The Competency of Clinical Research Coordinators: The Importance of Education and Experience.

Background: The organization and operation of clinical trials have become increasingly complex requiring the coordination of a well-trained workforce to ensure that complicated protocols yield valid results that will advance human health. We hypothesized that formal education in clinical research is equivalent to a number of years of work experience as a clinical research professional in terms of self-perceived clinical research competence.

Methods: Using REDCap, we conducted a survey of students and recent graduates from academic programs in clinical research in the USA using the CICRP index that consists of 20 clinical research core competencies.

Adjunctive homeopathic treatment of hospitalized COVID-19 patients (COVIHOM): A retrospective case series.

Background: and purpose. COVID-19 is a novel viral disease causing worldwide pandemia. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to hospitalized patients with confirmed symptomatic SARS-CoV-2 infection.

A Phase II Study of Durvalumab in Combination with Tremelimumab in Patients with Rare Cancers.

Lessons Learned: Disease control with signals of response were demonstrated, which should lead to future validating clinical trials using checkpoint inhibitors in this underserved rare malignancy population. Although the study of single types of rare cancers is practically challenging, clinical trial designs that aggregate such patients into cohorts treated similarly are feasible, even in the community setting.

Background: Patients with rare cancers are an underserved population with limited access to clinical trials aside from phase I trials in the refractory setting.

Efficacy of therapeutic plasma exchange in the treatment of penn class 3 and 4 cytokine release syndrome complicating COVID-19.

Objectives: Cytokine release syndrome (CRS) is a potentially severe complication of COVID-19 most commonly resulting in respiratory failure. This ten-patient study was designed to determine the efficacy of therapeutic plasma exchange (TPE) in improving oxygenation and in reducing the cytokine load in a critically ill subset of patients.

Methods: Five single volume plasma exchanges over eight days within a 14-day study period.

Leveling the Joint Task Force Core Competencies for Clinical Research Professionals.

Competency standards for clinical research professionals are being developed across the enterprise, based largely on the Core Competency Framework put forth by the Joint Task Force for Clinical Trial Competency (JTF). In late 2016, representatives from organizations around the world convened at a workshop hosted by the Multi-Regional Clinical Trial Center of Brigham and Women's Hospital and Harvard (MRCT Center) to discuss their use of the standards. A number of modifications were suggested that resulted in the publication of JTF Framework 2.

Phase 1 study of the MDM2 inhibitor AMG 232 in patients with advanced P53 wild-type solid tumors or multiple myeloma.

Background This open-label, first-in-human, phase 1 study evaluated AMG 232, an oral selective MDM2 inhibitor in patients with TP53 wild-type (P53WT), advanced solid tumors or multiple myeloma (MM). Methods In the dose escalation (n = 39), patients with P53WT refractory solid tumors enrolled to receive once-daily AMG 232 (15, 30, 60, 120, 240, 480, and 960 mg) for seven days every 3 weeks (Q3W). In the dose expansion (n = 68), patients with MDM2-amplified (well-differentiated and de-differentiated liposarcomas [WDLPS and DDLPS], glioblastoma multiforme [GBM], or other solid tumors [OST]), MDM2-overexpressing ER+ breast cancer (BC), or MM received AMG 232 at the maximum tolerated dose (MTD).

Phase I studies of interleukin (IL)-2 and rituximab in B-cell non-hodgkin's lymphoma: IL-2 mediated natural killer cell expansion correlations with clinical response.

Purpose: Expansion and activation of natural killer (NK) cells with interleukin-2 (IL-2) may enhance antibody-dependent cellular cytotoxicity (ADCC), an important mechanism of rituximab activity. Two parallel Phase I studies evaluated combination therapy with rituximab and IL-2 in relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).

Experimental Design: Thirty-four patients with advanced NHL received rituximab (375 mg/m(2) i.

Phase II trial of piroxantrone in gastric carcinoma. A Southwest Oncology Group study.

