Journal of the American Medical Association

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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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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