Ethics/Regulatory

EMA scientific advice leads to higher success rates, shorter assessment times

Tuesday, April 21, 2015 07:58 AM

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorization application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorization.

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Quest Diagnostics

WCG encourages its global research network to use ACTA as clinical trial contract solution

Monday, April 20, 2015 06:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

Global IRB WIRB-Copernicus Group (WCG) today said it will encourage the 1,200 members of its global research network to accept and use the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multicenter clinical trials.

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Obama administration releases National Action Plan to combat antibiotic-resistant bacteria

Thursday, April 2, 2015 12:59 PM

The White House has released a comprehensive plan that identifies critical actions to be taken by key Federal departments and agencies to combat the rise of antibiotic-resistant bacteria. The National Action Plan for Combating Antibiotic-Resistant Bacteria, which was developed by the interagency Task Force for Combating Antibiotic-Resistant Bacteria in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria, outlines steps for implementing the plan.

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NIH forms team to chart course for Precision Medicine Initiative research network

Wednesday, April 1, 2015 01:08 PM

A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design and what success would look like five and 10 years out.

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Report: Transparency, cooperation help reduce high prices for new medicines

Friday, March 27, 2015 11:19 AM

As the number of new medicines introduced in Europe rises, governments are finding it increasingly difficult to afford them, according to a comprehensive study released today by the WHO Regional Office for Europe. The study illustrates the challenges for national health systems, with specific examples, and shows that few countries in the WHO European Region have mechanisms in place to evaluate the cost-effectiveness of new drugs; this hampers the value-assessment and decision-making processes.

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Cancer Innovation Coalition focuses on Precision Medicine Initiative

Wednesday, March 25, 2015 03:02 PM

The Cancer Innovation Coalition (CIC) has called on government leaders to put patients first when introducing new legislation and implementing President Obama's Precision Medicine Initiative.

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BRANY earns five-year AAHRPP accreditation

Wednesday, March 18, 2015 01:20 PM

BRANY has successfully continued its full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The five-year accreditation reflects BRANY’s continuing commitment to protecting the rights and welfare of research participants. AAHRPP’s accreditation process helps organizations consistently meet ethical principles and standards for protecting research participants.

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Study: How much should cancer drugs cost?

Monday, March 16, 2015 01:54 PM

The true cost of cancer drugs is 30% less than a decade ago, once longevity and quality of life are considered, according to a Cornell University researchers based on a study, A Quality-Adjusted Price Index for Colorectal Cancer Drugs, released by the National Bureau of Economic Research (NBER).

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Western Institutional Review Board receives ISO 9001:2008 certification

Monday, March 16, 2015 08:00 AM

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software, has announced Western Institutional Review Board (WIRB) has been certified to ISO 9001:2008 by BSI, confirming it operates an excellent quality management system.

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U.K. industry paid $456.7M in 2014 to underwrite medicines bill

Friday, March 13, 2015 12:28 PM

The Association of the British Pharmaceutical Industry (ABPI) and the U.K. Department of Health have announced a fourth quarter payment from industry of $119.3 million to underwrite the growth of the medicines bill under the 2014 Pharmaceutical Price Regulation Scheme (PPRS). This takes the total payment made by industry during 2014 to $456.7 million.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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