Bureaucracy-busting & Getting Rid of the Zombies

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!

Continue reading…

Posted by Nancy Roach on November 20th, 2009
Posted in: Research & Treatment News | No Comments »

Setting Standards for Meta-Analyses

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. Continue reading…

Posted by Nancy Roach on October 21st, 2009
Posted in: Policy & Advocacy News, Research & Treatment News | No Comments »

Conference on Clinical Cancer Research: Meeting Report

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!

Continue reading…

Posted by Nancy Roach on October 7th, 2009
Posted in: C3 News, Research & Treatment News | No Comments »

Oxford Conference Looks at Sensible Approach to Clinical Trials

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.

Continue reading…

Posted by Nancy Roach on September 17th, 2009
Posted in: C3 News, Research & Treatment News | No Comments »
Tags: clinical trials

C3 Submits Comment on ESAs to FDA Advisory Committee

By Nancy Roach, Chair, C3 Board of Directors

C3 has submitted comment to the Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC), recommending that FDA implement a Special Restriction Distribution Program for Erythropoiesis Stimulating Agents (ESAs), to maximize patient safety and ensure the rapid collection of patient information.

ESAs, better known under brand names, Procrit, Epogen and Aranesp, were approved by the Food and Drug Administration (FDA) to reduce the need for blood transfusions and have been used widely to aid with chemotherapy-induced anemia. Research results have indicated that higher doses of ESAs could actually cause a patient’s cancer to grow faster, and increase mortality, pointing out the need for future research to nail down the risk/benefit ratio of ESA use.

C3, in partnership with other advocacy organizations, has been working with FDA and ESA manufacturers (Amgen and Johnson & Johnson) to ensure that patients are helped, not harmed, by these supportive care drugs.

ODAC will be meeting on March 13, 2008 to discuss new research findings, future research plans and the current clinical situation. Carlea Bauman, C3 President, will speak during the open public hearing. In addition, C3 has submitted comments identifying questions such as:

• What is the plan for answering the question of whether ESAs have a tumor-promoting effect?
• What is the plan for answering the question of whether ESAs provide patient benefit when dosed according to the FDA label?
• What is the appropriate clinical use of ESAs pending the answers to these questions?

Ultimately, C3 recommends that ESA use be closely monitored, similar to the way that thalidomide use is monitored.

For additional information, see:

• www.ESAFacts.org presented by the Marti Nelson Cancer Foundation
• Briefing information from the May 10, 2007 ODAC meeting

Disclosure: C3 believes in fully disclosing sources of financial support, per our disclosure policy which can be viewed here. In 2006 and 2007, C3 received funding from Amgen in the form of a charitable donation. Since the May 2007 Oncology Drug Advisory Committee (ODAC) meeting, C3 has met with Amgen and Johnson & Johnson (J&J) to increase our understanding of these issues and express our concerns. J&J held a meeting on February 19, 2008 in Washington, DC, and paid the travel expenses of a C3 Board member so that she could attend the meeting.

Posted by Nancy Roach on March 1st, 2008
Posted in: Research & Treatment News | No Comments »