Posted by Michael Wonder on 18 Dec 2018
Establishing the effectiveness of procedural interventions: the limited role of randomised trials
18 December 2018 - Procedural interventions comprise a large and growing component of medical care. Patients, physicians, health care organisations, and payers are highly motivated to determine the safety and effectiveness of these interventions.
Large randomised clinical trials (RCTs) are widely accepted as having the greatest internal validity and thus provide the highest-quality evidence to guide practice. RCTs have been widely adopted as a prerequisite for licensing new pharmaceuticals. However, there are substantial barriers to conducting and implementing RCTs in the evaluation of procedural interventions, such as the role of robotic surgical approaches to rectal cancer.
Even though these barriers have been long recognised, the proliferation of new and often costly technologies, coupled with changes in the regulatory environment, suggest new approaches may be necessary to approve devices.
