Study Conduct

NIHR launches new Clinical Trials Toolkit for researchers

Thursday, January 10, 2013 02:09 PM

The National Institute for Health Research (NIHR) has launched a new Clinical Trials (CT) Toolkit web site designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements.

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Mystery shopper campaign highlights NHS shortcomings in promoting clinical research

Thursday, January 10, 2013 02:05 PM

Many British NHS patients are hitting an information "brick wall" when it comes to finding out about clinical research, according to the results of a mystery shopper investigation commissioned by the National Institute for Health Research Clinical Research Network.

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Biogen Idec to discontinue development of ALS drug

Friday, January 4, 2013 10:29 AM

Weston, Mass.-based Biogen Idec has decided to discontinue development of dexpramipexole in amyotrophic lateral sclerosis (ALS), after top-line results of EMPOWER, its phase III trial, did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival.

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FDA clears IND for first study protocol developed using crowdsourcing

Tuesday, December 18, 2012 12:02 PM

The FDA has cleared the Investigational New Drug Application (IND) for lisinopril to be assessed as an adjunctive therapy for multiple sclerosis (MS), according to Transparency Life Sciences (TLS), a drug development company based on open innovation.

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UAB to enroll patients in pilot study using Mytrus’ iPad app

Tuesday, December 18, 2012 11:08 AM

The University of Alabama at Birmingham (UAB) will use an iPad application developed by Mytrus, a clinical technology and services company for medical and pharmaceutical research, in an upcoming pilot study supported by the U.S. Department of Health & Human Services Agency for Healthcare Research and Quality.  

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Prize4Life launches PRO-ACT, largest ALS trials database ever created

Friday, December 7, 2012 10:42 AM

Prize4Life, a nonprofit organization dedicated to accelerating discovery of treatments and a cure for ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease), launched the PRO-ACT (Pooled Resource Open-Access ALS Clinical Trials) database, the largest ALS clinical trial database ever created.

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PharmaVigilant releases I-Accountability to enhance traceability of drug inventory

Friday, December 7, 2012 02:33 AM

PharmaVigilant, a software developer based in Westborough, Mass., has released I-Accountability, a drug accountability system that efficiently tracks and controls drug inventory and randomization.

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OHE releases new study on pharmaceutical R&D costs

Monday, December 3, 2012 01:33 PM

The Office of Health Economics has released a comprehensive study of the cost of R&D for new medicines. It reviews research published over the last three decades, which shows an increase in costs from $199 million per new medicine in the 1970s to $1.9 billion in the 2000s. An OHE costs analysis based on new data for 1998-2002 agrees with comparable analyses for the same time period.

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CRA enters strategic alliance with Quintiles

Tuesday, November 27, 2012 11:42 AM

Tempe, Ariz.-based Clinical Research Advantage (CRA), a community-based network of clinical trial sites, has entered into a strategic agreement  with CRO Quintiles to facilitate a higher level of clinical trial participation with an emphasis on safety, improved study efficiencies and quality data.

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QPS expands phase I clinic in the Netherlands

Tuesday, November 27, 2012 11:31 AM

QPS Holdings has completed a 24-bed annex to its phase I clinic at the University Medical Center Groningen in the Netherlands, bringing to 58 its bed capacity for the conduct of first-in-man and early-phase research on novel and complex therapeutic agents.

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