CenterWatch Monthly November 2009

Monday, November 2, 2009 06:14 AM

How Investigative Sites Are Making it in Tough Times

During these difficult economic times, a number of investigative sites have been forced out of business or experienced severe cash crunches, squeezed by canceled projects, late payments from sponsors and tight study budgets. But sites are now seeing an uptick in studies as the year winds down, which they hope will continue into 2010.

Site personnel offer a number of suggestions on how to survive the lean stretches and how to prosper when the studies start flowing again.

 

AAHRPP Revises Accreditation Standards, Looks to Accredit HRPPs Outside North America

Eight years after its launch, the Association for the Accreditation of Human Research Protection Program is streamlining the process for achieving accredited status and is proposing to place more emphasis on conflict of interest.

As the number of accredited programs grows, there are still many who have not chosen to seek accreditation. The majority of stakeholders, including a pharmaceutical giant and the National Institutes of Health, recently concluded that accreditation is essential.

 

NRES Shares Ambitious Plans for 2010

The National Research Ethics Service (NRES) wants to streamline the research ethics committee application approval process and better equip research ethics committee (REC) members to make approval decisions. NRES, established in 2007 within the National Patient Safety Agency and dedicated to protecting research participants as well as to facilitating and promoting ethical research, made its goals known when it recently released its plans for fiscal year (FY) 2009-2010.

 

Eye On: Skin Conditions

Most skin conditions share a common pathophysiology of excessive inflammation. Acne, a skin condition with acute and often chronic cosmetic changes, including scarring, is characterized by sebaceous gland inflammation, stimulated by increased levels of androgens and other hormones.

 To read the full articles for this issue or for more information on these and other breaking stories, please click here for subscription information.

 

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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