Clinical Trial Design, Drug Development, and Policy Issues of Importance to Cancer Advocates

Transcription

1 Clinical Trial Design, Drug Development, and Policy Issues of Importance to Cancer Advocates Ellen L. Stovall National Coalition for Cancer Survivorship (NCCS) Institute of Medicine Workshop October 5, 2007

2 Patient Advocates and Clinical Research n Views about patient participation in clinical research are not universal n Clinical trial design is one factor but remains an unproven barrier n Many studies have been done to assess physician and patient attitudes to clinical trial participation

3 Physician & Patient Attitudes toward Clinical Trials n Lack of physician and patient awareness of open clinical trials and the unavailability of protocols to both the patient and physician at the time of consultation [Metz, et.al. 2005] n Lack of participation can be categorized generally as an absence of knowledge about clinical trials; unwillingness to be randomized; time constraints; distance from treatment center; insurance denial; and distrust of the medical establishment [Metz, et.al. 2005]

4 Attitudes of Advocates & the Public Toward Drug Development n The Unrealized Promise of Biotechnology l l l Gleevec example raised hope, but has not been easily replicated. Even successful follow-on drugs like Herceptin Tarceva, and Avastin are limited in their impact on patients. Cancer is typical example of personalized medicine high drug prices and high co-pays & present access challenges to patients who could benefit from them

5 Unrealized Promise of Biotechnology n The way our country has funded and conducted research is being challenged i.e. ongoing debate over NIH reorganization and importance of clinical trial participation (e.g., CMS/NCD reconsideration n Everyone government, academia, industry must recognize that our efforts have fallen short of what was promised to taxpayers and patients.

6 Threats to Future Progress: Excessive Avoidance of Risk n People with life-threatening diseases like cancer are less likely to be concerned about newly discovered safety issues than patients who take drugs for other conditions n No medical intervention is entirely free from risk, and pharmaceutical innovation may be deterred if decision makers focus too much on risk avoidance.

7 Threats to Future Progress: Discrepancy in How Advocates View Access to New Therapies n NCCS has always advocated maximum access for people with cancer, and believe that access to new therapies should be based on sound and reliable medical evidence. n Access issues differ among advocacy groups, e.g., Abigail Alliance/Washington Legal Foundation call for individual access to unapproved therapies by those who can pay for them as a Constitutional right.

8 Regulatory & Financing Issues n complexities which include past and current Medicare clinical trials coverage decisions; n the adherence to standards for granting accelerated approval; n the status of FDA s issuance of final guidance on expanded access programs n oversight regarding compliance with FDA policies regarding review of new cancer indications by the Oncologic Drugs Advisory Committee.

9 Potential Remedies n Prioritize and expand access to research protocols that transcend individual interests for the common good n Create an incentives and rewards-based practice environment for individual physicians to engage in clinical research n Advocates should work with FDA & clinical trials sponsors on their drug development programs and clinical trial designs to allow for expanded access to innovative cancer treatments

10 Potential Remedies n Developing a public policy approach that takes a longer view and is not swayed first to one extreme and then another by sensationalist media or political coverage n Forging new partnerships among government, academia, industry, providers and patients, based on more open sharing of information and honest assessment of relative strengths and weaknesses of various ongoing initiatives.