Ethics/Regulatory

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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Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Monday, March 23, 2015 08:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

Responding to industry concerns about the use of electronic Informed Consent (eIC) in regulated clinical trials, the FDA has issued a draft guidance that opens the door to the use of podcasts, “biological recognition devices” and other electronic media to improve understanding of trial participation.

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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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First U.S. biosimilar approval opens floodgates for lower-priced competition to blockbuster biologics

Monday, March 16, 2015 08:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

The FDA’s approval this month of the first U.S biosimilar, Zarxio from Sandoz, has formally opened the floodgates for sponsors seeking approval of lower-cost biologics to compete with expensive brand-name prescription drugs.

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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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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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