Navigation Links
New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development

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

Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily
2. AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA
3. Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barretts Esophagus
4. Living Donor Kidney Transplants Using Alemtuzumab Pre-Conditioning and Tacrolimus Monotherapy: Long-Term Safety and Efficacy
5. Results and Additional Analyses From Efficacy and Safety Study of Cortheras Relaxin in Acute Heart Failure to be Presented at Heart Failure Congress 2009
6. VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction
7. New Study Suggests Rx Estrogen Delivery Through the Skin May Show Safety Benefits as Opposed to Oral Delivery
8. Results From Study Show Promising Efficacy and Safety Results for Cortheras Relaxin in Acute Heart Failure
9. Clinical Data Reinforce Safety and Efficacy of Boston Scientifics Two Drug- Eluting Stent Platforms
10. RenalGuard(R) Pilot Safety Clinical Trial Data to be Presented at ACC 2009
11. Results From Efficacy and Safety Study of Cortheras Relaxin in Acute Heart Failure to be Presented at Late-Breaking Clinical Trials Session at ACC 58th Annual Scientific Session
Post Your Comments:
(Date:11/24/2015)... Avery Biomedical Devices (ABD), manufacturer of the ... appointment of Anders Jonzon , MD; Ph.D. as ... Dr. Jonzon is a Physiologist and consultant ... University, Uppsala and Children,s Hospital, Karolinska, Stockholm, ... at the Cardiovascular Institute (UCSF). His research has covered ...
(Date:11/24/2015)... LAUSANNE and BERN, Switzerland ... SA, the ARTORG Center for Biomedical Engineering Research of ... and the Division of Endocrinology, Diabetes and Clinical Nutrition ... announce the start of an exclusive collaboration to develop ... control algorithm for the personalised delivery of insulin for ...
(Date:11/24/2015)... Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today that ... Education and Human Resources will be presenting in the upcoming ... Plan Strategies for a Dynamic Market" on Dec. 1, 2015. ... consultant with the Cambridge Advisory Group, where she leads their ... The webinar will discuss the rapid growth of oral oncolytics, ...
Breaking Medicine Technology:
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Dr. Rodney E. Willey , has ... new venture, Koala Center for Sleep Disorders, provides treatment for snoring and sleep apnea ... have opened a Koala Center for Sleep Disorders in the US, one of four in ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... and Healthy Aging Program have announced their endorsement of the Medical Fitness ... Health Fitness is proud to have the MFN as one of our endorsed ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Autism Speaks, the ... global movement driven by social media and the generosity of people around the world. ... their social media networks to give – and share the personal stories behind those ...
(Date:11/24/2015)... Miami, FL (PRWEB) , ... November 24, 2015 ... ... manufacturer and engineer of patented products, announces Innovative Blending, a household invention that ... go. , "The Juice & Smoothie Bars market is worth $2 billion," says ...
(Date:11/24/2015)... ... November 24, 2015 , ... Robert Yeager CEO of PharmMD, has ... past year there have been multiple breakthroughs and challenges as healthcare reform moves out ... enabled their customers and partners to stay ahead of the curve by breaking down ...
Breaking Medicine News(10 mins):