ONS Guidelines on Office-Based Clinical Trials

During the Oncology Nursing Society’s (ONS) Eighth Annual Fall Institute Meeting, oncology nurses discussed guidelines for implementing clinical trials within office-based community practices.

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 patients.

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 office-based practices.

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.

Funding Sources

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 patient’s 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 study’s sponsor. The third type of cost, namely, the cost of overall care of the patient—whether under standard or research agent care—has 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 management efforts.

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 they’ll approve and reimburse for a drug treatment. Proving that efficacy, however, means conducting clinical trials, but clinicians can’t enroll the patient in clinical trials because the payor won’t cover it. Related medical costs for that patient’s 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 president’s 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 panel’s 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 sponsors—both 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 clinical trials.

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

Basic Requirements:

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 pharmaceutical industry

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 require changes?

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 copier, refrigerator to hold specimens) to handle new procedures?

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.