During the Oncology Nursing Societys
(ONS) Eighth Annual Fall Institute Meeting, oncology nurses discussed
guidelines for implementing clinical trials within office-based
Patricia Paquette, RN, and clinical nurse manager at Oncology
Consultants in Houston, Texas, explained that clinical research has
moved from institution- to office-based settings in an effort to
reduce costs by accruing patients from their geographic area and
allowing trial sponsors to tap into a much larger potential pool of
Sponsors of clinical trials have traditionally been focused through
the cooperative research study groups of the National Cancer
Institute (NCI) and designated facilities. However, the changing
complexion of health care and the proportionately low number of
patients treated in these facilities are fueling efforts to increase
access to care and clinical trials, meet restrictions of managed care
payors, and comply with the demands of more educated consumers.
Collaborative groups of researchers, including basic scientists,
physicians, nurses, and the health care pharmaceutical and biomedical
industry, have evolved across the nation to bring research benefits
to the community-based practice. In addition, many research
institutions and agencies are looking into this issue in an attempt
to develop community networks to provide opportunities for
Pharmaceutical companies outside of the auspices of the NCI and other
cancer centers subsidize much of the drug testing conducted in
community-based clinical trials. It is the support of industry-sponsored
participating institutions that has fostered the growth of
office-based trials, and community offices have provided care for
most cancer patients throughout the past decade.
Nursing research in office-based practices is difficult to fund
because it cannot be billed to third-party payors as a separate
entity within the patients care system. Three kinds of costs
are involved in clinical research. The first two, administrative and
data management costs, as well as the specific costs of drugs or
procedures specifically defined by the study protocol, are unique to
patients entering clinical trials and are usually supported by the
studys sponsor. The third type of cost, namely, the cost of
overall care of the patientwhether under standard or research
agent carehas become the most troubling issue in clinical
research and office practice.
The complexity of oncologic care has increased dramatically as it
continues to shift into the private or community practice arena. New
treatments can increase survival but only when patients have access
to a full range of support services needed to complete treatment and
achieve maximum benefits. This, in turn, requires detailed case
Kay Aron, a clinical services coordinator for Oncology Hematology
Associates of Kansas City who developed a clinical research program
for her office, explained the endless cycle this quandary presents.
Patients need better, more effective forms of therapy, she said, but
payors require demonstrated efficacy before theyll approve and
reimburse for a drug treatment. Proving that efficacy, however, means
conducting clinical trials, but clinicians cant enroll the
patient in clinical trials because the payor wont cover it.
Related medical costs for that patients care may also be
denied, and, therefore, part of the challenge facing clinical
research nurses is finding alternative funding sources.
Although there have been some signs of progress, Ms. Paquette stated
that the future of clinical trials is at risk unless there is reform
in insurance reimbursement. As cost-benefit data and patient outcomes
are analyzed, strong support for the value of clinical research
becomes critically important. She urged collaborative efforts between
research cooperatives, the NCI, the pharmaceutical industry, special
oncology associations, and patient advocacy groups to unite in the
war against cancer and resolve conflicts between health-care
providers and payors.
Cancer Panel Recommendations
Findings in the presidents 1996 cancer panel echoed concerns
about research and cancer care, stating that short-term,
short-sighted cost containment can and will impede the progress of
the national cancer plan. The panels report strengthened the
ONS position that complex approval processes and exclusionary
policies on the part of the insurance industry greatly limit
patients access to care and discourage the medical
establishment from pursuing important clinical goals.
Other panel recommendations are that clinical trials become formally
incorporated into both standard oncology patient care and clinical
guidelines for treating specific malignancies; that research costs be
fully covered so that quality of health care can continue to rise;
that all beneficiaries of health care share in the cost of that care,
including managed care payors and research sponsorsboth private
and federal, volunteer agencies, pharmaceutical and biotechnology
industries, and employers and employees; that partnerships among
industry, public, and private research groups are fostered to ensure
that important issues in clinical research are addressed; and that
the insurance appeals process be simplified, standardized, and, most
importantly, fully disclosed to participants. The ONS position paper
on the quality of cancer care states unequivocally that an individual
with cancer must has have access to participation in sound scientific
How to Implement Clinical Research
For any community-based practice intending to pursue clinical
research, Ms. Aron strongly recommended forming a research team,
starting with the patient and including the physician(s) and a
principal investigator who is thoroughly educated in the protocol and
its related administrative matters; a research coordinator with the
time and opportunity to obtain data as needed; clinical nurses who
will see the patient and deliver care; general health care personnel
for the pharmacy and laboratory; and administrative staff for medical
record-keeping, budgeting, data management, and meeting what she
warns are unbelievable regulatory requirements.
Office-Based Clinical Research in a Nutshell
An oncologist who have the potential to enroll > 100 patients per
year in clinical trials and can deliver a predictable accrual
Enthusiastic physician support of the clinical initiative
Clinicians with access to promising drugs not yet approved bythe FDA
Innovative trials that answer important clinical questions
A sufficient number of trials available through contacts with the
An effective research staff
Trials that fill clinical needs and have scientific merit
Criteria for Establishing Scientific Merit:
What is being studied?
Are the objectives clearly defined?
Are the objectives as measurable as possible?
Are there enough patients in the study to give it statistical power?
Do the planned assessments permit valid conclusions?
Is the study designed appropriately for the proposed subjects?
Does the study incorporate reasonable precautions to eliminate bias?
Are the control groups appropriate?
What is the degree of physician and nursing interest in the trial?
Will the study sponsor be willing to modify the trial if portions
What academic reputation can be gained by this participation?
What provisions are made in the contract regarding publication rights?
Questions to Ask to Ensure That a Proposed Trial Meets Ethical Guidelines:
What are the risks to patients?
Is the product safe and effective?
Are there any issues, such as the use of placebos, that might
ffect institutional review board approval?
Are qualified staff members available to conduct the trial?
Can patient enrollment be achieved in the projected time period?
Are federal protocols included or excluded in the study?
Is the principal investigator fully committed in terms of time?
Is the research laboratory personnel fully involved?
Is there enough space (new furniture, personnel) and equipment
Are safety issues covered?
Are measures in place to handle emergencies, such as adverse drug reactions?
She also suggested setting up a research committee composed of
physicians, nurses, and laboratory or pharmacy technicians who will
evaluate new protocols for the feasibility of bringing them into the practice.
Ms. Aron stressed that educating the physicians and forming a
business relationship with them is key to a smooth-functioning
practice. Unless the physicians involved in the protocol thoroughly
understand its content, its specifics, and all of the administrative
duties associated with completing a trial, control of the project
(and thus its credibility) may be compromised.
She also cautioned clinicians not to overlook practical issues that
must be addressed, such as space requirements for new personnel and
furniture, the need for additional equipment (eg, copiers or fax
machines), and ample allowance for the increasing amounts of time
required to keep current records and reports.