A call to action: patients' access to clinical trials.

The National Cancer Institute demonstrated its new Cancer Clinical Trials Education Program (CCTEP) at the American Association of Social Workers annual meeting in San Diego, California, in May 1998. The goal was to develop a cadre of social workers who could facilitate community outreach and health professional training using CCTEP. This article is an abridged version of that presentation. It raises awareness of the important role social workers can play in clinical trials recruitment, gives an overview of clinical trials, and suggests ways social workers can help facilitate accrual to clinical trials. Clinical trials are the gold standard by which new therapies are tested (Fisher, 1966; Hill, 1962; Kramer & Shapiro, 1984; Shapiro & Louis, 1983). The relatively small number of patients who are willing and eligible to participate in clinical trials and the large number of trials competing to accrue those patients (Antman, Schnipper, & Frei, 1988; Ellis, 1996; Smith & Ho, 1996) delay the flow of innovative treatments to the public. Fewer than 5 percent of patients age 20 and over participate in clinical trials (Cheson, 1991; Taylor et al, 1994). Of patients age 50 and over, the age group with the greatest cancer incidence, only 1.5 percent participate in trials (Avorn, 1997; Bugeja, Kumar, & Banerjee, 1997; Giovanazzi-Bannon, Radamaker, Lai, & Benson, 1994; McNeely & Clements, 1994; Tejeda et al., 1996). It has been estimated that if adult patients participating in clinical trials for the most common cancers could be increased to 10 percent, accrual for most studies could be completed in a year instead of the three to five years now required (personal communication with V. T., DeVita, 1998, professor, internal medical oncology, Cancer Center, University of California, San Diego). Although clinical investigators despair over the slow pace of clinical research, social workers know only too well the despair experienced by patients, for whom time is running out. In a search for successful models to increase accrual to clinical trials, the pediatric model stands out. Cancer is comparatively rare in children, but nearly every child with cancer is evaluated for clinical trial eligibility, and up to 80 percent of pediatric patients are placed in trials (Cheson, 1991; Tejeda et al., 1996). As a result, dramatic progress has been made in the treatment of many pediatric cancers (Pediatric Oncology Group, 1992). One important difference in the pediatric environment is that the entire interdisciplinary health care team is focused on reducing the pediatric oncologic death rate through clinical research. As key members of the clinical team, social workers are uniquely positioned to facilitate patients' awareness and understanding of clinical trials. The social worker holds a trusted relationship with the patient in which the concept of clinical trials can be introduced and explored and the patient directed toward more in-depth sources of information (Deininger, 1990; Deininger, Collins, & Hubbard, 1989; Edwards, 1997; Johansen, Mayer, & Hoover, 1991). There are many common concepts inherent in all clinical trials that social workers can help patients understand and encourage them to explore (Macomber & Sadler, 1997). OVERVIEW OF CLINICAL TRIALS One way to compensate for the difficult-to-control variables in human research is a highly structured and rigidly followed clinical trial protocol. The exact treatments to be offered in each arm of the study, the timetable for administration of the experimental and control interventions, the exact data-collection points, the duration and points of follow-up, and many other disease-specific characteristics are clearly delineated in the study methodology and rigidly followed (Meili, 1991). Having a large sample, a randomized trial design, and a highly sophisticated statistical analysis of the outcome data are three other ways to compensate for these difficult-to-control variables (Barnett et al. …