How primary care research can be improved in clinical practice? An Italian case study.

BACKGROUND: Primary care is considered essential for the sustainability of the Health System. Practice-Based Research Networks (PBRN) play a strategic role in translation of primary care research into practice. Research Capacity Building in primary care requires a improvement and development strategy and well-developed research infrastructures to support physicians. METHODS: We used the system development methodology referring to the Lean Thinking to create and support a research team in primary and pediatric care. In particular a "cascade" deployment model and the X-Matrix, a framework used in management studies to support strategy definition and management process. RESULTS: A research unit in primary and pediatric care has been created, by sharing vision, mission, core values, long-term strategies. The definition of a annual planning led to monitoring actions to guarantee the expected goals. CONCLUSIONS: Lean methodology is useful to adapt to various managerial and operational contexts, including healthcare. In our case it allowed team members to spread the culture of research, its importance and role to improve the health of patients, thank to the organizational support of a hospital IR, the Research and Innovation Department.

Brief Report: Canadian Cancer Trials Group IND.227: A Phase 2 Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma (NCT02784171).

Immune checkpoint inhibitors have activity in mesothelioma. IND.227 was a phase 2 trial (120 patients planned) comparing progression-free survival of standard platinum and pemetrexed (CP) versus CP + pembrolizumab (pembro) versus pembro. Accrual to the pembro arm was discontinued on the basis of interim analysis (IA-16 wk disease control rate). CP + pembro was tolerable, with progression-free survival similar between arms and median survival and overall response rate higher than those of CP alone (19.8 mo [95% confidence interval or CI: 8.4-41.36] versus 8.9 mo [95% CI: 5.3-12.8] and 47% [95% CI: 24%-71%] versus 19% [95% CI: 5%-42%], respectively). The subsequent phase 3 trial has completed accrual; results are expected in 2023.

[The organization and staff of a centralized Clinical Trial Center: the Alessandria model.] / L'organizzazione e il personale di un Clinical Trial Center centralizzato: il modello Alessandria.

The case study refers to the Clinical Trial Center (CTC) of the Public Hospital "SS. Antonio e Biagio and Cesare Arrigo" (AO AL) and the Local Health Authority of Alessandria (ASL AL), to which Clinical Research Coordinators (CRCs) and Clinical Research Nurses (CRNs) belong, unique in the regional panorama and a rarity into a public health organization not recognized as Scientific Institute for Research, Hospitalization and Healthcare (IRCCS).

Pilot Study to Evaluate Serum Soluble Mesothelin-Related Peptide (SMRP) as Marker for Clinical Monitoring of Pleural Mesothelioma (PM): Correlation with Modified RECIST Score.

A soluble mesothelin-related peptide (SMRP) is the only FDA-approved biomarker for diagnosis of pleural mesothelioma (PM) and the most used for monitoring treatment. Radiological assessment of PM, based on modified RECIST (mRECIST) criteria, is challenging. This pilot study was designed to evaluate whether SMRP levels correlated over time with mRECIST score. Serial serum samples from PM patients were collected and SMRP levels were measured and compared with the mRECIST score obtained through centralized CT scans by blinded review. The within-patient SMRP-mRECIST relationship over time was estimated through a normal random-effects regression approach applied to the log-transformed mRECIST score. Overall, 58 PM patients were included (46 males and 12 females) with a median age at diagnosis of 67 years (min-max = 48-79), 44 (76%) with epithelioid and 14 (24%) with non-epithelioid histology. The total number of SMRP measurements and CT scans considered for analysis was 183. There was a statistically significant correlation between SMRP and mRECIST score in the 2 cohorts considered both separately and jointly. These results, although exploratory, suggest that SMRP measurement might be considered as an adjunct to monitor PM patients in order to delay CT scans time interval, thus warranting further investigation.