Chicago, IL—Taking part in clinical research poses administrative, logistic, and financial challenges to community oncology practices, but also presents these organizations with opportunities for a more active role in shaping patient care. Therefore, community practices that venture into clinical research should strive to follow emerging guidelines aimed at establishing exemplary clinical trial sites, according to speakers at an American Society of Clinical Oncology (ASCO) education program.
Considerations involved in developing an exemplary research site include the following:
Clinicians in community oncology practices care for 85% of oncology patients, and 50% to 60% of patient accrual in clinical trials comes from the community setting; however, less than 20% of oncologists and 2% to 7% of all patients with cancer participate in clinical trials.
The Ingredients for Success
Successful clinical research sites have several common traits, which Dr Zon highlighted. They include:
These principles are outlined in ASCO’s statement on minimum standards for exemplary clinical trial sites, which Dr Zon helped to write.1
First and foremost, exemplary clinical trial sites adhere to the clinical practice guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Dr Zon said. Adherence to the guidelines is a requirement for participation in federally funded and industry-sponsored clinical research.
The National Academy of Sciences Institute of Medicine (IOM) has published a report that addresses needs, goals, and initiatives to “reinvigorate” the National Cancer Institute’s (NCI’s) cooperative group trials program (www.nap.edu/catalog/12879.html). Among other recommendations, the IOM called on NCI to increase reimbursement to trial sites and urged the American Medical Association to develop a Current Procedural Terminology-4 code that would increase reimbursement to providers who enroll patients and participate in clinical trials. The IOM also recommended that NCI work with a nonprofit foundation to develop a certification program for clinical trial sites.
Among informational resources related to clinical trials, Dr Zon cited a series in the Journal of Oncology Practice that addressed various aspects of clinical research, such as exemplary attributes of research sites, good clinical practice research guidelines, quality assurance, and education.
Quality Teams Make for Quality Research
The path to exemplary status as a research site begins with the creation of a research team that understands and strives to create a culture that is supportive to clinical research.
Physicians participating in clinical research must have a strong commitment to it and be willing to spend the extra time required to explain the trial process to patients, discuss treatment options, and obtain appropriate consent. Most steps in the research process, including forms and documentation, require the participating physician to sign off on them. Research physicians also must be prepared to attend institutional and investigator meetings related to the clinical research program and specific clinical trials.
“The main thing physicians have to offer is our time,” said Gary I. Cohen, MD, director of clinical research at the Berman Cancer Center in Baltimore, MD. “Our time has value, and we don’t want to give it away. If we are going to do clinical trials, we certainly want to manage our time properly, and having a team allows us to get that done in the most efficient way.”
Although the titles and responsibilities of other clinical research team members may vary somewhat from site to site, most teams share several key members, including research associates, research nurses, pharmacy and secretarial support, as well as physician leaders.
Clinical research associates screen patients and determine their eligibility to participate in a trial, and also prepares a duplicate or “shadow” medical chart for each trial participant. The shadow chart is stored separately and used for audit purposes. The clinical research pharmacist has responsibility for logging and monitoring use and storage of investigational drugs and distributes assigned study medications.
Physicians who participate in clinical research must have a strong commitment to research and be willing to spend the extra time required to explain the trial process to patients, discuss treatment options, and obtain appropriate consent. Most steps in the research process, including forms and documentation, require the participating physician to sign off. Research physicians also must be prepared to attend institutional and investigator meetings related to the clinical research program and specific clinical trials.
Operating a clinical research site requires a substantial financial commitment, Dr Cohen noted, and personnel costs usually represent the largest outlay. At his institution, salary and benefits for various members of the research team can range from $39,000 for a medical assistant to $98,000 for a research nurse.
Personnel costs account for about three fourths of expenditures for a site’s research program. Of equal importance, the clinical research team must have the resources necessary to carry out their work, including workspace, telephone/telecommunication support, and computer equipment and software, Dr Cohen added.
The considerable overhead costs associated with operating a clinical research site require income to offset those expenses. A site may not make money, but it also should not lose money, which necessitates a “cost-neutral” financial balancing act, Dr Cohen said.
Budgeting and Paying for Trials
Contract negotiation is the fulcrum in the balancing act, and the negotiation process has no hard and fast rules. “Sponsors will not pay more than fair market value for services,” said Dee Anna Smith, chief executive officer of the Sarah Cannon Research Institute in Nashville, TN. “There is no clear mechanism in the law or regulations for determining fair market value in the clinical research context,” she said. “Well-documented justification [of costs] increases the likelihood that a sponsor will agree to your budget.”
The budget for a clinical trial allocates and documents financial responsibility among the sponsor, the research site, the patient, and insurance provider. An effective budget process should include a thorough review of the protocol and informed consent; careful justification of all costs; determination of institutional requirements; and a thorough delineation of all overhead costs, as well as identification of hidden costs. One of the most difficult aspects of the process involves estimating or accounting for inflation in multiyear projects, Ms Smith noted. However, cost estimations of future required procedures must include an allowance for inflation.
Identifying hidden costs is more problematic for new research sites than for experienced sites. Often overlooked are costs associated with site selection and visits, training the research staff, attendance at investigator meetings, development of study tools, and filing regulatory documents.
Other costs that should be taken into account include recruitment, pharmacy review, laboratory setup, quality assurance, radiology setup, monitoring, administration of the study drug, and pathology fees.
A research contract should clearly address indemnification, patient injury, and payment terms, Ms Smith said.
Indemnification typically includes protection for the sponsor, institution, and research site; use of study results; and product liability. Allowances for patient injury typically include direct medical costs; emergent and long-term care; and possibly, a monetary cap. Most contracts do not have allowances for incidental expenses resulting from injury, lost wages, pain and suffering, or punitive damages.
Payment terms will vary from site to site and sponsor to sponsor, but many agreements include some common traits. Ms Smith suggests that the terms stipulate advance payment of a nonrefundable fee for start-up costs, which most sponsors expect. Other issues commonly addressed in the agreement include:
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