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Examples show how selected winners of ASCO's Clinical Trials Participation Awards are using new technologies to support their clinical research programs.
ASCO Cancer Foundation, ASCO's philanthropic arm, presented 10 community oncology practices with Clinical Trials Participation Awards for their efforts to improve the care of people with cancer through participation in clinical trials. These awards were presented this past June at ASCO's 44th Annual Meeting in Chicago, Illnois. This article begins a series focusing on members of these Clinical Trials Participation Award–winning practices. An understanding of how these sites conduct clinical research should be useful for other practices that are striving to improve their clinical research programs.
This article provides examples of how selected winners are using innovative technology to support their clinical research programs. These practices include Cancer Care Specialists of Central Illinois, Decatur, Illinois; Texas Oncology-Baylor Sammons Cancer Center, Dallas, Texas; and MeritCare Roger Maris Cancer Center, Fargo, North Dakota.
A major obstacle practices conducting research face is the difficulty in accruing patients because without patients there can be no trials. Obstacles hindering recruitment include identifying the right trial for patients, keeping clinicians informed of open trials, and dedicating the time and administrative resources required to open trials and keep them actively moving toward completion. The three practices featured in this article are using technology to address the challenges of accruing appropriate patients to open trials in a timely manner. Their solutions include the use of public Web sites with information on open clinical trials, electronic notification to staff about open trials, and the use of databases to identify new and returning patients who might be eligible for trials.
Texas Oncology-Baylor Sammons Cancer Center participates in oncology research primarily through the US Oncology Research network. The practice has adopted a variety of technologies to address these barriers to patient recruitment. Dr Joanne Blum, Director, Hereditary Cancer Risk Program at the Baylor-Sammons Cancer Center and US Oncology Research Site Leader, Texas Oncology-Sammons Cancer Center, said, “One of the main reasons for our high patient accrual within the US Oncology Research network is the leadership many of our physicians provide in the US Oncology disease-specific committees and the major role many of us play in clinical trial development.”
An extremely valuable technique to boost accruals is the use of US Oncology Research's Clinical Trial Management System (CTMS). All of the physicians within the network, as well as research staff, have access to this system via personal Internet and handheld wireless devices. CTMS allows access to all protocols, investigator brochures, consent forms, safety reports, regulatory documents, and other study-specific tools. Protocols can be searched by study number, title, disease, sponsor, and or clinical site within the network, and the system can be used to obtain a list of all open, closed, and pending trials available to their site. MyOncology Workspace is US Oncology's Intranet site that was launched in January 2007. The Workspace is a network communications center that allows access to real-time information and important documents, and promotes the exchange of ideas. The Practice Marketing Resource Center, available on MyOncology Workspace, can be used to find an array of recruitment tools including posters, clinical trial information forms, patient brochures, letters on specific trials, ads focused on research, and media relations material.
US Oncology coordinates monthly Clinical Research Coordinator educational and network operational teleconference calls. The call agenda varies from month to month; however, recruitment and retention techniques are frequent topics. An archive of educational and operational calls is located on the CTMS. The Learning Connection, US Oncology's online training and learning Web site, is a valuable educational resource for Texas Oncology-Baylor Sammons Cancer Center physicians and staff. Among the courses are some that relate to accrual, such as good clinical practice training and informed consent process.
Other initiatives aimed at patient education and outreach include a marketing campaign created at Baylor Sammons Cancer Center that educates the community about how Baylor University Medical Center is applying advances in research and medical knowledge to the patient bedside. It includes a brochure answering basic questions, such as “What is a clinical trial?”, and information on adverting to potential participants (ie, billboard, print, and radio advertising, and study-specific press releases). Texas Oncology-Baylor Sammons Cancer Center sends Baylor University Medical Center monthly listings of available open trials, which are incorporated into this marketing plan, and listed on Baylor's Web site with a link to US Oncology Research for specific study and contact information.
Maintaining a broad trial portfolio, promoting awareness of those trials, and finding eligible patients are major barriers to accrual for this practice, which is a cofounding group of the Central Illinois Community Clinical Oncology Program. A multitiered, team approach is being used to keep oncologists informed of trial options. This includes a monthly meeting with the research administrative staff to make sure there are trials open for the common malignancies, updating the open trial menu monthly, and making it available to their physicians as a printed booklet, a downloadable PDF, and a current list online. Weekly meetings to discuss new cases and weekly tracking of accrual by each physician are part of the way this practice enforces their belief that participation in clinical trials is expected and a way to demonstrate quality medical care.
Their team of clinical research associates (CRA) screens every new patient to the practice for possible study enrollment, and alerts the oncologists about which studies are available. All returning patients can complete, on every clinic visit, an electronic questionnaire (e-tablet) that includes a symptom check list. This is stored on a server, printed for the physician for that visit, and also reviewed by their quality-of-life CRA team to see if a symptom management study may be helpful. Karen Cheek, Director of Research, said that one drawback of the e-tablet system is that older patients are not as eager to use it as are younger patients.
This practice has found that identifying established patients as study candidates has been a challenge. New patients immediately “appear on the radar,” whereas those who have disease recurrence may move through the system without being identified by study personnel until it is too late to consider them for an appropriate trial. New patient visits are reviewed by a CRA or research nurse before the appointment date to predetermine potential eligibility. An online flag is sent to the patient's physician that suggests presenting the research opportunity to the patient.
For the past seven years, MeritCare has been named among the 100 Most Wired Hospitals in the United States by Hospitals & Health Networks magazine. This is especially important because many of their patients travel a great distance for cancer care. Their rural patients find the scheduling of multiple appointments difficult to handle due to the additional time and costs of travel. The practice has been able to coordinate patient appointments to minimize the number of trips, and an electronic database allows oncologists to access the entire patient record when they travel to outreach clinics.
The creation of a research Web page on the institution's Web site in 2005 has allowed both patients and health care providers access to information about the clinical trials the practice conducts. Visitors to this Web site are able to search by specialty, condition, investigator, and sponsor. Once a study is selected, visitors are able to view key inclusion and exclusion criteria, and obtain a contact name and phone number for more information. Additional community outreach has been provided since 2006 by a trained patient advocate for clinical trials. A fund-raiser hosted by a local radio station also provides an opportunity for the Community Clinical Oncology Program principal investigator and other staff to educate the public about the benefits of clinical trials in oncology.