Use of a clinical trial screening tool to enhance patient accrual.

BACKGROUND: Clinical trial patient accrual continues to be challenging despite the identification of multiple physician, patient, and system barriers. Expanded collection of demographic data, including socioeconomic status (employment, income, education) and comorbidities, can enhance our understanding of the identified barriers, inform the development of interventions to overcome these barriers, and recognize their impact on treatment outcomes. A clinical trials screening tool was developed to collect expanded demographic data and barriers to trial enrollment; it has been implemented in the National Cancer Institute Clinical Oncology Research Program. The purpose of this article is to describe the development and implementation of the tool and to share information obtained during the first 43 months of its use. METHODS: There were 19,373 entries collected; 74% of those screened enrolled in a clinical trial. Demographic characteristics were compared between those screened and those enrolled. They varied significantly between the groups. RESULTS: Reasons for nonenrollment included ineligibility (50%), eligible but declined (47%), eligible but physician declined to offer participation (2%), and eligible but the study was suspended (1%). The most common reasons for ineligibility were failure to meet the protocol-specific stage of cancer, the presence of comorbidities, and the symptom-eligibility score was not met. The most common reason for eligible patients declining participation was that they had no desire to participate in research. CONCLUSIONS: The tool provides valuable information about the characteristics of individuals who are screened and enrolled in National Cancer Institute-sponsored trials, as well as about barriers to enrollment in trials. The data also inform protocol development and interventions at the patient, provider, and institutional level.

Chemotherapy-induced peripheral neuropathy: Identifying the research gaps and associated changes to clinical trial design.

BACKGROUND: To the authors' knowledge, the empiric identification of agents and interventions to mitigate chemotherapy-induced peripheral neuropathy (CIPN) has resulted in only 1 agent that modestly mitigates it and no agents or interventions that prevent its development. This speaks to the need for a mechanistic understanding of CIPN to develop effective interventions. METHODS: To understand the extent to which mechanistic understanding of CIPN is being translated into the development of interventions, the National Cancer Institute conducted a review of the National Institutes of Health (NIH)'s portfolio of investigator-initiated grants, the literature regarding CIPN mechanisms, and the clinical trials listed in the ClinicalTrials.gov database from January 1, 2011, to May 22, 2019. RESULTS: A total of 69 NIH-supported grants and 95 published articles were identified that evaluated mechanistic pathways of 7 different chemotherapy agents that cause CIPN. The review also identified 35 clinical trials that investigated agents or devices with which to treat CIPN. Only 3 trials incorporated a mechanistic rationale to support the choice of the intervention. CONCLUSIONS: To the authors' knowledge, very little of the mechanistic understanding of the development of CIPN is being translated into intervention rationale in clinical trials that evaluate interventions to mitigate CIPN. Efforts to incentivize this translation are needed.