Trial Talk

Episode 8: International Clinical Trials Methodology Conference 2024 roundup - Early Careers Edition

At the start of October, lots of the Unit’s clinical trials methodology researchers travelled to Edinburgh, for the 7th International Clinical Trials Methodology Conference (ICTMC). ICTMC is the largest academic-led conference on clinical trials, bringing together trialists from across the globe to present their latest work in trials methodology. This year's conference featured a wide variety of workshops, talks and poster presentations from MRC Clinical Trials Unit researchers. I n this latest episode of the Trial Talk podcast, four of the Unit’s early career researchers discuss the work they presented at ICTMC 2024. Gideon Darko Asamoah tells us how he will deliver a core outcome set for trials in severe malaria; Jingyi Xuan describes her project addressing intercurrent events in platform trials; Dongquan Bi discusses the effects of different cluster sizes in cluster trials; and finally, Kate Roberts explains how she aims to improve the wording around consent for accessing trial participants' healthcare records. For questions or feedback on the series, message us at mrcctu.engage@ucl.ac.uk [mrcctu.engage@ucl.ac.uk] For more information and to access the transcript: bit.ly/4f9grVi As a listener, your opinion is very valuable to us. Please help us to improve the podcast in future by filling in this short survey: forms.office.com/e/PjfjQ5Mn6g More resources: • Developing a core outcome set for severe malaria trials poster: www.mrcctu.ucl.ac.uk/posters/identi…nd-caregivers/ [http://www.mrcctu.ucl.ac.uk/posters/identi%E2%80%A6nd-caregivers/] • Specifying estimands and estimators in trials with complex designs poster: www.mrcctu.ucl.ac.uk/posters/specif…mplex-designs/ [http://www.mrcctu.ucl.ac.uk/posters/specif%E2%80%A6mplex-designs/] • Demystifying estimands in cluster-randomised trials paper in Statistical Methods in Medical Research: journals.sagepub.com/doi/10.1177/09622802241254197 • Estimands in cluster-randomised trials paper in International Journal of Epidemiology: academic.oup.com/ije/article/52/1/107/6644521 • Current practice around the use of estimands in cluster randomised trials, and the impact of informative cluster size on inference poster: www.mrcctu.ucl.ac.uk/posters/curren…on-inferences/ [http://www.mrcctu.ucl.ac.uk/posters/curren%E2%80%A6on-inferences/] • ICTMC 2024 Poster 167 – A rap song (Lyrics by Dongquan Bi, beat by David Fitzgerald): youtu.be/s7qZ5TnOlWU?si=iXwfFfSAWwJ-fAmk • CrossWord poster: www.mrcctu.ucl.ac.uk/posters/crossw…ing-materials/ [http://www.mrcctu.ucl.ac.uk/posters/crossw%E2%80%A6ing-materials/]  Date of episode recording: 2024-10-30T00:00:00Z  Duration: 00:25:09  Language of episode: English  Presenter:Charlotte Hartley  Guests: Gideon Darko Asamoah, Jingyi Xuan, Donguan Bi, Kate Roberts  Producer: Charlotte Hartley

Episode 7: Preventing multidrug-resistant tuberculosis

In September 2024, the World Health Organization (WHO) released new guidance on preventative treatment for tuberculosis (TB). Thanks to new evidence from two randomised controlled clinical trials, the WHO now recommends that contacts of people with multidrug-resistant TB take six months of daily levofloxacin. In this episode of the Trial Talk podcast, we find out more about the TB-CHAMP and VQUIN trials. We also learn how the teams came together to combine their data and strengthen their evidence, using new statistical methodologies developed at the MRC Clinical Trials Unit at UCL. The episode features interviews with Anneke Hesseling, Principal Investigator for TB-CHAMP, based at Stellenbosch University, and Trinh Duong, based at the MRC CTU at UCL, the trial statistician for TB-CHAMP and lead for the combined data analysis with VQUIN. For questions or feedback on the series, message us at mrcctu.engage@ucl.ac.uk [mrcctu.engage@ucl.ac.uk] For more information and to access the transcript: bit.ly/3XTf8na [https://gate.sc/?url=http%3A%2F%2Fbit.ly%2F3XTf8na&token=de6b72-1-1727277861462] As a listener, your opinion is very valuable to us. Please help us to improve the podcast in future by filling in this short survey: forms.office.com/e/PjfjQ5Mn6g [https://gate.sc/?url=http%3A%2F%2Fforms.office.com%2Fe%2FPjfjQ5Mn6g&token=ddf97b-1-1727277861462] Date of episode recording: 2024-09-23 Duration: 00:32:50 Language of episode: English Presenter:  Charlotte Hartley Guests:   Anneke Hesseling, Trinh Duong Producer:   Charlotte Hartley

