If you are diagnosed with stage III colon cancer, you will probably receive about six months of treatment with FOLFOX after surgery. Research shows that this treatment regimen helps prevent recurrence for some – but not all – patients with stage III colon cancer.  A clinical trial has been launched to answer two questions about this current standard of care:

1. Will recurrence rates go down if both FOLFOX and celecoxib (a non-steroidal anti-inflammatory drug similar to aspirin) are used for treatment?

2.  Will recurrence rates stay the same and long term side effects decrease if FOLFOX is used for three months?

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By Nancy Roach, the Founder of C3 and Chair of its Board of Directors

On November 4, the National Cancer Institute (NCI) held the 9th meeting of the Clinical Trials and Translational Research Advisory Committee (CTAC). CTAC advises NCI on the implementation of the 2006 recommendations from Clinical Trials Working Group and the 2008 recommendations for the Translational Research Working Group. There’s more information about NCI’s initiatives here.

I am one of two advocates who serve on CTAC, and as an ex-systems analyst, I’m always looking for ways to make government more efficient and accountable.  At the November 4 meeting, recommendations were presented to increase the efficiency of the clinical trial development process – from the time that a researcher presents a concept to NCI to the time that the trial is actually activated.  Under the leadership of Dr. James Doroshow, NCI and its partners are taking aggressive steps to de-bureaucratize publicly-funded cancer research, which will ultimately benefit patients by putting resources into research instead of process.

Following is a very brief overview of the background and the recommendations, with links to additional documentation. And believe it or not, zombies did come up in the discussion!

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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 »

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

On September 14, I participated in the second Conference on Clinical Cancer Research, hosted by Friends of Cancer Research and the Engelberg Center for Health Reform at the Brookings Institute.  The 2008 conference identified specific areas of clinical research that could be “de-bureaucracied”.  In 2009, the conference presented the progress made in the past year, and identified next steps.

Following is background and a report on my panel’s discussion regarding centralized review of scans to determine progression free survival in phase 3 trials.

Warning: this meeting delved into highly technical aspects of clinical research, so the following is a little geeky!

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Oxford University

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

On September 5 -6, I put on my sensible black shoes to attend the second Sensible Guidelines for the Conduct of Clinical Trials meeting at Oxford University in England.  This invitation-only meeting convened research leaders to discuss how to improve large randomized clinical trials.

Why “Sensible Guidelines”?

People are the ‘experimental subjects’ of clinical research. Since World War II, laws and regulations have been passed to make sure that research participants are protected during the conduct of clinical trials. Over time – and especially in the last decade – many of the well-meaning laws and regulations have had an unintended consequence:  bureaucracy that does not always protect or help patients, but does eat up resources. Patients in trials often see only the tip of the bureaucratic iceberg, while research staff, academic institutions, government agencies and drug companies struggle with the rest of it.

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