Cystic fibrosis and a bill to fast track trials could present problems – June 26, 2009
This is my site Written by Alex on June 26, 2009 – 10:05 am   

Legislation making it easier for people with rare diseases to enroll in clinical trials – chiefly by removing restrictions to government health benefits such as SSI if they do so – is making its way through Congress. The bill, called 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 of Representatives. The bill is specifically aimed at boosting enrollment in trials testing new treatments for cystic fibrosis, a condition that affects 30,000 people in the U.S. The long term effects of actual legislation to increase enrollment in trials are unknown. It might be, and I have a feeling it will be, the start of slippery slope that makes enrollment of ever more subjects in trials an easier and less regulated process. Fast tracking trials  is risky. Having the government endorse such practices could prove disastrous. I hope I’m wrong and we’ll keep an eye on how this proceeds in the coming weeks and months…  

Children’s in cystic fibrosis trial test – Bizjournals.com – Charlotte, NC, USA – Vertex will conduct three different clinical trials as part of the registration program for the drug involving approximately 110 sites … See all stories on this topic

US HOT STOCKS: Palm, Standard Micro Active In Late TradingWall Street Journal – USA – Jazz Pharmaceuticals Inc. (JAZZ, $4.48, +$1.23, +37.85%) said preliminary results from a second Phase III clinical trial of its fibromyalgia treatment … See all stories on this topic

Buffalo is First Site in US to Initiate Clinical Trial of … UB News Center – Buffalo, NY, USA – The company will be conducting three different VX-770 clinical trials as part of a registration program for VX-770, involving a total of approximately 110 … See all stories on this topic

OraSure says new trials of hepatitis test neededForbes – NY, USA – OraSure Technologies Inc. said Thursday the regulators want it to run new clinical trials of its OraQuick hepatitis C test, and added it has had problems … See all stories on this topic

CNS Closes $1M Bridge Loan, Completes Clinical Trial EnrollmentOneMedPlace – New York, NY, USA – The company has completed enrollment at 14 sites for a treatment-resistant depression clinical trial. CNS Response is now on track to complete the study by … See all stories on this topic

Medtronic to carry out two clinical trials on stroke interventionTrading Markets (press release) – Los Angeles, CA, USA … of medical technology, announced on Wednesday that it is to carry out two worldwide clinical trials to study medical device interventions for stroke … See all stories on this topic

Medidata Stock Up in IPOHealth Data Management – Chicago, IL, USA – The stock price of clinical trials software vendor Medidata Solutions Inc. rose more than 28% at the open of trading today following an initial public … See all stories on this topic

Jazz Pharmaceuticals (JAZZ) NewsBite – JAZZ Rises on Clinical … Market Intelligence Center – Charlottesville, VA, USA – Shares of JAZZ are trading higher on news that the second of two Phase III clinical trials of sodium oxybate for the treatment of fibromyalgia met its … See all stories on this topic

 

Leave a Reply

You must be logged in to post a comment.