Twenty-one evaluable patients with advanced gastric adenocarcinoma were treated with piroxantrone at a dose of 150 mg/m2 intravenously every 21 days. One objective response was seen for an overall response rate of 5% (95% confidence interval 0-24%). Toxicities of grade > or = 3 were primarily hematologic and seen in 13/21 patients.

Thyroid and parathyroid cancer.

The epidemiology, etiology, pathology, and management of thyroid and parathyroid carcinoma are discussed. Emphasis is placed on the clinical differences in the management and treatment of the various histologic subtypes of thyroid cancer. The biologic and prognostic differences among the various histologic types of thyroid cancer and their relationship to age are stressed.

Thyroid and parathyroid cancer.

The epidemiology, etiology, pathology, and management of thyroid and parathyroid carcinoma are discussed. Emphasis is placed on the clinical differences in the management and treatment of the various histologic subtypes of thyroid cancer. The biologic and prognostic differences among the various histologic types of thyroid cancer and their relationship to age are stressed.

1 alpha,25 Dihydroxyvitamin D3 and mononuclear phagocytes: enhancement of mouse macrophage and human monocyte hydrogen peroxide production without alteration of tumor cytolysis.

1 alpha,25 dihydroxyvitamin D3 (1,25 D3) is known to interact with hematopoietic cells. The purpose of this study was to determine the effect of 1,25 D3 on hydrogen peroxide (H2O2) production and tumor cell killing by mouse peritoneal macrophages and human blood monocytes. Enhanced monocyte and macrophages phorbol myristate acetate (PMA)-stimulated H2O2 production was observed at concentrations of 0.

Acute myeloblastic leukemia in paroxysmal nocturnal hemoglobinuria. Evidence of evolution from the abnormal paroxysmal nocturnal hemoglobinuria clone.

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired hematopoietic stem cell disorder in which the blood cells demonstrate aberrant interactions with serum complement. In part, this is due to the absence of the complement regulatory protein, decay accelerating factor (DAF). A small number of patients with PNH have gone on to develop acute nonlymphocytic leukemia, which is thought to arise from the injured marrow as a second hematopoietic disorder.

Isolated anterior chamber relapse in acute monoblastic leukemia.

A case of acute monoblastic leukemia relapsing in the anterior chamber of the eye is described. Despite rigorous evaluation, no systemic or central nervous system involvement was detected. All previously reported cases of anterior chamber infiltrates in AML have had coexistent systemic or central nervous system disease.

Acute lymphoblastic leukemia of Burkitt's type (L3 ALL) with 8;22 and 14;18 translocations and absent surface immunoglobulins.

A 57-year-old woman presented with L3 acute lymphoblastic leukemia demonstrating typical Burkitt's type morphology. Cytogenetic analysis revealed one of the variant translocations seen in Burkitt's lymphoma [t(8;22)] and a 14;18 translocation. Surface marker data at presentation and at autopsy demonstrated several B-cell markers, but absent surface immunoglobulins.

Radiologic manifestations of small-bowel toxicity due to floxuridine therapy.

Floxuridine (5-FUDR) is an antipyrimidine used in the treatment of metastatic colorectal carcinoma. Bowel toxicity, manifested predominantly by diarrhea and abdominal pain, is one of the main complications of 5-FUDR therapy. Six patients who had received 5-FUDR infusion either by hepatic arterial or systemic intravenous routes subsequently developed severe diarrhea and were evaluated by small-bowel series.

A reversible enteropathy complicating continuous hepatic artery infusion chemotherapy with 5-fluoro-2-deoxyuridine.

This article describes two patients with hepatic metastases from colorectal cancer in whom a reversible enteropathy developed during the administration of hepatic artery infusion chemotherapy with 5-fluoro-2-deoxyuridine (5-FUdR) via an Infusaid Series 400 pump (Infusaid Corp., Sharon, MA). Both patients had severe diarrhea and signs that suggested small bowel obstruction.