Eligibility For Phase Research Articles

Evaluation of Electronic Activity Monitors (EAMs) during phase I clinical trials.

e18175 Background: EAMs are wearable devices that record aspects of activity, including heart rate and step count. Medical oncologists use performance status (PS) (such as ECOG and Karnofsky) to assess patient’s physical function and to aid treatment decisions. These are subject to patient and physician bias. Our study evaluated the use of EAMs (Fitbit ®) during phase I trials, correlating EAM indices with PS and patient outcomes. Methods: We recruited patients in an academic hospital Drug Development Unit. Patients participating in a phase I trial consented to wear an EAM prior to starting and during the first treatment cycle. Physicians assessed PS at 4 timepoints. Outcomes (progression free survival (PFS), overall survival (OS), adverse events) were recorded. Results: Twenty-five patients were enrolled. At the time of data analysis results were available for 16 patients. Patients wore the EAM for an average of 70.3% (standard deviation 21%) of their time on study, defined as time with recordable heart rate. Mean step count per day varied with ECOG PS although the correlation did not reach statistical significance (co-efficient -1611.1 steps for each change in ECOG PS, p = 0.07, mixed effect regression model). A higher mean step count/day correlated with longer OS (HR0.67, p = 0.01, Cox proportional hazard model). Physician-assessed PS did not correlate with OS (HR2.65, p = 0.37, Cox proportional hazard model). There was no correlation between mean step count and PFS (HR1.7, p = 0.39, Cox proportional hazard model). Conclusions: The use of EAMs is feasible in this patient group. A higher step count correlated with longer OS whereas physician-assessed PS did not. Further research into the potential of EAMs as a means of predicting patient survival to guide decisions on eligibility for phase I trials and the potential for devising a revised Royal Marsden prognostic score incorporating EAM indices is warranted. Clinical trial information: SE536. [Table: see text]

Eligibility for phase 3 clinical trials of systemic therapy in real-world patients with metastatic renal cell cancer managed in a rural region.

Previous research has identified disparities between urban and rural cancer care, including clinical trial access. Therefore, we addressed three different questions in patients with metastatic renal cell cancer managed according to national guidelines in a rural Norwegian standard practice setting. (1) How many patients would have been eligible for three recent landmark randomized clinical trials? (2) Is survival different between eligible and non-eligible patients receiving first-line systemic therapy? (3) Is survival different between eligible patients and published trial results? We performed a retrospective analysis of 101 consecutive patients (2006-2016). Only 52% of the patients were eligible for the first-line study of pazopanib versus sunitinib. The main reasons for violating inclusion or exclusion criteria were presence of brain metastases, absence of clear cell histology, and poor performance status. Even fewer patients were eligible for trials of nivolumab and cabozantinib in pre-treated patients. Eligible patients had significantly better survival than non-eligible patients, median 29.2 versus 8.5months (p=0.0001). These results confirm that many patients from rural practices do not fulfill all mandatory trial eligibility criteria. However, eligible patients managed according to national guidelines had survival outcomes in line with published first-line trial results.

Potential cytochrome P-450 drug-drug interactions in adults with metastatic solid tumors and effect on eligibility for Phase I clinical trials.

Potential cytochrome P-450 (CYP) drug-drug interactions in adults with metastatic solid tumors and their effect on eligibility for Phase I clinical trials were characterized. This study included adult patients with metastatic solid tumors seen by a medical oncologist from January 2008 through July 2011. The medications used by these patients were identified. Each medication's potential for interacting with CYP isozymes was also characterized. Medication changes required to meet Phase I trial eligibility criteria were also reviewed. Data from 1773 patients were analyzed: 1489 were not enrolled in a Phase I trial and 284 were enrolled in a Phase I trial. Polypharmacy was significantly more prevalent in the group enrolled in a Phase I trial compared with those not enrolled (95% versus 80%, p < 0.001). The majority of patients not enrolled in a Phase I trial were taking at least one CYP isozyme inhibitor (87%) and at least one CYP isozyme inducer (45%). In a separate analysis, four Phase I trials were evaluated. Of 295 screened patients, 3.2% could not enroll due to concurrent medications. Charts from 74 enrolled patients revealed 655 concurrent medications—93 medications required further review for eligibility involving 51 (69%) of patients. Of the 93 medications, 38 (41%) were stopped and 41 (44%) were changed for the study. Polypharmacy and the use of medications that interact with CYP isoyzmes were common in adult patients with metastatic solid tumors. Patients enrolling in Phase I studies often require medication changes to meet eligibility requirements.

Capacity and equity in cardiac rehabilitation in the eastern region: good and bad news

To document current baseline eligibility for Phase 3 cardiac rehabilitation (CR) and the capacity to meet this need in hospitals in the Eastern Regional Health Authority. Information on the eligible population and the capacity for CR was collected in all nine hospitals retrospectively (February-March 2001). Forty-seven per cent of eligible patients were invited to participate with only two-thirds attending. Completion rates were very high (89%) in attenders. Age and health board area were significant independent predictors of being invited to CR. Gender was not independent of age. Fifty-three per cent of the need for this service was met by capacity in the region's nine hospitals in 2000 rising to 59% in 2002. Many eligible patients are not invited to CR. Lack of capacity is a problem. Among the invited, non-participation is a factor. Inequity in age and inter-hospital variation in invitation is noted.

Clinical impact of hypnotic-titration guidelines based on EEG Bispectral Index (BIS) monitoring during routine anesthetic care

Clinical impact of hypnotic-titration guidelines based on EEG Bispectral Index (BIS) monitoring during routine anesthetic care

Eligibility for phase III of the American Board of Orthodontic

Eligibility for phase III of the American Board of Orthodontic