Mehmet Sitki Copur, MD, FACP
HISTORICALLY, CLINICAL research has been viewed as an entity belonging to academic settings alone. With the advent of the Community Clinical Oncology Program (CCOP) in the 1980s and later with the Cancer Trials Support Unit, cancer clinical trials have begun to emerge in the community setting. Professional oncology organizations such as the American Cancer Society, the Commission on Cancer, and the National Comprehensive Cancer Network® (NCCN®) have long required and/or endorsed clinical trial participation as a high-quality indicator for cancer care. Community oncology practices are ideal clinical trial sites.
With the availability of the Internet reaching virtually everyone, patients with cancer are now more informed and aware of the latest treatments. To compete in the marketplace, community oncologists must be able to offer innovative and current cancer care through clinical trials. More and more community oncology practices are striving to provide clinical trials to their patient population.
How Do Community Oncologists Become Principal Investigators?
MANY PASSIONATE community oncologists may want to offer this service and are interested in being principal investigators. Depending on where they completed their fellowship training programs, they all have had some but variable exposure to the clinical trial process. However, during training, most oncology fellows including myself were most interested in scientific concepts and the possible advances that these clinical trials would bring to patient care and may have paid little to no attention to the infrastructure needed to conduct these trials, regulatory requirements, institutional review boards, audits, adverse event reporting and electronic data-entering requirements, and principal investigator responsibilities.
So where do interested community oncologists start to build a clinical trials program? What are the first steps? To whom can they go for guidance?
I have long been appalled by the lack of training, guidance, and education on this aspect of oncology training in almost all of oncology fellowship programs, as well as the lack of testing on this topic in medical oncology specialty board exams and recertification exams. Mostly, community oncologists are on their own. Interested oncologists must make time and learn how to build an infrastructure at the cost of sacrificing time from all other duties while trying to provide the best cancer care to their patients.
Starting a clinical trial program is not a small task and can have many pitfalls. There are more challenges in the community setting than in the academic university setting. The need for experienced physician investigators and nurse coordinators as well as the vast heterogeneity of different community oncology practices are just a few of them. The good news is community oncologists are not alone. There are resources that are becoming more and more available to community oncologists.
For simplicity, I will focus on the two most common types of community oncology practices: hospital-based vs self or group-employed community oncology practices.
First Steps for Community Hospital–Based Oncology Practices
Evaluate Institutional Commitment: Philosophic and financial dedication of the hospital is crucial in this setting. First, meet with the key people of the hospital to confirm that they understand the burden that accompanies setting up a clinical trials program. Also highlight the fact at the beginning a clinical trial may not be profitable, but over time it may become a break-even or profitable endeavor. Yet it does not have to be. This is meant to be a service to patients and our community by way of providing the best cancer care and scientific advancements.
If there is more than one community hospital in the area, medical staff may be affiliated with more than one hospital, resulting in a fragmented framework. In my experience, fortunately, I have seen more cooperative tendencies among ancillary departments of different community hospitals, as for many years they have had a servicing attitude to keep physicians on staff, which carries over to all areas. This may be a clear advantage to starting a research program in a community hospital–based setting. Although a strong effort should be made to achieve a cooperative relationship with ancillary departments of hospital-based oncology programs, the existence of more than one private practice physician group may require more coordination and attention among different stakeholders.
Check Available Resources: It will be necessary for community oncologists to know the target population, the cancer registry data, as well as the number of new patients diagnosed each year at the clinics of the hospital and/or the hospitals with which they are affiliated. About 2% to 8% of new patients will be eligible and consent to participate in clinical trials, so it is necessary to learn whether there is enough of a patient population from which to draw. This crucial information is the first step in starting a research program and in assessing the ability of a community hospital and staff to conduct clinical trials.
Next, community oncologists who are not in a solo practice will need to evaluate the physicians in their group as well as in competing groups as potential study investigators. What is their background in research? Have they successfully conducted clinical trials in the past? Are they passionate about clinical trials? Do they belong to the same practice group or come from competing groups?
When setting up an in-house program, make sure that all groups can participate. This may be the most delicate part of setting up a clinical trials program. In the university setting, although all physicians of a specialty are under one department heading, this is not so straightforward in community setting practices, as there are financial competitions in place between different practice groups. The hospitals may not want to offend any physician on staff. It will be necessary to create team work and meet with each appropriate physician group separately to let them know of the goal for the patient population. Development of a respectful rapport from the beginning is essential.
Once potential investigators have been identified, it will be necessary to determine the community hospital’s ability to conduct research. Is there an institutional review board in place? If so, is it registered, and does it have an assurance number with the Office for Human Research Protections (OHRP)? If not, it may be necessary to contact the OHRP and apply for an assurance number (www.ohrp.osophs.dhhs.gov). The OHRP also has the information to set up an institutional review board from the ground up. This process can take time from 1 month (if some elements are already in place at the community hospital) to 6 months (if starting from scratch).
