Summarizing Single-Arm Studies For Use As A Registrational Study In Oncology

In a webinar summary, authors recall a discussion among industry experts regarding the preference for randomized, controlled clinical trials (RCTs) as the FDA-endorsed method for conducting registrational studies in developing new drugs and biologics. However, within the field of oncology, specific situations may warrant consideration of single-arm trials due to the disease's severity, the absence of effective treatments, and the practical challenges associated with RCTs.

In these particular contexts, opting for a single-arm trial can expedite the development of new oncology treatments, reduce the time needed for product approval and patient access, and offer evidence of clinical benefits for innovative products on a smaller patient population.

Explore insights from Versistat's Vice President of Strategic Consulting, Robin Bliss, PhD, Strategic Consulting Fellow and Biostatistician, Debora Manning, MPH, and Principal Regulatory Strategist, Toni Marie Nearing, BS, as they discuss single-arm oncology registrational studies, recount success stories, and share valuable lessons learned.

The article covers key themes, including:

• Single-arm trials can be used as registrational studies in oncology when they meet certain criteria.
• Using a single-arm trial for registration must follow certain foundational steps.
• Regulatory strategy for single-arm trials can be informed by building collaborative relationships with
  authorities.