Innovative Trial Design and Re-Imagined Endpoints with Richard Nkulikiyinka

Transformation in Trials

Understand the complexities of clinical trial design from a seasoned expert. We speak to our esteemed guest, Richard Nkulikiyinka , a senior leader in clinical development. Richard illuminates the often-misunderstood world of trial design, from setting objectives and identifying target populations to the nitty-gritty like data collection, visit schedules, and maintaining quality. The spotlight shines on patient-centric approaches, as Richard persuasively argues for designing trials that are more patient-friendly without sacrificing quality.
As we go deeper into the conversation, we reveal the intriguing process of creating and accepting endpoints for various diseases. Richard presents a compelling case study of heart failure trials, debunking the notion that traditional endpoints are always the best fit. He illustrates how a novel endpoint for counting all hospitalizations was innovatively developed and accepted by health authorities — a process that holds potential for other diseases reducing exercise capacity.
But it's not all about the technicalities. We also underscore the crucial role of collaboration in developing endpoints. To illustrate this, Richard shares his experience charting the benefits of pre-competitive collaboration between industry partners, academic institutions, and health authorities. We also navigate the challenges of innovating clinical trials, discussing the constraints of mega trials and escalating costs, and the collective effort needed to accelerate the development of new therapies. Get ready to reimagine the future of clinical trials with this enlightening discussion!

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1. Innovative Trial Design and Re-Imagined Endpoints with Richard Nkulikiyinka (00:00:00)

2. Novel Trial Design and Endpoints (00:00:13)

3. Clinical Trials (00:11:11)

4. Importance of Collaboration in Development Endpoints (00:26:26)

5. Innovating Clinical Trials for Drug Development (00:31:02)

6. Guest's Wish for Industry Change (00:40:25)