Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center. Barriers to clinical trial participation by older women with breast cancer. Accrual to breast cancer clinical trials at a university-affiliated hospital in metropolitan Detroit. Recruitment of patients to cooperative group clinical trials. Participation and successful patient recruitment in primary care. General practitioners' views on patient care research. Recruitment of general practitioners and patients in a sore throat study. Selection bias in clinical trials. Factors affecting general practitioner involvement in a randomised controlled trial in primary care. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists.
The practice patterns of medical oncologists at a large National Cancer Institute Comprehensive Cancer Center in Detroit, MI were evaluated to better understand factors associated with accrual to breast cancer clinical trials.
                From 1996 to 1997, physicians completed surveys on 319 of 344 newly evaluated female breast cancer patients. The 19-item survey included clinical data, whether patients were offered clinical trial (CT) participation and enrollment, and when applicable, reasons why they were not. Multivariate analyses using logistic regression were performed to evaluate predictors of an offer and enrollment.
                The patients were 57% white, 32% black, and 11% other/unknown race. One hundred six (33%) were offered participation and 36 (34%) were enrolled. In multivariate analysis, CTs were less likely offered to older women (mean age, 52 years for those offered v 57 years for those not offered; P =.0005) and black women (21% of blacks offered v 42% of whites; P =.0009). Women with stage 1 disease, poor performance status, and those who were previously diagnosed were also less likely to be offered trials. None of these factors were significant predictors of enrollment. Women were not offered trials because of ineligibility (57%), lack of available trials (41%), and noncompliance (2%). Reasons for failed enrollment included patient refusal (88%) and failed eligibility (12%).
                It is important for cooperative groups to design studies that will accommodate a broader spectrum of patients. Further work is needed to assess ways to improve communication about breast cancer CT participation to all eligible women. Although 48% of breast cancer patients are 65 years old or older, these older patients are severely underrepresented in breast cancer clinical trials. This study tested whether older patients were offered trials significantly less often than younger patients and whether older patients who were offered trials were more likely to refuse participation than younger patients.
                In 10 Cancer and Leukemia Group B institutions, using a retrospective case-control design, breast cancer patients eligible for an open treatment trial were paired: less than 65 years old and > or = 65 years old. Each of the 77 pairs were matched by disease stage and treating physician. Patients were interviewed as to their reasons for participating or refusing to participate in a trial. The treating physicians were also given questionnaires about their reasons for offering or not offering a trial.
                Sixty-eight percent of younger stage II patients were offered a trial compared with 34% of the older patients (P =.0004). In multivariate analyses, disease stage and age remained highly significant in predicting trial offering (P =.0008), when controlling for physical functioning and comorbidity. Of those offered a trial, there was no significant difference in participation between younger (56%) and older (50%) patients (P =.67).
                In a multivariate analysis including comorbid conditions, age and stage were the only predictors of whether a patient was offered a trial. The greatest impediment to enrolling older women onto trials in the setting of this study was the physicians' perceptions about age and tolerance of toxicity. Despite the large number of available studies, most women with breast cancer do not participate in clinical trials, and this is especially true among lower income and minority women. In this study the authors surveyed the practice patterns of four medical oncologists who comprised the clinical breast service at a large urban university hospital to develop a better understanding of the clinical trials enrollment process for women with breast cancer. Of 136 new female breast cancer patients seen by the four physicians over a 7-month period, there were 47 women (34%) offered participation in a clinical trial, and 16 women (12%) were eventually enrolled. Women who were offered participation were more likely to be younger (p = 0.068) and to have earlier stage disease then were women not offered participation (p = 0.008). Women enrolled into a trial were also more likely to be younger, although this difference was not statistically significant (p = 0.114). Patient race was not associated with the accrual or enrollment process. Over half of the women were not offered participation in clinical trials because of the lack of available studies. Further work evaluating the process of patient enrollment and physician and patient barriers is necessary to develop effective strategies for recruitment into breast cancer clinical trials. One of the prerequisites for a successful clinical trial is the accrual of a sufficient number of patients for study. Because the sample-size requirements for a randomized clinical trial can rarely be met by a single institution in a short period of time, cooperative groups have taken in a major role in conducting clinical trials. In this paper, the recruitment of patients at our institution to a lung cancer clinical trial is evaluated. A total of 653 lung cancer cases were reviewed. Of the 77 cases which were eligible for the trial, 41 were accessioned. The reasons why eligible patients were not accessioned to the trial are discussed. The demand for family physicians (FPs) to participate in research is growing. The delicate balance between research participation and the daily practice routine might explain the often-disappointing number of patients recruited. We analyzed practice and physician characteristics associated with successful patient recruitment.
                We used a survey to conduct this study.
                There was a total of 165 FPs who participated in a combined randomized clinical trial/cohort study on drug treatment of dyspepsia in the Netherlands.
                We surveyed FPs about personal and practice characteristics and their motivation for participation in the project. These data were then related to the number of patients recruited. Univariate associations were calculated; relevant factors were entered into a logistic model that predicted patient recruitment.
                Data on 128 FPs could be analyzed (80% response rate); these FPs recruited 793 patients in the cohort study (mean = 6.3 per FP) and 527 in the clinical trial (mean = 4.2 per FP). The main reasons for participation were the research topic (59%) and the participation of an academic research group in the study (63%). Many FPs felt that participation was a professional obligation (39%); the financial incentive played a minor role (15%). The number of recruited patients was only independently associated with the participation of an academic research group.
