Mediocre Data Stymies Benefit/Risk Assessment
By: John Doyle, DrPH, MPH | August 29, 2013
The data currently used to assess the benefits and risks of a new biopharmaceutical product is not delivering the level of value or confidence that the industry would like -- this is according to Quintiles’ latest survey of US and UK healthcare industry stakeholders for our 2012 New Health Report.
In the survey, we asked biopharma executives, and US and UK payers to rate the effectiveness of different types of data, including patient reported outcomes, minimal clinical efficacy, and quality adjusted life years. And the results for almost every category were similarly average. While 60-75 percent of stakeholders rate every type of data as “good” for assessing the risk benefit profile of a drug, less than 20 percent of them – and in many cases fewer than 10 percent – rank any of these data points as ‘excellent’ in the assessment process.
These results reinforce the notion that there is no silver bullet for assessing the risk and benefit profile of a new product. The fact that every data type received mediocre scores, shows that while all of this data together is useful, none of it offers the definitive answer we seek.
These results could be viewed as discouraging. However, the lack of ‘excellent’ responses also points to potential opportunities for industry leaders to do a better job at developing standardized and harmonized methodologies for measuring risk and benefit quantitatively. If we can improve the methods by which we accumulate this data, we can better manage risks and improve benefits for everyone involved.
To see the full results of the survey, download the 2012 New Health Report.