New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development
18 Juin 2009 - 9:00AM
PR Newswire (US)
Study Examines Impact of Regulatory Changes on Pharma Industry
DUBLIN, June 18 /PRNewswire-FirstCall/ -- According to a report
issued today, drug safety leaders in pharmaceutical and
biotechnology companies recognise the need to increase resources,
either internally or through partnerships, to comply with the
safety regulations recently issued by the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMEA). The
report - Safety First: The Impact of New Regulations on Clinical
Development - is based on a survey of 140 industry safety
specialists, including heads of medical, drug safety,
pharmacovigilance, and regulatory departments within large and
mid-sized pharmaceutical companies and biotech firms. The survey
found that more than three-quarters (77%) of respondents believe
that new safety regulations have had a considerable impact on the
industry as companies implement drug safety regulations throughout
the clinical development process. The FDA and EMEA have recently
introduced more rigorous safety regulations, with a particular
emphasis on post-marketing surveillance, to ensure that medications
are monitored for their safety and effectiveness over the long
term, across wide populations, and in real-life settings. The
survey findings also highlighted regulatory departments in
particular as having a pressing need for greater resources, with
more than half of those surveyed (53%) requiring resources within
the next six months. "The transition from performing passive
post-marketing surveillance to active safety monitoring using Phase
IV studies, safety registries and comparative effectiveness
programmes, is to ensure that benefit/risk re-assessment continues
as safety information on the real-world use of products is
revealed. Although initially resource intensive, this more rigorous
approach to obtaining and analysing post-approval safety data will
better ensure the public's confidence in a product's true safety
profile. The real challenge will be to find better tools and novel
approaches to implement the requirements of regulations efficiently
and cost effectively," says Dr. Suzanne Gagnon, Chief Medical
Officer, ICON Clinical Research. The report was commissioned by
ICON plc, a global provider of outsourced development services to
the pharmaceutical, biotechnology and medical device industries,
and developed by IMS Health, the world's leading provider of market
intelligence to the pharmaceutical and healthcare industries. Phase
IV activities, including observational trials or "safety
registries" that gather data on the use and effectiveness of
medications in the real world are expected to be particularly
impacted by new regulations, according to the survey. Eighty
percent of respondents anticipate the number of Phase IV trials to
grow over the next five years, while 58 percent indicated 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," says Nigel Burrows, Senior
Principal, Management Consulting, IMS. "The pharmaceutical industry
has and continues to respond to this challenge, both in drug
clinical development and commercialisation. 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."
Notes to editors Survey methodology ICON commissioned IMS Health to
conduct a survey that explored global trends in drug safety issues,
and to evaluate the impact of recent safety regulations on the
industry. A total of 140 people were questioned via a telephone
interview, and included the heads of pharmacovigilance, safety and
clinical research functions among pharmaceutical and biotechnology
companies. Respondents included 59 from large pharmaceutical
companies, 56 from mid-size pharma companies and 25 from biotech
companies. All respondents have global or regional-level
responsibilities. Analysis and insight are based on interview
responses. Confidence levels of 90% were applied to analyze
statistically significant differences within the results. About
ICON ICON plc is a global provider of outsourced development
services to the pharmaceutical, biotechnology and medical device
industries. The Company specialises in the strategic development,
management and analysis of programs that support clinical
development - from compound selection to Phase I-IV clinical
studies. With headquarters in Dublin, Ireland, ICON currently,
operates from 71 locations in 38 countries and has approximately
7,100 employees. Further information is available at
http://www.iconplc.com/ DATASOURCE: ICON plc CONTACT: Susan
Dempsey, T: +353(0)1-291-2057, M: +353(0)86-854-2896, Courtney
Judd, , +1-212-445-8365
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