Study Conduct

NWBT expands clinical sites in ongoing brain cancer trial

Thursday, August 4, 2011 11:36 AM

Northwest Biotherapeutics has expanded its number of clinical trial sites, and now has 12 sites across the U.S. open and active, where patients can enroll in the ongoing clinical trial of DCVax immune therapy for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. The company also reported that a substantial number of additional sites are in progress. With the 12 sites already open and active, and others in progress, the company is on track to fulfill its prior projection that it will have 15 sites open and active in Q3 of this year.

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Comprehensive Clinical Development expands operations

Wednesday, August 3, 2011 11:35 AM

Comprehensive Clinical Development, a clinical services company delivering high-quality clinical trials from phase I-IV with three pharmacology units and five patient-focused centers,  has expanded  the company with the relocation of its corporate headquarters in Miramar, Florida.

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Cetero says FDA’s actions ‘difficult to understand’—company notified agency of chemists’ misconduct

Monday, August 1, 2011 08:02 AM

Large, early-phase CRO Cetero Research seemed blindsided by the FDA’s letter to the company last week accusing it of falsifying data and manipulating samples over a five-year period at its Houston bioanalytics lab.

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FDA inspections find Cetero faked records, manipulated samples

Wednesday, July 27, 2011 01:43 PM

Drug companies that had medicines tested by contractor Cetero Research might have to re-evaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples, according to Reuters.

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Government proposes rule changes on human research

Monday, July 25, 2011 01:58 PM

The government is proposing changes in the rules covering research involving human subjects, an effort officials say would strengthen protections while reducing red tape that can impede studies, according to The New York Times.

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Despite seeing benefits, industry awaits FDA final guidelines before adopting adaptive design trials

Monday, July 18, 2011 08:02 AM

The promise of adaptive design clinical trials exists, with increased ethical treatment of patients, greater likelihood of finding the optimal dose and shortened study duration. But a variety of sponsor and CRO barriers—lack of experienced personnel with the required skills and knowledge, misunderstood benefits and greater complexity of design and trial implementation—have slowed their widespread adoption.

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Vince & Associates opens neuropsychiatric research center

Thursday, July 14, 2011 12:21 PM

Vince & Associates Clinical Research, a provider of early development clinical trials, has opened the Neuropsychiatric Research Center in Overland Park, Kan.

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Study brokers Interspond, Elias Research head to court over alleged trade secret violations

Monday, July 11, 2011 08:02 AM

Two trial management firms (TMOs), known more commonly in the industry as study brokers, have taken their disagreement to court.

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Amgen, UCB experiment with NASA

Wednesday, July 6, 2011 01:17 PM

Amgen and UCB are collaborating with the National Aeronautics and Space Administration (NASA) to conduct a pre-clinical test of a sclerostin antibody in an experiment that will take place aboard space shuttle Atlantis on the final NASA shuttle mission, Space Shuttle Flight STS-135.

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Study raises concerns about orphan drug safety, citing fewer patients, lower standards in clinical trials

Tuesday, July 5, 2011 08:00 AM

Pivotal trials for orphan cancer drugs often have fewer patients and lower standards than trials for more prevalent cancers, raising concerns about the safety and efficacy of some drugs approved to treat rare medical conditions, according to a new study published in the Journal of the American Medical Association (JAMA).

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