Factors influencing inclusion of patients with malignancies in clinical trials (original) (raw)
Related papers
Trials, 2012
Background: Enrollment in interventional therapeutic clinical trials is a small fraction of all patients who might participate given reasonable access. Methods: A hierarchical approach is utilized in measuring staged participation from trial availability to patient enrollment. Our framework suggests that concern for justice comes in the design and eligibility criteria for clinical trials; attention to beneficence is given in the eligibility and physician triage stages. The remaining four stages rely on respect for persons. An example is given where reasons for nonparticipation or barriers to participation in prostate cancer clinical trials are examined within the framework. In addition, medical oncology patients with an initial six month consultation are tracked from one stage to the next by race using the framework to assess participation comparability. Results: We illustrated seven transitions from being a patient to enrollment in a clinical trial in a small study of prostate cancer cases who consulted SKCCC Medical Oncology Department in early 2010. Pilot data suggest transition probabilities as follows: 65% availability, 84% eligibility, 92% patient triage, 89% trials discussed, 45% patient interested, 63% patient consented, and 92% patient enrolled. The average transition probability was 77.7%. The average transition probability, patient-trial-fit was 50%; opportunity was 51%, and acceptance was 66.7%. Trial availability, patient interest and patient consented were three transitions that were below the average; none were statistically significant. Conclusions: The framework may serve to streamline comprehensive reporting of clinical trial participation to the benefit of patients and the ethical conduct of clinical trials.
Barriers and facilitators to enrollment in cancer clinical trials
Cancer, 2002
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.
Why don’t cancer patients enter clinical trials? A review
European Journal of Cancer, 2006
Despite widespread agreement about the value of clinical trials, the proportion of patients who are enrolled in such trials is often considered to be too low. A comprehensive literature search was carried out for the period 1980 to the present, in order to review current data on barriers and facilitators to the development of multicentre clinical trials. Of 364 articles initially identified, 35 articles and 1 book were selected in order to assess the reasons that doctors and/or patients participate in clinical trials. This review emphasises the fact that doctors play a key role in the development and non-development of clinical trials. More studies, in particular studies outside the United States of America (USA), are needed in order better to understand doctors’ attitudes towards clinical trials. Such studies should combine multivariate analyses and comparative approaches in order to associate doctors’ behaviours with their individual characteristics, with the organisational context of their working environment and with the healthcare system.
Internal Medicine, 2006
Objectives To examine the factors related to actual patient recruiters among the physicians who initially agreed to collaborate in a randomized control trial. Methods We conducted a questionnaire survey of 679 physicians (512 actual recruiter and 167 nonrecruiters) who had initially agreed to recruit patients for a clinical trial to determine factors to predict who would actually do so. Results Response rates among recruiters and non-recruiters were 87.5% and 73.1%, respectively. Multivariate logistic regression model showed that the proportions of regular users of computer [odds ratio (OR) =2.1, 95% confidence intervals (CI)=1.3-3.3] (p=0.002) and current participants in other clinical trials (OR=2.2, CI=1.5-3.4) (p=0.001) were significantly higher among recruiters than non-recruiters. Patients' reasons for non-participation as perceived by the physicians did not differ between recruiters and non-recruiters. Conclusion Results of this study might be useful in predicting actual recruiters at the outset of clinical trials.
BMJ open, 2022
OBJECTIVES Phase III cancer clinical trials are expensive and time-consuming phases in drug development. Effective patient enrolment can reduce delays and save costs, offering patients an opportunity to benefit from innovative treatments. However, the current evidence base does not fully explain the persistence of barriers to patient enrolment in phase III cancer clinical trials. The aim was to explore clinicians' and pharmaceutical representatives' views on these barriers. DESIGN A qualitative study was performed. In-depth information was collected from 15 experts in the field of oncology clinical trials, in particular clinical oncologists acting as principal investigators (PIs) and clinical research associates. By means of semistructured interviews, based on a questionnaire derived from our newly developed conceptual framework, they were asked to identify barriers to patient enrolment they had experienced and comment on barriers identified in literature. FINDINGS Existing ...
Cancer, 2002
BACKGROUNDThe 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.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.METHODSFocus 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.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.RESULTSFactors 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.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.CONCLUSIONSThe 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. Cancer 2002;95:1577–83. © 2002 American Cancer Society.DOI 10.1002/cncr.10862The 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. Cancer 2002;95:1577–83. © 2002 American Cancer Society.DOI 10.1002/cncr.10862