Operationalizing Platform Trials

Rationale

Collaborative platform trials surged in use when rapid innovation and efficient patient enrollment during the COVID-19 pandemic was required. Since then, an opportunity to examine more routine use of such designs in areas of high potential has persisted.¹

One area uniquely primed for this collaborative trial design is pediatrics. Challenges around the recruitment of hard-to-reach populations, limited site capacity, and common regulatory requirements across sponsors create an opportunity for cross-industry collaboration to further advance pediatric clinical development.

Collaborative platform trials present a notable degree of complexity to establish and facilitate, such as meeting varying sponsor requirements and a lack of prior experience and tools to navigate upfront planning.²

TransCelerate aims to provide a solution that makes the case for pediatric collaborative platform trials – highlighting past examples of success and lessons learned that will aid sponsors in their engagement with these collaborative trials moving forward.

1.Oakes, K. (2021, April 13). Woodcock: Post-COVID, new flexibility could boost cancer trial diversity. Regulatory Affairs Professionals Society. https://www.raps.org/news-and-articles/news-articles/2021/4/woodcock-post-covid-new-flexibility-could-boost-ca

2.Koenig, F., Spiertz, C., Millar, D., Rodríguez-Navarro, S., Machín, N., Van Dessel, A., Genescà, J., Pericàs, J. M., & Posch, M. (2024). Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL. eClinicalMedicine, 67, 102384. https://doi.org/10.1016/j.eclinm.2023.102384

Benefits