ICON Report Highlights Need for Resources to Meet New Safety Regulations
A new report released by ICON last week says new safety regulations have created a greater demand for resources to ensure those regulations are met.
The report is based on a survey, commissioned by ICON and market intelligence firm IMS Health, of 140 industry safety specialists within large and mid-size pharmaceutical companies.
According to "Safety First: The Impact of New Regulations on Clinical Development," 77% of respondents said new safety regulations have had a considerable impact on the drug development industry, and 53% of those surveyed highlighted their regulatory departments in particular as requiring resources within the next six months.
Respondents to the survey said they anticipate phase IV trial activity will grow in the next five years, and 58% said that safety registries increasingly will be used to monitor drug safety at every stage of the clinical trial process.
"The move toward greater transparency around drug safety remains a regulatory and political priority worldwide," said Nigel Burrows, senior principal, management consulting, IMS. "The pharmaceutical industry has and continues to respond to this challenge, both in drug clinical development and commercialization. These efforts have the potential to go beyond simply satisfying regulatory requirements, leading to more clinically effective and commercially viable advances that improve outcomes and set new standards of care."