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Labeling Comprehension Studies Found to Reduce Medical Product Risk and Accelerate Regulatory Approval

Posted on: Thursday, 20 March 2008, 06:00 CDT

Patient Based Research (PBR), a privately held specialty contract research organization, announced today the release of a new White Paper titled "Labeling Comprehension Studies: Mitigate Medical Product Risk and Accelerate Regulatory Approval."

According to recent studies conducted by PBR, drug-device combination products have potential utilization error rates as high as 40% or more. Early comprehension testing of proposed labeling can identify problem areas that may lead to a potential medication or administration error or user frustration resulting in medication non-compliance. Results can be utilized to revise labeling prior to product launch, and effectively reduce the risk for medication errors once the product has been commercialized.

PBR's White Paper cites several case studies where labeling comprehension, compliance and product usability studies have revealed surprisingly poor initial product safety and performance results by patients, caregivers, and pharmacists. In all cases, product trial research (simulated use study) was utilized and labeling comprehension was revealed as a major source of end use confusion. Studies were conducted to simulate as close as possible real healthcare practice dynamics to evaluate the labeling effectiveness. In the studies, observational methods were utilized to make recommendations for labeling revisions which led to a 50% or more reduction in product use and medication error rates. Compared to the cost of traditional clinical trials, labeling comprehension studies using PBR's mock product use trial methods are significantly more economical.

According to Peter Westkaemper, PBR's Executive Vice President of Regulatory Affairs, "In our experience, a well-designed trial where product use is simulated by patients has correlated well with actual field results. The evaluation of labeling comprehension prior to commercialization can significantly reduce product use errors with the potential outcome of improved safety, efficacy, and competitiveness."

To access a copy of the White Paper, please visit www.patientbasedresearch.com

About PBR

PBR is a specialty contract research organization (CRO) focused on peri-approval studies including patient registries, labeling comprehension and compliance, and pre-market and post market product evaluations. PBR's team is a unique blend of experienced clinical, regulatory, quality systems, market research and biostatistics professionals who provide innovative research services in a timely and cost-effective manner.

For addition information, or to request a copy of the White Paper, contact: Larry Risen, Patient Based Research, 760-448-4823, risen@patientbasedresearch.com.

www.patientbasedresearch.com

Source: Business Wire

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