and mutation detection in circulating DNA from patients with metastatic colorectal cancer using BEAMing assay: Concordance with standard biopsy and clinical evaluation.

Patients with metastatic colorectal cancer (mCRC) are routinely screened for either - and to select the appropriate treatment. The present study aimed to evaluate the concordance between - and status in the tissue (either primary tumor or metastasis) and the plasma of patients with mCRC and to identify the associations between - and mutations in ctDNA and the clinicopathological parameters. Samples from a total of 31 patients with mCRC with measurable disease according to the Response Evaluation Criteria in Solid Tumors were analyzed.

Patient associations and clinical oncology research: how much does a patient's voice really matter?

: New trends are emerging in clinical research, such as patient empowerment and an active role in influencing health and research ethics. Patients' involvement is considered pivotal by stakeholders and institutions because they can channel the voice of those they represent, empowering their starring role in the different research activities.: To obtain an overview of the real involvement of Italian patient associations in clinical research.

Phase I studies: a test bench for Italian clinical research.

Background: The Agenzia Italiana del Farmaco (AIFA) Determination 809/2015 sets all the requirements that clinical units and laboratories must meet in order to conduct phase I studies. Requirements include buildings, equipment, personnel, emergency management, as well as quality requirements defined in a set of standard operating procedures.

Methods: In September 2018, the Italian Association of Medical Oncology working group, Clinical Research Coordinator, created an anonymous survey addressed to 51 medical directors of oncologic/hematologic clinical phase I units and all medical directors of generic and transversal units located in Italy and listed at the AIFA website.

Effect of Contract Research Organization Bureaucracy in Clinical Trial Management: A Model From Lung Cancer.

Introduction: Contract research organization (CRO) support is largely included in clinical trial management, although its effect in terms of time savings and benefit has not yet been quantified. We performed a retrospective multicenter analysis of lung cancer trials to explore differences in term of trial activation timelines and accrual for studies with and without CRO involvement.

Materials And Methods: Results regarding study timelines from feasibility data to first patient enrollment were collected from 7 Italian thoracic oncology departments.