7 to 16.2 weeks) prior to the full application submission. The median time from application submission to FDA approval was 3.3 months (range 0.4 to 5.9 months). RTOR was also integrated with other review programs including the Assessment Aid (AAid) and Project Orbis programs. Innovative regulatory processes are critical to expedite the rigorous review of impactful products across the FDA.

To determine the degree of cross-contamination and to validate a cleaning process for an Automated Personalised Dosing System (APDS), respecting the permitted residue transfer limits.

An analytical determination by high pressure liquid chromatography with mass spectrometry was performed for 11 drugs considered critical for their potential for contamination, toxicity (National Institute for Occupational Safety and Health (NIOSH) List 2016) and/or narrow therapeutic index. The test was carried out for three consecutive weeks, seven repetitions per week, in a state of maximum contamination and maximum cleanliness. The main validation criterion of the cleaning protocol was to quantify that the active ingredients measured were below the Permitted Daily Exposure index or fraction 1/1000 of the minimum daily dose, both in a state of maximum contamination and when the APDS is in a clean condition, for an average number of tablets consumed per person per day.

In all the samples analysed, some compound could always be quantified below 2% of the permitted transfer limits, highlighting the presence of paracetamol and carbamazepine. In the state of maximum contamination, the mean±SD values of paracetamol and carbamazepine were 5.83±1.56 µg and 0.22±0.07 µg, respectively, without significant differences in mean values over the 3 weeks of the study. After the cleaning protocol was executed, only paracetamol and carbamazepine were detected, with the average values being 4.67 µg (95% CI 3.92 to 5.43, p<0.05) and 0.07 µg (95% CI 0.03 to 0.10, p<0.05) lower than the state of maximum contamination, respectively.

In all cases the level of cross-contamination for an APDS was below the pre-established limits. The cleaning protocol has been validated, confirming APDS decontamination of the most critical medicines.

In all cases the level of cross-contamination for an APDS was below the pre-established limits. The cleaning protocol has been validated, confirming APDS decontamination of the most critical medicines.

Patient-clinician communication in the Emergency Department (ED) faces challenges of time and interruptions, resulting in negative effects on patient satisfaction with communication and failure to relieve anxiety. Our aim was to improve patient satisfaction with communication and to decrease related patient anxiety.

A multistage quality improvement (QI) initiative was conducted in the ED of Toronto General Hospital, a quaternary care centre in Ontario, Canada, from January to May 2018. We engaged stakeholders widely including clinicians, allied health and patients. We developed a 5-point Likert scale survey to measure patient and clinician rating of their communication experience, along with open-ended questions, and a patient focus group. Inductive analyses yielded interventions that were introduced through three Plan-Do-Study-Act (PDSA) cycles (1) a clinician communication tool called Acknowledge-Empathize-Inform; (2) patient information pamphlets; and (3) a multimedia solution displaying patient-directt meet significance. SPC charts showed special cause variation temporally associated with our interventions.

Our pragmatic low-cost QI initiative led to statistically significant improvement in patient satisfaction with communication and decreased patient anxiety while narrowly missing our a priori improvement aim of one full Likert scale point.

Our pragmatic low-cost QI initiative led to statistically significant improvement in patient satisfaction with communication and decreased patient anxiety while narrowly missing our a priori improvement aim of one full Likert scale point.

A phase I clinical trial (GOG-9929) examined the safety and efficacy of adjuvant immune-modulation therapy with the checkpoint inhibitor ipilimumab [anti-CTL antigen-4 (anti-CTLA-4)] following chemoradiation therapy (CRT) for newly diagnosed node-positive human papillomavirus (HPV)-related cervical cancer. To better understand the mechanism of action and to identify predictive biomarkers, immunologic and viral correlates were assessed before, during, and after treatment.

Twenty-one patients who received CRT and ≥2 doses of ipilimumab and 5 patients who received CRT only were evaluable for translational endpoints. Circulating T-cell subsets were evaluated by multiparameter flow cytometry. Cytokines were evaluated by multiplex ELISA. HPV-specific T cells were evaluated in a subset of patients by IFNγ ELISpot.

Expression of the activation markers ICOS and PD-1 significantly increased on T-cell subsets following CRT and were sustained or increased following ipilimumab treatment. Combined CRT/ipilimumab treaf antitumor immune cell function after primary CRT for this population at high risk for recurrence and metastasis. Several key immune biomarkers were identified that were associated with clinical response.Coronavirus disease 2019 (COVID-19) has fundamentally disrupted the practice of oncology, shifting care onto virtual platforms, rearranging the logistics and economics of running a successful clinical practice and research, and in some contexts, redefining what treatments patients with cancer should and can receive. Since the start of the pandemic in early 2020, there has been considerable emphasis placed on the implications for patients with cancer in terms of their vulnerability to the virus and potential exposure in healthcare settings. But little emphasis has been placed on the significant, and potentially enduring, consequences of COVID-19 for how cancer care is delivered. Abemaciclib In this article, we outline the importance of a focus on the effects of COVID-19 for oncology practice during and potentially after the pandemic, focusing on key shifts that are already evident, including the pivot to online consultations, shifts in access to clinical trial and definitions of “essential care,” the changing economics of practice, and the potential legacy effects of rapidly implemented changes in cancer care.