                Successful patient recruitment in primary care research is determined more by motivation driven by the research group than by financial incentives, the research topic, or research experience. Little research has been undertaken into the factors affecting recruitment by Australian general practitioners of patients for clinical trials. Understanding the differences between recruiters and non-recruiters will assist researchers in better supporting general practitioners involved in such research.
                A survey of general practitioners involved in recruiting patients for clinical trials for the RACGP Research Program was undertaken.
                Recruiters were more likely to be interested in learning more about research, to perceive involvement as worthwhile, to desire a good relationship with Research Program staff and to feel the doctor-patient relationship assists recruitment.
                Recruiters in general are average general practitioners, male, middle-aged and work in group practices. Most felt some discomfort in recruiting patients, but believed the strong doctor-patient relationship assisted in the process.
                The Research Program needs to recruit general practitioners interested in research, choose topics of interest, keep recruitment protocols simple and stay in contact. nan Of 90 patients with intermediate or high-grade sarcoma eligible for a randomized trial of adjuvant doxorubicin (Adriamycin, Adria Laboratories, Columbus, Ohio), 48 were not entered: 24 (27%) by physician's choice and 24 refused randomization. Sixty-five percent of lower stage patients were randomized compared with 37% of those with higher stage (P = .02). Patients with extremity lesions were more frequently offered participation in the study (P = .07). Patients with lower stage lesions accepted randomization more readily than those with higher stage lesions (P = .01). As predicted by the higher stage and percentage of central lesions, the disease-free survival of nonrandomized patients was inferior to that of randomized patients (P = .15). Thus, patients at high risk appeared to avoid randomization and adjuvant doxorubicin in this trial, resulting in an inferior disease-free survival for the nonrandomized control group. Important questions generally require randomized trials that reliably determine relative treatment differences. If, however, the patients in a clinical trial are not representative of the entire patient population because of patient and physician selection biases, the generalizability of the results to the entire patient population may be compromised. For example, the prognosis of the general population cannot necessarily be inferred from the selected group in the study. In this study, the randomized and nonrandomized series yielded differing conclusions regarding treatment efficacy, even when an adjustment was made for known prognostic facts. To investigate factors associated with patient recruitment by general practitioners (GPs) in a randomised controlled trial in primary care.
                Cross sectional survey of 100 GPs who had agreed to recruit patients for a randomised controlled trial. A postal questionnaire was sent to the 100 GPs to collect information on factors associated with recruitment in the randomised controlled trial.
                The response rate to the survey was 97%. GPs who reported that practice nurses were involved in the research project were significantly more likely to recruit patients into the trial. Age, sex, membership of an independent practitioner association (IPA), number of half days worked, and the number of GPs working in a practice were not associated with recruitment.
                Involvement of practice nurses together with GPs may improve recruitment of patients in randomised controlled trials in primary care in New Zealand. We studied the reasons surgical principal investigators chose not to enter patients in a large, multicenter trial sponsored by a cooperative group. In 1976 the National Surgical Adjuvant Project for Breast and Bowel Cancers (NSABP) initiated a clinical trial to compare segmental mastectomy and postoperative radiation, or segmental mastectomy alone, with total mastectomy. Because the low rates of accrual were threatening to close the trial prematurely, we mailed a questionnaire to the 94 NSABP principal investigators, asking why they were not entering eligible patients in the trial. A response rate of 97 per cent was achieved. Physicians who did not enter all eligible patients offered the following explanations: (1) concern that the doctor-patient relationship would be affected by a randomized clinical trial (73 per cent), (2) difficulty with informed consent (38 per cent), (3) dislike of open discussions involving uncertainty (22 per cent), (4) perceived conflict between the roles of scientist and clinician (18 per cent), (5) practical difficulties in following procedures (9 per cent), and (6) feelings of personal responsibility if the treatments were found to be unequal (8 per cent). Further investigation into the behavioral aspects of the investigator-patient relationship is particularly pressing, since fear of change in this relationship was the most common reason given for not entering eligible patients in the trial. To improve understanding of physicians' reluctance to refer patients to clinical trials.
                This study was conducted in a large metropolitan region from 1993 to 1995 using a two-staged population-based sampling strategy. A total of 147 physicians discussed 245 patient cases and their own knowledge, attitudes, and practices toward clinical trials.
                Ninety-three patients (38. 0%) were offered a trial, and 49 (52.7%) of them agreed to participate. Forty-five patients (18.4%) actually received their adjuvant therapy on trial. Older patients and those with a poorer prognosis were less likely to be referred. Patients who delayed their decision were more than three times as likely to participate in a trial and more than eight times as likely to participate when they were reported to be actively involved in making the decision. Generally, physicians in university settings and who had formal support from a cooperative group were more likely to refer patients to trials. More specifically, surgeons referred more patients to trials when they felt comfortable explaining trials or believed that treatment should not stray from protocol. Oncologists were less likely to make referrals if they perceived the paperwork to be onerous or entry requirements to be too stringent. Surgeons' participation in recommending adjuvant therapy to patients resulted in more trial referrals unless they treated their patients with tamoxifen.
                (1) Physicians still need to overcome attitudinal and practical barriers to trial participation, (2) more support for physicians is needed, (3) surgeons may play a pivotal role in the recruitment of patients to adjuvant therapy trials, and (4) garnering patient enthusiasm for trial participation and involving them in the choice of adjuvant therapy may be key components to increasing trial enrollment.
The impact of factors varied across studies. Researchers need to be aware that aspects of the design and conduct of trials can affect clinicians' willingness to invite patients to participate. Further research is needed.