| HOME | HELP | CONTACT US | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
NEWS AND SPECIAL REPORT |
Pharmacia Corporation Marguerite.D.Baxter{at}pharmacia.com
CLINICAL RESEARCH
Numerous initiatives are under way by advocates, policymakers, and business leaders to address the evolving issues relative to clinical research. The cornerstone of our national capacity to sustain and expedite innovation and bring cures and effective therapies to individuals diagnosed with cancer, clinical research presents us with unique promise and challenges as we enter the age of molecule medicine. What follows is a summary of key initiatives under way which have the potential to impact clinical research and cancer care delivery over the next year.
Cancer Clinical Trials Summit
A unique process for follow-up from the Cancer Clinical Trials Summit V (summarized in [1]) has been launched by the Summit's conveners. In order to translate information sharing into action, six workgroups have been established for the Clinical Trials Summit participants to turn ideas into initiatives. This step was taken in order to enable the Summit to maintain momentum, allow participants to remain actively engaged in the objectives and outcomes of the Summit, increase accountability for progress, and assist in evolving the Summit series into an effective agent of change. The six workgroups that have been established will be working over the next 10 months on numerous initiatives including:
This process will include over 150 participants whose work will be undertaken in a series of quarterly conference calls. Summit VI, which will be held in the Fall 2002, will be the forum for updating the clinical trials community on the progress to date. These efforts will be fundamental in shaping the next steps in what has emerged as a problem-solving, action-oriented process to address the gaps and barriers to supporting an effective and efficient clinical trials system.
Corporate CEO's Commit to a Gold Standard for Cancer Clinical Trials
The National Dialogue on Cancer CEO Roundtable held its second meeting in Houston, Texas, on November 15-16, 2001. The CEO Roundtable, hosted by the M. D. Anderson Cancer Center, provided an opportunity for former President George W. Bush to participate in discussions with the CEOs about global and domestic challenges which impact our ability to bring effective cancer therapies from the bench to the bedside. Over 20 CEOs have participated in the CEO Roundtable initiative, including many from the pharmaceutical sector. Data demonstrate that corporations throughout the world are dramatically impacted by cancer, as it is the leading cause of death in people aged 35-65, the largest segment of corporate employees. During the Roundtable meeting the CEOs committed to developing an initiative to provide for their employees the coverage for patient-care costs associated with clinical trials that has been extended to Medicare beneficiaries through the Medicare National Coverage Decision. This will enable participating CEOs to set a gold standard of clinical trials reimbursement and coverage for their "corporate family" and provide a model for the larger business community. Follow-up plans for implementing this initiative will be considered at the 2002 Spring meeting.
Financial Conflict of Interests in Clinical Research
The General Accounting Office (GAO) recently released a report entitled "Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest." The report was requested by Senator William Frist (R-TN) to examine compliance of academic institutions with current Department of Health and Human Services (DHHS) regulations governing institutional and individual financial conflicts of interest. The report concluded that current regulations governing biomedical research, including Food and Drug Administration and Public Health Service regulations, do not go far enough in protecting human research subjects. The report further indicates that the DHHS needs to undertake initiatives to identify and manage investigator and institutional financial conflicts of interest and specifically recommended that the DHHS develop guidance or regulation in this regard. While GAO found that research universities and institutions had conflict of interest standards in place, they varied greatly from institution to institution, data collection was not similar, and standards did not necessarily apply to the institution's financial conflict but the investigator's conflict.
National Institutes of Health Addresses Clinical Cancer Research
The National Institutes of Health has charted a Study Section on clinical research. The Clinical Oncology Study Section, previously a special emphasis review panel, will review clinical trials and patient-oriented research applications. Their mandate includes all phase I, II, and III clinical trials using drugs, radiopharmaceuticals, radiation, and biological agents.
HUMAN REPRODUCTIVE CLONING
On January 18, 2001, the National Academy of Sciences issued a report that recommended that a legally enforceable ban on human reproductive cloning aimed at creating a child should be created. The recommendation is not based upon whether or not it is appropriate for society, but rather that human reproductive cloning is not safe for the embryo or mother and would likely be a failure. The report calls for a legally enforceable ban that carries substantial penalties for both the public and private sectors. The panel further indicated that such a ban should not be extended to research utilizing nuclear transplantation for research purposes due to the tremendous potential for developing medical advances from this form of research. Further, the panel called for a broader national dialogue on the ethical and societal issues related to nuclear transplantation for research purposes.
REGULATORY REFORM IS LAUNCHED BY THEBUSH ADMINISTRATION
On December 26, 2001 the Bush Administration announced the establishment of the Secretary's Advisory Committee on Regulatory Reform. The panel includes consumers and health professionals and is chartered to guide the DHHS effort to streamline unnecessary, burdensome and inefficient regulations that detrimentally impact the quality of health care for Americans. The Committee is expected to hold field hearings across the country. The input from these hearings will be used by the Committee to develop recommendations to both change current regulatory requirements and when appropriate address broader reforms.
To aid in defining the agenda for this Committee the DHHS published a notice in the Federal Register requesting input on the identification of specific DHHS regulations and requirements that serve as impediments in delivering health care and services to patients. Further, individuals will be invited to provide suggestions with regard to improving them. The Committee will then take these comments into consideration as it shapes its field hearings and identifies priorities for consideration. The Committee will make recommendations in four broad areas: health care delivery, health systems operations, the development of pharmaceuticals and other products, and biomedical and health services research.
OUTPATIENT PROSPECTIVE PAYMENT SYSTEM DELAYED UNTIL SPRING
As reported in the last update, there were a number of concerns regarding the timetable for the implementation of the 2002 Medicare outpatient prospective payment system (OPPS) final rule. On December 19, 2001 the Administration announced that the implementation of the OPPS would be pushed back several months, and it is anticipated that the implementation date will likely be April 1, 2002. The impact of the delay is estimated to be about $240 million for hospitals. The current payment rates will be in effect for the first three months of 2002 so as to address "technical miscalculations" in payment rates that were issued in November 2001.
|
REFERENCE
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | CONTACT US | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| THE ONCOLOGIST | STEM CELLS | CME | ALPHAMED PRESS JOURNALS |
