ESO Trials Alliance Webinar – Update on trial activity in ESOTA
Report by Aristeidis H. Katsanos, MD, PhD
Dr. Robin Lemmens started by introducing ESOTA, a network of networks for stroke trials in Europe, and presented an overview of the webinar program.
Dr. Peter Kelly was the first speaker providing an update on the CONVINCE trial and discussing on the lessons he learned from leading an international stroke prevention trial. CONVINCE started in 2016 randomizing patients with non-severe, non-cardioembolic stroke to either low-dose colchicine or placebo. Based on his experience Dr. Kelly provided 9 key advices for leading a successful international clinical trial:
- Pick interventions for a study with promising data and those that have a well-established pathophysiological mechanism.
- Keep the trial design simple in terms of eligibility criteria, intervention delivery, study procedures and trial management.
- Use a flexible approach to funding. Start with a pilot trial, get some initial funding and built on that.
- Focus on plan and resource trial set-up (expect it to take more than 12-18 months).
- Work with a great team. Collaborate with experienced and reliable team members.
- Centralize procedures where possible. Remote procedures are really important during pandemics.
- Value collaborating site teams.
- Be efficient. Consider using adaptive platform trials designs, where possible.
- Don’t fear failure! Clinical trials are extremely valuable, even if the results are neutral or negative.
Then Dr. Gotz Thomalla discussed on the challenges of coordinating an international thrombectomy trial. Dr. Thomalla presented the TENSION trial, a randomized controlled clinical trial assessing the utility of endovascular thrombectomy treatment for acute ischemic stroke patients presenting with extended lesions at baseline scans (ASPECTS score 3-5) and at an extended time window (within 12 hours from symptom onset). Based on his experience setting up the TENSION trial Dr. Thomalla summarized the barriers in the implementation of international multicenter acute stroke trials:
- Concluding the contracts in different sites and countries – being highlighted multiple times as the major consideration.
- Disparity in the agreement for data protection between countries.
- Time-consuming approval processes due to specific national requirements.
- Restriction in research activities and site activation as a result o the COVID-19 pandemic.
- Challenges in sending anonymized images to core labs.
- Univocal approach to serious adverse event (SAE) management and documentation system.
Dr. Nikola Sprigg was the last speaker of the webinar and presented the rationale and protocol of the TICH-3 trial, a randomized controlled clinical trial investigating the use of tranexamic acid for patients with acute intracranial hemorrhage (ICH). Dr. Sprigg summarized the lessons she learned from the TICH-2 trial, which have informed the design of the TICH-3 trial in terms of population and primary endpoint selection. Dr. Sprigg suggested that simple trials that target at a population with the greatest potential to benefit have higher odds of success. Dr. Sprigg highlighted that time is critical in emergency conditions and presented the paradigm of TICH-3 being designed as a pragmatic trial with a rapid emergency process for consent. According to Dr. Sprigg rapid enrolment, simple randomization, minimal data entry and no need for additional imaging requirements are the key elements to facilitate success of an acute ICH trial by reducing the burden of participating sites. Discussing further on the challenges for the implementation of an acute ICH trial using hemostatic agents Dr. Sprigg highlighted insurance, contracts, drug availability, COVID-19 pandemic, and the use other competing hemostatic agents as potential barriers for a successfully implementation.