Episode 6: The OPTIC study: Patient views on optimising immunotherapy in cancer

Optimisation immunotherapy clinical trials investigate ways of reducing the intensity of immunotherapy cancer treatment. This could be beneficial for patients’ quality of life. But these trials can be challenging to run, as patients may be concerned about the impact that reducing the intensity of treatment could have on the cancer. This episode of the Trial Talk podcast focuses on the MRC Clinical Trials Unit at UCL’s OPTIC study, which explores how people with cancer feel about taking part in optimisation immunotherapy trials. Clinical Fellow Sophie Merrick discusses the main barriers that patients face and recommendations to address them. Resources: •OPTIC study page: www.mrcctu.ucl.ac.uk/studies/all-st…/refine/optic/ [https://gate.sc/?url=http%3A%2F%2Fwww.mrcctu.ucl.ac.uk%2Fstudies%2Fall-st%E2%80%A6%2Frefine%2Foptic%2F&token=fe6945-1-1719834336410] •OPTIC results paper: www.nature.com/articles/s41416-024-02756-x.pdf [https://gate.sc/?url=http%3A%2F%2Fwww.nature.com%2Farticles%2Fs41416-024-02756-x.pdf&token=a556bc-1-1719834336410] •REFINE podcast episode: on.soundcloud.com/Fe3C76csHkgCg2or5 [http://on.soundcloud.com/Fe3C76csHkgCg2or5] For questions or feedback on the series, message us at mrcctu.engage@ucl.ac.uk [mrcctu.engage@ucl.ac.uk] For more information and to access the transcript: bit.ly/4c9SfAr [https://gate.sc/?url=http%3A%2F%2Fbit.ly%2F4c9SfAr&token=b56f5c-1-1719834336410] As a listener, your opinion is very valuable to us. Please help us to improve the podcast in future by filling in this short survey: forms.office.com/e/PjfjQ5Mn6g [https://gate.sc/?url=http%3A%2F%2Fforms.office.com%2Fe%2FPjfjQ5Mn6g&token=d66048-1-1719834336410] Date of episode recording: 2024-06-18T00:00:00Z Duration: 00:25:23 Language of episode: English Presenter: Berta Terre-Torras Guests: Sophie Merrick Producer: Berta Terre-Torras

Episode 5: Patient and Public Involvement (PPI) in clinical trials

The MRC Clinical Trials Unit at UCL is committed to actively involving patients and the public in our trials. All our Patient and Public Involvement (PPI) work is overseen by our PPI Group, made up of MRC CTU staff alongside seven patient representatives, with a wide range of experience in different areas. In this episode of the Trial Talk podcast, two members of the Unit’s PPI Group, Richard Stephens and Ian Newsome, discuss what PPI means to them; how they got involved as patient representatives in clinical research; and how the MRC CTU at UCL embeds PPI into our trials. Resources: • Our PPI group: www.mrcctu.ucl.ac.uk/patients-publi…our-ppi-group/ [http://www.mrcctu.ucl.ac.uk/patients-publi%E2%80%A6our-ppi-group/] • PPI resources: www.mrcctu.ucl.ac.uk/patients-publi…ppi-resources/ [http://www.mrcctu.ucl.ac.uk/patients-publi%E2%80%A6ppi-resources/] • Testing Treatments: Better Research for Better Healthcare (book): www.ncbi.nlm.nih.gov/books/NBK66204/ [http://www.ncbi.nlm.nih.gov/books/NBK66204/] For more information and to access the transcript: bit.ly/3KlKtak For questions or feedback on the podcast series, message us at mrcctu.engage@ucl.ac.uk [mrcctu.engage@ucl.ac.uk]  As a listener, your opinion is very valuable to us.  Please help us to improve the podcast in the future by filling in this short survey: forms.office.com/e/PjfjQ5Mn6g  Other details:  Date of episode recording: 2024-05-29T00:00:00Z  Duration: 00:34:43  Language of episode: English  Presenter:Charlotte Hartley  Guests: Ian Newsome, Richard Stephens  Producer: Charlotte Hartley

Episode 4: Estimands - Answering the right research questions

An estimand is a description of the research question a trial seeks to answer, which can help researchers better understand how their study should be designed and analysed. Estimands also provide a clear way to communicate treatment effects to different stakeholders. This episode of the Trial Talk podcast features Principal Research Fellow Brennan Kahan, exploring how triallists could benefit from using estimands. Brennan also discusses his recent paper which aims to demystify new guidance on the use of estimands. Resources: • The estimands framework: a primer on the ICH E9(R1): www.bmj.com/content/384/bmj-2023-076316 [http://www.bmj.com/content/384/bmj-2023-076316] • 'We must let the research question drive study methods' opinion piece: www.ncbi.nlm.nih.gov/pmc/articles/PMC9908044/ [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9908044/] • Estimands in cluster-randomized trials: choosing analyses that answer the right question: www.ncbi.nlm.nih.gov/pmc/articles/PMC9908044/ [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9908044/] For more information and to access the transcript: bit.ly/4dazsWF For questions or feedback on the podcast series, message us at mrcctu.engage@ucl.ac.uk [mrcctu.engage@ucl.ac.uk]  As a listener, your opinion is very valuable to us. Please help us to improve the podcast in the future by filling in this short survey: forms.office.com/e/PjfjQ5Mn6g  Date of episode recording: 2024-04-25T00:00:00Z  Duration: 00:21:29  Language of episode: English  Presenter: Charlotte Hartley  Guests: Brennan Kahan  Producer: Charlotte Hartley