Study Conduct

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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National Parkinson Foundation awards more than $1 million for research

Thursday, June 30, 2011 01:06 PM

The National Parkinson Foundation (NPF) has awarded more than $1 million for clinical research projects. Through NPF's individual investigators awards program, it is supporting work to advance three key areas of Parkinson's disease: an advanced biomarker study, a clinical trial to treat memory impairment and a study of the effectiveness of a treatment for sleep apnea.

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Indian regulators suspend operations at CRO Axis Clinicals

Tuesday, June 28, 2011 02:30 PM

India’s Drug Controller General (DGCI) has suspended operations at Hyderabad, India-based CRO Axis Clinicals and is vetting all bioavailability and bioequivalence study centers in Andhra Pradesh state after investigations revealed irregularities in a trial conducted by Axis, reported PharmaTimes.

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Health Decisions creates ‘fixed-price trial’ model to incentivize CRO performance and speed timelines

Monday, June 27, 2011 08:03 AM

Since CROs began conducting trials for drug sponsors, there has been a lot of quibbling about cost. CROs claim to do the work more quickly, efficiently and inexpensively. But many sponsors have had the opposite experience, saying CROs don’t accomplish recruitment goals and keep extending the trial timelines to do so, adding to the sponsor’s costs. Some claim not all of the data is collected properly, taking months to then clean the data, for which sponsors are charged.

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