Experts from around the globe discuss the concept and challenges of platform trials in clinical research. They explore the efficiencies, funding issues, and statistical considerations of transitioning to big team science. The role of patient groups in trial designs and the challenges of educating institutional review boards and securing funding are also highlighted.
Educating IRBs on platform trial flexibility is vital for ethical oversight.
Proficient statistical teams are crucial for navigating complex trial designs.
Patient and public engagement in platform trials enhances transparency and relevance.
Deep dives
Platform Trials: A New Approach in Clinical Research
Platform trials have introduced a shift in traditional clinical research methodologies by focusing on efficiency and adaptability. These trials allow for flexibility in sample sizes and the incorporation of new interventions without the need for fixed numbers. Educating institutional review boards and ethics committees on the continuous nature of platform trials is crucial to ensure proper oversight. The use of a core protocol supplemented by specific intervention documents aids in this process, ensuring transparency and review of new therapies.
Statistical Considerations and Adaptive Design in Platform Trials
Statistical complexities in platform trials, such as adaptive designs and responsive randomization, require a proficient statistical team to navigate effectively. Considerations around secular trends, background therapies, and control populations changing over time necessitate careful modeling and analysis to preserve trial integrity. Institutions and funding bodies are adapting to support platform trials, recognizing the importance of efficient utilization of resources and collaborative global initiatives.
Engaging Patient and Public Involvement in Platform Trials
Patient and public engagement play a crucial role in platform trials, shaping research priorities and ensuring community involvement. Leading platform trials often involve patient groups in trial design and decision-making, fostering a collaborative approach. By educating and engaging diverse stakeholders, including patients, in the trial process, researchers enhance transparency, accountability, and relevance of the research.
Adressing Resource Limitations in Low-Income Settings Through Platform Trials
Platform trials offer opportunities for cost-effective evaluation in low and middle-income settings by streamlining research processes and maximizing site recruitment. Collaborations between high-income and low-income countries enable efficient utilization of resources and knowledge sharing. Tailoring platform trials to suit local contexts and building research capacity in these settings enhance global health equity and research accessibility.
Future Directions and Global Collaboration in Platform Trials
As platform trials evolve, a focus on solidarity, capacity building, and tailored implementation in diverse settings is paramount. Diverse funding sources, including philanthropic foundations and global health organizations, support the expansion of platform trials globally. Emphasizing ownership, capacity development, and local leadership in platform trial initiatives promotes sustainable and inclusive research practices.
Bala Venkatesh (Brisbane) hosts a panel discussion entitled "Beyond Platform Trials" at the Critical Care Reviews Meeting 2023. The panellists include Bronagh Blackwood (Belfast), Susan Rowell (Chicago), Fernando Zampieri (Edmonton), Marion Campbell (Aberdeen), David Harrison (London), Roger Lewis (Los Angeles), Derek Angus (Pittsburgh) & Kathy Rowan (London).
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