Strange new legislation and corruption in clinical trials – June 16, 2009
This is my site Written by Alex on June 16, 2009 – 9:51 am   

A new piece of legislation in the U.S. House aims to increase clinical trials participation by allowing patients with rare diseases to become subjects in trials and not lose their government health insurance. The move is applauded by the Cystic Fibrosis Foundation as a new way to get medications from the research stage into the “hands of people who need them.” This is worth watching long term to see what the implications of this kind of fast-tracking is for drug development and for subjects and patients…. also, the FDA is putting tighter warnings on some asthma drugs because test facilities where some went through trials were not at all to up to par… All this plus industry news is in today’s update which you can read below…

New Legislation Seeks to Boost Participation in Clinical Trials … PR Newswire (press release) – New York, NY, USA – The “Improve Access to Clinical Trials Act” is co-sponsored by Representatives Edward J. Markey (D-MA) and Cliff Stearns (R-FL) and 30 members of the House … See all stories on this topic

FDA Move on Asthma Drug Warnings Comes After Complaints About … BNET – San Francisco, Ca, USA – The brazen “study buddy” and “crossover” arrangements, as staff referred to them, included churning or serially enrolling patients into clinical trials … See all stories on this topic

MarketWatch – USA – “In the past 30 months, we have conducted 14 clinical trials with the three product candidates that were licensed into Symphony Allegro…See all stories on this topic

Helix BioPharma Announces Q3 2009 Financial Results and Provides … MarketWatch –USA – The new expected timing of filing the confirmatory European Phase III Clinical Trial Application has not yet been established … See all stories on this topic

ERT to Showcase Its Clinical Trials Portfolio at DIA’s 45th Annual … MarketWatch – USA – The presentation entitled “Addressing Suicidality in Clinical Trials” will be chaired by John H. Greist, MD of HTS Inc and will discuss FDA safety concerns … See all stories on this topic

Clinical Trials Update: June 15, 2009U.S. News & World Report – Washington, DC, USA – If you are a current or former smoker, at least 40 years old, and have been diagnosed with COPD, you may qualify for this study. If you are age 16 or older … See all stories on this topic

Prostate Cancer Active Surveillance Protocol Clinical Trial … PR Web (press release) – Ferndale, WA, USA – NorthShore University HealthSystem (NorthShore) is conducting the only prostate cancer active surveillance clinical trial in the Chicago area and one of … See all stories on this topic

DZS Software Solutions to Preview clinplus® Clinical Trial … (press release) – Levittown, NY, USA – clinplus® expands their existing suite of clinical trial software and service solutions to include web-based Clinical Trial Management System (CTMS) … See all stories on this topic

EULAR: Good Efficacy Seen in RA for IL-6 InhibitorMedPage Today – Little Falls, NJ, USA – Explain that the drug is not FDA-approved and is currently available only in a clinical trial setting. Note that this study was published as an abstract and … See all stories on this topic


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