Tuesday, September 30, 2008

Find Drugs that Work for Cancer

by Cecilia O. Arradaza, Communications Director, FasterCures
To win the war on cancer, our nation’s decision-makers need to enact policies that support cutting-edge developments in cancer research and facilitate patient-centered approaches throughout the research continuum. This message permeated through discussions at Friday’s Clinical Research Conference convened to address pressing scientific and regulatory challenges and opportunities for progress in innovations in cancer therapy. The conference was organized by Brookings Institute, Friends of Cancer Research, American Society of Clinical Oncology, and American Association of Cancer Research.

More than a hundred leaders in cancer research and advocacy representing academia, government, industry, and the nonprofit sectors convened for a full day discussion of scientific and policy issues impacting clinical cancer research. The diversity of viewpoints and the depth of commitment to furthering cancer research spurred an engaged discussion among participants anxious to address our nation’s cancer challenges.

NCI Director John Niederhuber said in his opening remarks, that the 21st century paradigm will be anchored on translational science and based on multiple, highly-targeted agents matched to molecularly selected patients. Important issues were raised by panels that followed and some key recommendations rose to the top. Highlights include:
  • The first panel looked into data standards and evidence requirements and noted that “it’s easy to get data…the challenge is to ensure the data we have is any good.” To make sure new drugs are safe and effective with the optimal amount of information, the panel recommended the development of qualitative and quantitative standards for data collection to streamline the path to more efficient clinical trials.
  • Measuring treatment efficacy is a complex and subjective process and the oncology community has long sought endpoints other than overall survival. Looking for a better way of measuring the effectiveness of new drugs and accelerating safe and effective cancer drug development, the second panel proposed three different scenarios that look into progression-free survival as an indicator of clinical benefit.
  • The promise of personalized cancer therapy remains largely unfulfilled and there have been few successful efforts to develop therapies and their targets simultaneously. The third panel recommended the following:
    - External stakeholders should be engaged in the design of a pathway for the development of diagnostics for tumor markers.
    - Tumor-marker clearance and approval should be based on demonstrated clinical benefit.
    - An advisory committee similar to the FDA’s Oncologic Drugs Advisory Committee should be developed for tumor marker clearance and approval in order to improve consistency and coordination with other oncology programs in the agency.
  • The final panel painted a vision for the FDA’s future. FOCR’s Ellen Sigal noted that complex science is at the base of all the discussions and that the process for defining a clear path forward is always evolving, making it critical to garner the input of diverse stakeholders every step of the way.
At day’s end, having mined the combined braintrust of panelists and participants, former FDA Commissioner David Kessler articulated a key action step and perhaps a challenge for the next person to lead the FDA. Kessler said we “need an FDA Commissioner who will say: find drugs that work for cancer.” Someone who is willing to take risks, make mistakes but who has a clear idea of what they want and be able to articulate this amidst competing priorities. On this note, be on the lookout for FasterCures’ upcoming recommendations for the new administration regarding the FDA.

1 comment:

Margo Michaels said...

Surprisingly, the meeting described above did not adequately address the nation’s continuing poor performance in cancer clinical trial participation, particularly among racial and ethnic minorities and low income groups. According to a new national report, addressing this problem will require meaningful public involvement in the design and implementation of clinical trials. Despite many previous calls for community participation and engagement, this report is the first to define how the cancer clinical trial system can involve communities affected by cancer: from trial design - to implementation - to dissemination of research results.
The "Communities as Partners in Cancer Clinical Trials project," convened by the Education Network for Advancing Cancer Clinical Trials (ENACCT) and Community-Campus Partnerships for Health (CCPH), is funded by a core grant from the Agency for Health Care Research and Quality (AHRQ) and the National Cancer Institute. Read more at www.communitiesaspartners.org