Neonatology has undoubtedly benefited from clinical trials. Nevertheless, more treatments based on inadequate experimental evidence are given than those that are supported by a validated evidence base. Clinicians seeking the basis for their current and future clinical practice are faced with challenges in the shadow of recent UK legislation and government recommendations. All patients must be protected from inappropriate research, but the benefits of regulations must be appropriately balanced with those of properly conducted clinical trials. It is ethically difficult both to persist with treatments of unproven benefit and unknown harm and to deny infants potentially valuable therapies. It is important that trials are conducted within the new legislative framework, but their future may rest with innovative solutions and the determination of all involved in the process.
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Competing interests: TS is a member of the Committee on Safety of Medicines of the Medicines and Healthcare products Regulatory Agency and is a Clinical Specialty Advisory to the National Patient Safety Agency. TS has received support for travel to academic meetings and honoraria for lecturing from several commercial companies connected with neonatal medicine.
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