Joint Clinical Assessments Of ATMPs Add To Ethical Concerns Over Need For Randomized Trials

Advances in cell and gene therapy, together with the forthcoming EU joint clinical assessments, have raised questions about the ethics of having to use randomized controlled trials to test new advanced therapies.

accelerating development — RCTs and Single-arm studies merit a wider ethical discussion • Source: Shutterstock

Much wider discussions on the merits of using single-arm trials versus randomized controlled trials (RCTs) for developing advanced therapies are needed if regulators, industry and patients want to ensure quicker access to these treatments, said speakers at the 2024 Cell and Gene Therapy Meeting on the Med, organized by the Alliance for Regenerative Medicines (ARM).

The forthcoming EU-wide joint clinical assessments (JCAs) that go live in January 2025 mean the matter is more pressing than...