Greater Than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations

"Greater Than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations." The American Journal of Bioethics, 20(4), pp. 102–103

This article is referred to by:

Balancing Risk and Reward: Greater Research Oversight Is Appropriate for Novel Therapies for Children With Life-Limiting Illness

Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Pediatric Conditions

Balancing Scientific Progress With Pediatric Protections: No Direct Benefit Now, But Potential Novel Therapy in the Future

Bringing Known Drugs to Pediatric Research: Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk

The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials

When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Pediatric Study Population

DISCLOSURE STATEMENT

Liza-Marie Johnson and Benjamin S. Wilfond are the coeditors and Devan M. Duenas is the managing editor. This case was contributed by Akshay Sharma and Liza-Marie Johnson.

Additional information

Funding

The challenging cases in research ethics series is supported by the Institute of Translational Health Sciences [UL1 TROO2319] with a CTSA award from the National Center for Advancing Translational Research.