PubMed · 8465705
The source did not provide an abstract. Follow the original record for more information.
Explore connections, maps & timelines
M A Dewar, S V McCrary, W L Allen. 1993. Medical malpractice.. https://pubmed.ncbi.nlm.nih.gov/8465705/
Cite the original work for its findings. Save a collection to share your selection of sources.
KEEP EXPLORING
BACKGROUND: Phase I oncology trials offer no meaningful chance for direct medical benefit and they may prevent patients with advanced cancer from receiving palliative care in a hospice program. However, it is not known whether dual enrollment in a Phase I trial and hospice is feasible. METHODS: Five hundred thirty-four Phase I trials were identified in a national online database, of which 179 (34%) accepted patients with a life expectancy of less than 6 months. Of these, 50 were selected randomly. Their principal investigators were surveyed by fax, with follow-up telephone calls and e-mails. Ninety-two hospices were selected randomly from a national database. Surveys were conducted by telephone with intake coordinators. Principal investigators were asked whether patients enrolled in hospice could also enroll in their trials if they were eligible in all other respects. Hospice intake coordinators were asked whether a patient with advanced cancer who met hospice eligibility criteria could also enroll in a Phase I trial. RESULTS: Surveys were completed by 45 of 50 principal investigators (90%) and by 89 of 92 hospices (97%). Although both groups were in favor of dual enrollment, principal investigators (41 of 45; 91%) were more likely to support dual enrollment than hospices (60 of 89; 67%; chi-square test, P = 0.004). Most hospices that did not support dual enrollment cited reasons that were based on concerns about payment or misunderstandings about the nature of Phase I trials. CONCLUSIONS: Most hospices and Phase I principal investigators believe that eligible patients should be allowed to enroll simultaneously in hospice and Phase I trials. These results suggest that the choice between hospice and a Phase I trial is a false dilemma and that greater collaboration in this area is needed.
BACKGROUND: The literature continues to report low rates of accrual to cancer clinical trials. Previous studies have examined principally physician-related or patient-related barriers. Clinical research associates (CRAs) have a unique perspective on enrollment that has been explored very little. This study sought the views of CRAs on barriers and facilitators to accrual. METHODS: Focus groups were held at six of eight tertiary cancer centers in Ontario, Canada. Audiotapes of sessions were transcribed and subjected to content analysis by two of the authors. Emergent themes were identified. These themes are illustrated by representative quotes taken from the transcripts. RESULTS: Factors that acted as barriers or facilitators were classified into physician-related, patient-related, or system-related factors. CRAs identified physician attitudes regarding patient participation as the principal physician-related barrier. Barriers, facilitators, and modifying factors that were related to patient involvement were discussed by CRAs. Patients seemed more knowledgeable about trials than in the past and were willing to participate. System factors were considered to have the greatest impact on the ability to accrue. CRAs identified increasing trial and pharmaceutical demands coupled with tight trial time lines. Time was seen as a diminishing resource. Greater demands not only affect specific clinical trial accrual but also affect general support for trials in the cancer center and hospital. CONCLUSIONS: The impact of greater demands in a climate of decreasing health care resources is perceived by CRAs as having a negative affect on accrual. Consequently, the important process of translating potentially beneficial basic research findings into clinical practice is slowed.
BACKGROUND: The multiple determinants of a patient's decision to enter into a clinical trial have been explored largely from the perspectives of patients and their physicians. Little research has involved clinical research associates (CRAs) formally, despite their central role in the process of recruitment. The current study was initiated to explore the factors that influence the decision of patients with cancer regarding clinical trial entry, specifically from the perspective of the CRA. METHODS: Two focus groups of CRAs from the Hamilton Regional Cancer Center were organized. A skilled facilitator guided both groups through exploratory and subsequent confirmatory phases of discussions, which were audiotaped for review and coding using a process of consensus employing intercoder triangulation. RESULTS: The two groups identified a number of factors that they believed influenced the recruitment process. Numerous physician and patient factors were reaffirmed, such as the impression of the scientific merit of a study or the sense of personal benefit, respectively. More uniquely, CRAs identified information transfer within the informed consent process as a major aspect of their specialized role. It was believed that full disclosure of information, in terms of both the content and the techniques and styles of delivery, was an important predictor of recruitment success. The groups quickly reached consensus on which factors they believed were the most important overall with respect to influencing study recruitment. CONCLUSIONS: CRAs appear to have a unique role in the process of recruiting patients to active clinical trials. They believe that they have an important influence on recruitment success. Further research to validate this impression is required, because, ultimately, a greater understanding of the relative roles of physician and patient factors and, potentially, CRA factors will be important in the development of ethical and supportive strategies to optimize the recruitment of patients with cancer into randomized clinical trials.