Navigation Links
New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development
Date:6/18/2009

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


'/>"/>
SOURCE ICON plc
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:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... Summary GBI ... a Key Component of Multichannel Marketing" provides a ... in the digital age. While the pharmaceutical ... advancements, it has been much slower to adopt ... traditional channels and methods. However, the decreasing effectiveness ...
(Date:3/28/2017)... 2017  Orexigen Therapeutics, Inc. (Nasdaq: OREX ... fourth quarter and year ended December 31, 2016. ... progress for Orexigen, beginning with the re-acquisition of the ... March, the team at Orexigen demonstrated remarkable focus, executing ... and strengthened our Company while rewarding us full control ...
(Date:3/28/2017)... and TORONTO , March 28, 2017 ... leading full service medical device development firm, announced today ... Toronto -based medical device industrial design ... serve medtech companies throughout North America ... experienced medical device talent spanning the design, engineering, regulatory, ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... For many women, getting birth control isn’t as easy as it ... either don’t have access to a health care facility or a pharmacy within 60 minutes ... the United States or for many who are faced with health or personal issues that ...
(Date:3/28/2017)... SEATTLE, Washington and CARTERSVILLE, Georgia (PRWEB) , ... ... ... adding another senior analyst to its award-winning team. Ruel Williamson brings his extensive ... Advisors, which has been a leader in the real estate valuation industry for ...
(Date:3/28/2017)... ... March 28, 2017 , ... Revolution for Truth has ... to protect parental rights and civil liberties, and to restore transparency within government ... demonstration coincides with a press conference taking place Friday morning calling on President ...
(Date:3/28/2017)... ... , ... Dr. Isabella Wentz, PharmD, FASCP, one of the leading thyroid experts ... Secret. Dr. Wentz talked about journey and research recently on a blog and discussed ... the only solution to deal with thyroid disease. , Dr. Wentz completed her ...
(Date:3/28/2017)... ... March 28, 2017 , ... Medforce Technologies, Inc., a leading ... it has joined the National Association for Home Care and Hospice (NAHC), the ... and dying Americans of all ages and the caregiver who provide them with ...
Breaking Medicine News(10 mins):