient outcomes.

The corollary from this approach is the early specification of analytical and clinical performance criteria to subsequently evaluation studies in a cyclical manner, keeping the clinical care pathway and outcomes as the key drivers in the process. In doing so, biomarker development can be aligned to address existing gaps in clinical care and mitigate research waste and inappropriate utilisation of laboratory tests where clinical benefit is uncertain or at worst potentially harmful.

There is a major opportunity here for laboratory professionals to play a key role in the development and implementation of clinical care pathways for new and existing laboratory tests. Stakeholder involvement; working together to overcome the conventional silos across disciplines is paramount to drive the adoption of innovative tests with robust implementation planning, so that test results are available and acted upon in an appropriate and timely manner, with a strong link to clinical intervention and outcomes. To realise the value of laboratory medicine in this context, the EFLM Working Group for Test Evaluation (WG-TE) has developed a ‘practical toolbox’ providing a Test Evaluation Framework and Interactive Unmet Clinical Needs Checklist (hosted on the EFLM eLearning platform) to assist laboratories and other key stakeholders in clinical translational research, to undertake clinical needs assessment and clinical care pathway development.



Speaker: Abdurrahman Coşkun
Moderator: Merve Sibel Gungoren

Date: 14th May at 18:00 CET

Registration is open (enter the course to register).

How to enter the course?

Internal quality control (QC) is the backbone of quality system in laboratory medicine, which serves to validate patients test results. However, it monitors the system intermittently, not continuously. Classical QC monitoring system depends on periods such as weeks, days, or predetermined time intervals and therefore detects some but not all analytical defects. In this situation, we have not much information about what is going on between these periods. To overcome this problem, we need a real-time monitoring system to detect the possible errors while the instruments are running.

Autoverification programs evaluate and release test results as soon as they receive data from the instruments. Therefore, when we detect errors using classical QC monitoring system, the test results of a large number of patients might have been reported to clinicians and/or patients already. This is a major risk for patients’ safety and when we detect errors, it wouldn’t be easy to re-analyse all reported patients’ samples. 

The devil is in the detail. We should monitor the system continuously using a suitable algorithm based on patients’ data. The aim of this webinar is to raise awareness for the necessity to monitor analytical instruments continuously while reporting test results.