In addition to membership, policies and procedures will need to be in place. This can be a time-consuming process. For all of us practicing oncologists who have never had training on this topic, this task can be intimidating. We do not have the time to study and learn all these complicated regulatory requirements. To get around this challenge, find an affiliate institution and use its institutional review board as the institutional review board of record. I have found this to be very helpful. Examples of possible affiliate institutions include the National Cancer Institute (NCI)-initiated programs (CCOP, National Cancer Institute–Community Cancer Centers Program, NCI–Community Oncology Research Program), academic medical centers, and nonprofit independent research organizations.
Finally, the availability of a pharmacist who is trained according to the U.S. Food and Drug Administration guidelines on conducting clinical trials is essential. The Code of Federal Regulations has the procedures for pharmacists to follow. Ideally, a dedicated pharmacist responsible for clinical trials’ implementation would be perfect; however, to begin, a part-time responsibility of an existing pharmacist would work and could expand as the research program grows.
Prepare Standard Operating Procedures: This step includes several categories. First, a policy and procedure manual reflecting adherence to all the Code of Federal Regulations requirements is necessary. This can be purchased from a commercial research organization or from an institution and can be adapted to the research program. If an affiliate institution is chosen, it may permit reformatting of its policies and procedures.
The second category is protocol management, which includes areas of study initiations, institutional review board submissions and communications, site visits, communications with sponsors, drug-monitoring procedures, management of regulatory documents and patient information, and close out of studies.
The third category is human subject management. This refers to the procedures that the program will be utilizing for screening, recruiting, entering, and monitoring patients on protocols, follow-up procedures, and any other special procedures that might be routinely performed.
The fourth category centers on data management, which includes all procedures the department will be following for collection, maintenance, and submission of clinical trial data. The Health Insurance Portability and Accountability Act regulations on this area should also be reviewed.
The final category is quality management, which refers to all of the policies stating how the program will monitor adherence to previous policies, including self-audits, internal audits, sponsor audits, and external audits. In addition, policies regarding conflict of interest, misconduct in science, and notification of patients of any new information or events regarding the clinical trials should be included under this category. The areas to be covered can be found by reviewing the Federal Policy for the Protection of Human Subjects.
In preparing these so-called standard operating procedures, a basic format should be applicable to any clinical trial. So, try to be as inclusive and generic as possible. Once the policy and procedure manual is complete, make sure the appropriate administrators and research team members read, sign, and date it. Also make sure to include a policy for reviewing this policy and procedure manual periodically.
First Steps for Self- or Group-Employed Community Oncology Practice
SELF-EMPLOYED OR group practice–employed community oncologists will need to follow the same regulatory steps as previously mentioned. However, the difference in this setting is the need to be more involved and responsible to adhering to federal regulations, guidelines, and other standards that address the conduct of human participant research and protection. The principal investigator will be the one making the medical decisions, providing adequate care to study patients according to the clinical trial protocol. It will be necessary to carefully review the scientific, ethical, and financial merits of trial participation. The steps previously described for hospital-based oncology practices apply here as well.
Obviously, in this setting, the community oncologist or group practice will ultimately be responsible for the entire operation. Hiring the ideal study coordinator(s)—preferably someone with prior experience, certification, and an ability to conduct the procedures listed previously—is crucial.
“Hiring the ideal study coordinator(s)—preferably someone with prior experience, certification, and an ability to conduct procedures—is crucial.”— Mehmet Sitki Copur, MD, FACP
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Understanding clinical research budgeting and billing compliance will play a big part in the success of the practice, which is also as relevant and important for hospital-based oncology practices. It is crucial to know how to develop a budget for the trial, identify all clinical trial–related costs, determine and designate the standard-of-care costs vs sponsor-paid costs, as well as identify and document all research participation and services. Data management in the self or group practice setting is as critically important as it is in the hospital-based setting. An infrastructure that makes it possible to support the data collected from the research patient population (both paper and electronic) is crucial to ensure high-quality data within strict timelines and in compliance with federal, state, and local regulations as well as industry guidelines.
Ready, Set, Go!
HOPEFULLY, INTERESTED community oncologists are now ready to begin initiating clinical trials in the community practice setting and offering cutting-edge medical care to patients right in their own neighborhoods. All processes should be reviewed, all I’s should be dotted and T’s crossed, and the community should be informed about the resources available. As many of my colleagues will attest, clinical trial participation can provide personal and professional satisfaction. Whatever the goal, it’s important to prepare for what needs to be done, so the trials are successful from business, patient, and personal standpoints. ■
Dr. Copur is a community oncologist at Medical Oncology/Hematology, Morrison Cancer Center, Mary Lanning Healthcare, Hastings, and Professor at the University of Nebraska Medical Center, Omaha.
DISCLOSURE: Dr. Copur has received honoraria from Amgen, Bristol-Myers Squibb, DAVA Oncology, and AstraZeneca.