Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital

Ho, Jeremy; Pond, Gregory R.; Newman, Charles; Maclean, M.; Chen, Eric X.; Oza, Amit M.; Siu, Lillian L.

doi:10.1186/1471-2407-6-263

Cited by 55 publications

(61 citation statements)

References 8 publications

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“…An additional 34% of patients demonstrated less than a partial response or stable disease [1,6]. Despite the potential benefit of participating in a phase I trial, patients who are seen in a facility conducting phase I clinical trials may have enrollment delayed or may not be able to participate in a trial or may choose not to participate [8,9]. Enrollment delay may result in ineligibility of patients for a specific phase I trial because of continuous tumor progression-related systemic effect.…”

Section: Introductionmentioning

confidence: 99%

Barriers to Study Enrollment in Patients With Advanced Cancer Referred to a Phase I Clinical Trials Unit

McQuinn

Naing

et al. 2013

The Oncologist

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Section: Introductionmentioning

confidence: 99%

Barriers to Study Enrollment in Patients With Advanced Cancer Referred to a Phase I Clinical Trials Unit

McQuinn

Naing

et al. 2013

The Oncologist

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“…On the other hand, physician triage is pointed out to be one of the barriers to cancer clinical trial accrual (Lara et al, 2001;Corrie et al, 2003;Go et al, 2006;Ho et al, 2006). We excluded the barrier by making it a rule to offer clinical trials to every patient with advanced NSCLC who satisfied the eligibility criteria.…”

Section: Discussionmentioning

confidence: 99%

“…The results of questionnaire surveys administered to patients regarding clinical trials revealed that two of the most common reasons for entering the trial were the hope for personal benefit and the opportunity to contribute to the research knowledge thereby benefiting others in the future (Jenkins and Fallowfield, 2000;Madsen et al, 2000Madsen et al, , 2002Ellis et al, 2001;Wright et al, 2004;Albrecht et al, 2008). On the other hand, the common reasons for declining participation were worries about the process of randomisation, overestimation of the benefits of standard therapy and fear of the trial's experimental nature (Jenkins and Fallowfield, 2000;Ellis et al, 2001;Ho et al, 2006).…”

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confidence: 99%

“…A number of studies have examined the motivations of patients for accepting or declining entry to RCTs (Jenkins and Fallowfield, 2000;Madsen et al, 2000Madsen et al, , 2002Ellis et al, 2001;Wright et al, 2004;Ho et al, 2006;Albrecht et al, 2008). The results of questionnaire surveys administered to patients regarding clinical trials revealed that two of the most common reasons for entering the trial were the hope for personal benefit and the opportunity to contribute to the research knowledge thereby benefiting others in the future (Jenkins and Fallowfield, 2000;Madsen et al, 2000Madsen et al, , 2002Ellis et al, 2001;Wright et al, 2004;Albrecht et al, 2008).…”

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confidence: 99%

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Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

Tanai

Nokihara

Yamamoto³

et al. 2009

Br J Cancer

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There are inadequate data on the outcomes of patients who declined to participate in randomised clinical trials as compared with those of participants. We retrospectively reviewed the patient characteristics and treatment outcomes of both participants and non-participants in the two randomised trials for chemotherapy-naive advanced non-small-cell lung cancer. Trial 1 compared four platinum-based combination regimens. Trial 2 compared two sequences of carboplatin plus paclitaxel and gefitinib therapies. Nineteen of 119 (16%) and 153 (37%) patients declined to participate in Trials 1 and 2, respectively. Among the background patient characteristics, the only variable associated with trial participation or declining was the patients' attending physicians (Po0.001). Important differences were not observed in the clinical outcomes between participants and non-participants, for whom the response rates were 30.6 vs 34.2% and the median survival times were 489 vs 461 days, respectively. The hazard ratio for overall survival, adjusted for other confounding variables, was 0.965 (95% confidence interval: 0.73 -1.28). In conclusion, there was no evidence to suggest any difference in the characteristics and clinical outcomes between participants and non-participants. Trial designs and the doctor -patient relationship may have an impact on the patient accrual to randomised trials.

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“…The historic response (1991-2002, NCI) rate for first-inhuman clinical trials is about 5 % while phase I trials in general resulted in a response rate of about 10 % [40]. Current late-phase clinical trials are based on testing novel combination of existing drugs or the addition of new drugs to standard therapy in large cohorts of patients to establish efficacy.…”

Section: Improving Clinical Trial Design In Amlmentioning

confidence: 99%

Novel agents in acute myeloid leukemia

Ungewickell

Medeiros

2012

Int J Hematol

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Although complete remissions can be achieved in most patients younger than 60 years of age with untreated acute myeloid leukemia (AML), only 30-40 % of patients remain long-term survivors. Furthermore, longterm survivors represent only 10-15 % of all AML patients older than 60 years of age and \10 % of all patients with relapsed AML. The development of new treatments for AML is therefore needed. Novel therapies should target specific mechanisms and pathways implicated in the development and maintenance of AML, should strive to have better tolerability than conventional combination chemotherapy, be associated with improved quality of life and minimize utilization of health care resources. In this manuscript, we discuss the role of epigenetic regulators and immunomodulatory agents in the treatment of AML. Also, we review the data on inhibitors of protein homeostasis and its synergistic effect to DNA methyltransferase inhibitors, the potential role for inhibitors of heat shock proteins and the mitotic machinery and a novel formulation of conventional chemotherapeutic agents given at a fixed molar concentration. Finally, we briefly share our views on optimal clinical trial design and patient selection for future studies in AML.

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Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital

Abstract: Background: There is a paucity of literature on the referral outcome of patients seen in phase I trial clinics in academic oncology centres. This study aims to provide information on the accrual rate and to identify obstacles in the recruitment process.

Cited by 55 publications

References 8 publications

Barriers to Study Enrollment in Patients With Advanced Cancer Referred to a Phase I Clinical Trials Unit

Barriers to Study Enrollment in Patients With Advanced Cancer Referred to a Phase I Clinical Trials Unit

Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

Novel agents in acute myeloid leukemia

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