Tuberculosis trials are cumbersome, long and expensive. Although this is due, in part, to the slow growth of the organism it is widely believed that biomarkers and surrogate markers could allow clinical trials to be completed with fewer patients, lower costs and more rapidly. The availability of new diagnostics methods is starting to change the way in which we monitor patients in tuberculosis clinical trials. This includes better culture techniques such as MGIT, molecular diagnostics such as Xpert, serial markers of bacterial load and viability such as the TB MBLA and host derived markers that might indicate cure. Considerable research is required to understand how such tools may be implemented in the clinical trials space and how regulators might view trials that use such techniques.
Educational aims
Overall, the aim is to enhance participants’ knowledge of biomarkers, surrogate markers, and treatment monitoring tools for tuberculosis clinical trials, with a view to improving diagnosis and treatment outcomes.
Topics
- Definitions of biomarkers and surrogate markers as they relate to tuberculosis clinical trials;
- Discussion about UNITE4TB’s TPP and the current state of the art.
- Prediction
Target audience:
- Healthcare Professionals
- Decision Makers
- Policy Makers
- Researchers
- TB Community
Format
Webinar will be divided into 2 parts (of approximately 30 mins. each):
● For the first 30 minutes, the speaker Stephen Gillespie will debate the pros and cons of rolling out new drugs and treatment regimens for TB without diagnostic capacities.
● The second half of the webinar will be filled with an open discussion, moderated by Raquel Duarte and Christoph Lange, giving the opportunity to the participants of sharing perspectives on the topics presented and/or posing questions to the speaker.
Learning outcomes
At the end of this talk, participants will be able to:
- Define the terms biomarker, surrogate marker, and surrogate
- Using these definitions explore the currently available tuberculosis diagnostic tests
- Describe the objectives, constraints and opportunities of monitoring treatment response in clinical trials
- Describe the “soon to be deployed” treatment monitoring tools
- Describe plans for future treatment monitoring tools for clinical trials (the UNITE4TB target product profile)
CME credit
An application for accreditation of this webinar has been made to the European Board for Accreditation in Pneumology (EBAP) for 1 CME credit per 1-hour attendance. If accredited, the CME credit will be granted upon attendance of at least 60 minutes during the live webinar only.
What is a webinar?
A webinar closely simulates a lecture-based teaching experience. The speaker can interact with the audience, just as in a classroom setting. During the webinar, you will be asked to share your opinion on issues related to the topic using interactive polls.
All participants will be able to hear the lecturer and see the slides throughout the presentation. As a participant you will be able to pose questions or discuss ideas with the other participants via the text chat facility and the speaker will respond to the questions via the microphone.
Login guidelines
More information will be communicated in due course.
- Please log in to the webinar 20 minutes before it is scheduled to commence. If you have any technical difficulties whilst trying to log in or during the session please contact e-learning@ersnet.org.
- Check Central European Time.
- To achieve the best quality, we recommend to avoid downloading anything from the internet during your connection to the lecture and stopping all other programmes.
- Please also ensure that your audio settings are not set to mute and adjust the volume to a comfortable level.
Diseases/methods:
- Respiratory infections
- Respiratory Critical Care
Target audience
- Healthcare Professionals
- Decision Makers
- Policy Makers
- Researchers
- TB Community