Sorry but today I am also getting into new and very difficult data to discuss but wanted to give it a shot since you may surf the Net and come across data which are shown to be negative leading to some stress if you are on similar or same therapy.

I attended the European Meeting for Medical Oncology in Berlin two weeks ago, and some new data were presented. Let’s start with the good news which is consistent with all the data we have. In a large randomized phase III trial called CRYSTAL comparing FOLFIRI with or without Erbitux® (cetuximab), the data showed that in patients with wild-type KRAS response rate went up to 60% and time to tumor progression increased about 30% but, so far no overall survival benefit was shown.  The trial was criticized for that. Read the rest of this entry »

In response to a request from the Centers for Disease Control, the Food and Drug Administration will allow emergency use of the investigational antiviral intravenous drug peramivir in some hospitalized patients with 2009 H1N1 influenza infection.  The Emergency Use Authorization (EUA) is effective for both adults and children from birth to age 17.

There are currently no intravenous (IV) antiviral medicines approved for influenza.  Read the rest of this entry »

Briefly: Health care providers are less likely to recommend colorectal cancer screening to their patients with a high school education or less.  IV ibuprofen enhances morphine to control post-operative pain, reducing pain and letting patients use less morphine.

Superspreaders with dirty hands infect large numbers of patients with hospital-borne infections.

The United Ostomy Associations of America has a new video for new and potential ostomates that provides encouragement and support, and CR Magazine’s monthly podcast provides help coping with medical testing stress. Read the rest of this entry »

With the increasing expense of treating colorectal cancer, treatment cost savings in the near future will more than double when screening prevents colon and rectal cancers or finds them early.

Looking at expense for an entire population, all screening methods except colonoscopy cost less than treating those cancers that developed, and the net cost of colonoscopy screening fell from over $1,300 to less than $300 per individual in the population. Read the rest of this entry »

Nancy Roach is the Founder of C3 and Chair of the Board of Directors.

On September 22, I participated in a meeting that looked at some of the profound implications of the growing amount of publicly-available data, and grappled with questions around reporting research results using this data.  The day’s agenda was titled “Interpreting and Communicating Clinical Data in the Public Domain,” and the meeting was convened by the FDA Clinical Trials Transformation Initiative (CTTI).

The meeting delved into a lot of detail:

• Legislation which requires research sponsors to make summary data publicly available in www.clinicaltrials.gov, both positive and negative results;
• Existing guidelines and best practices for both clinical trials and meta-analyses; and
• Existing efforts to clarify guidelines for meta-analyses.

At the end of the day, my personal conclusion was that meta-analyses will be used in the future to make health care recommendations, and that strong guidelines are critical.  The meeting results are still being processed, so no formal recommendations have occurred yet. Read the rest of this entry »