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<p>In the evolving landscape of clinical research, platform trials have emerged as a revolutionary model, initially designed as a collaborative framework enabling multiple organizations and companies to develop treatments for a single disease under a unified master protocol. Recent years more and more pharmaceutical and biotech companies utilize the framework to screen and prioritize their internal assets, evolving to another type of platform trials with increasing popularity: company sponsored platform trials. This type of platform trials has gained substantial traction and presented unique opportunities and challenges, particularly in the oncology sector, where there are multiple drug candidates being developed as monotherapy or combination therapies within the same organization. To enhance understanding and optimize the conduct of the company sponsored platform trials, the DahShu Innovative Design Scientific Working Group (IDSWG) Oncology Master Protocol subteam conducted cross-industry interviews with professionals involved in seven platform trials from seven different pharmaceutical companies. This paper aims to provide insights into the opportunities and challenges of designing, conducting, and reporting platform trials within a single pharmaceutical company, drawing on the learnings from these interviews.</p>

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Company Sponsored Platform Trials: Recommendations and Lessons Learned from Cross-Industry Interviews

  • 期刊论文

  • 发表日期：

    2025年8月19日

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  • Yujun Wu,
  • Chengxing Cindy Lu,
  • Mehreteab Aregay,
  • Kristine Broglio,
  • Yingwen Dong,
  • Cooner Freda,
  • Wei He,
  • Bo Huang,
  • Nicole Li,
  • Haijun Ma,
  • Peter Mesenbrink,
  • Casey Xu,
  • Lina Yin

摘要

In the evolving landscape of clinical research, platform trials have emerged as a revolutionary model, initially designed as a collaborative framework enabling multiple organizations and companies to develop treatments for a single disease under a unified master protocol. Recent years more and more pharmaceutical and biotech companies utilize the framework to screen and prioritize their internal assets, evolving to another type of platform trials with increasing popularity: company sponsored platform trials. This type of platform trials has gained substantial traction and presented unique opportunities and challenges, particularly in the oncology sector, where there are multiple drug candidates being developed as monotherapy or combination therapies within the same organization. To enhance understanding and optimize the conduct of the company sponsored platform trials, the DahShu Innovative Design Scientific Working Group (IDSWG) Oncology Master Protocol subteam conducted cross-industry interviews with professionals involved in seven platform trials from seven different pharmaceutical companies. This paper aims to provide insights into the opportunities and challenges of designing, conducting, and reporting platform trials within a single pharmaceutical company, drawing on the learnings from these interviews.