#Clinical Trial


Rural areas, hit hard by COVID-19, lack access to new treatment trials

Three-quarters of rural Americans live more than an hour from the nearest site testing new treatments for COVID-19, research from the University of Virginia School of Medicine reveals. Overall, almost a third of Americans would have to travel more than 60 minutes to access new therapies as they are being tested.
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Clinical Trial of Frontline Trifluridine/Tipiracil Plus Bevacizumab Will Continue Despite Not Meeting Primary Objective Unresectable Metastatic CRC

Despite not meeting its primary end point of superior progression-free survival, the phase 3 SOLSTICE trial’s secondary end point analysis will continue in patients with unresectable metastatic colorectal cancer being treated with trifluridine/tipiracil and bevacizumab. Although the phase 3 SOLSTICE trial (NCT03869892) examining the use of frontline trifluridine/tipiracil (TAS-102; Lonsurf)...
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New evidence gives another option for Appendicitis

Appendectomy is one of the most common emergency surgical procedures in the United States. Now there’s mounting evidence some patients can avoid or delay removing the appendix and receive treatment with antibiotics instead. Five years ago, Heather VanDusen ended up in the emergency room at the University of Washington Medical...
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Erytech shifts focus to leukemia as lead drug flunks late-stage pancreatic cancer trial

After seeing an overall survival benefit in a mid-stage study of eryaspase in pancreatic cancer, Erytech Pharma likely thought a phase 3 would be in the bag. But the results are out (PDF) and the late-stage trial did not confirm the earlier result. The French biopharmaceutical company will now shift focus to developing the therapy in acute lymphoblastic leukemia, or ALL.
Business Insider

Pandemic-Driven Changes in Pharma Here to Stay as New Clinical Trial Models Take Hold

Did your organization implement new clinical trial methods during the pandemic? 84% surveyed said yes. "At the onset of the pandemic, the industry had to quickly adapt to keep trials afloat and this forced change helped researchers understand when and how to implement these approaches to improve clinical research," said Henry McNamara, senior vice president and general manager, Oracle Health Sciences. "Methods and technology that were being explored pre-pandemic have come front and center during the past 18 months. As clinical trials continue to evolve, study teams can rest assured that technology will help carry them into the future and speed new discoveries."

ERYTECH Pharma Stock Tumbles after Pancreatic Cancer Trial Disappoints — Shares of Erytech Pharma SA ADR (NASDAQ:ERYP) dropped 39% on Monday after it reported "disappointing" results from its Phase 3 clinical trial evaluating eryaspase as a treatment for pancreatic cancer. The company said the trial failed to meet its primary endpoint of overall survival in patients treated with...

Innovation Pharmaceuticals’ COVID-19 Clinical Trial Topline Results Anticipated to Be Reported the Week of November 8th (IPIX)

WAKEFIELD, MA / ACCESSWIRE / October 25, 2021 / Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced the Company anticipates reporting topline results the week of November 8th from its Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). The study data is presently blinded at the data management vendor, with final checks and approvals in progress.
Medscape News

Are "Healthy Volunteers" for Clinical Trials Actually Healthy?

More than a quarter of "healthy volunteers" who underwent screening for participation in a phase 1/2 clinical trial of a COVID-19 vaccine had at least one incidental finding detected. Additionally, a significant proportion of individuals practiced social habits that could be detrimental to their health. The results are from a recent study published in Clinical and Translational Science .

Insights into Definining Decentralized Clinical Trials

Dave Hanaman, Co-founder of Curavit, discusses his perspectives on decentralized clinical trials. Decentralized Clinical Trials (DCTs) have taken the main stage in the clinical trials industry, which was significantly facilitated during the pandemic. However, similar to the initiation of risk-based monitoring (RBM), the concept of DCTs is at an infancy stage, and many enterprises are competing to make their mark in the field. This prompted the formation of the Decentralized Trials & Research Alliance (DTRA) to help better define and advance DCTs. In this article, Dave Hanaman, Co-founder of Curavit, will discuss his perspectives on DCTs.

Simplifying safety reporting as part of clinical trial investigator retention

The pharmaceutical industry is like many others today in that there is a high turnover rate. The surge in new clinical trials starting and post-pandemic changes in hiring amplify these concerns for clinical investigators. For example, a 2017 study using the FDA’s Bioresearch Monitoring Information system classified 54.2% of principal investigators as “one-and-done,” meaning they had only ever worked on one clinical trial and were likely not interested in participating in another. That study surveyed 201 principal investigators (PIs).

Wilms Tumor Clinical Trial Insight, Pipeline Assessment, Companies, Emerging Drugs by DelveInsight

(Albany, US) DelveInsight has launched a new report on “Wilms Tumor Pipeline Insight, 2020″. “Wilms Tumor Pipeline Insight, 2020“ report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Wilms Tumor market. A detailed picture of the Wilms Tumor pipeline landscape is provided, which includes the disease overview and Wilms Tumor treatment guidelines.

OS Therapies doses first subject in Phase IIb osteosarcoma therapy trial

OS Therapies has dosed the first subject in the pivotal Phase IIb clinical trial of its lead therapy, OST-HER2 (OST31-164), to treat patients with recurred, resected osteosarcoma. An Lm vector-based off-the-shelf immunotherapy, OST-HER2 can potentially prevent metastasis, boost overall survival and delay recurrence. It acts on osteosarcoma in kids and...

Novartis’ antibody fails to meet primary goal in lung cancer trial

Novartis has reported that its antibody canakinumab (ACZ885) in combination with pembrolizumab plus platinum-based doublet chemotherapy failed to meet primary goals in the Phase III CANOPY-1 clinical trial in non-small cell lung cancer (NSCLC) patients. A human monoclonal antibody, canakinumab attaches to interleukin-1beta and hinders its interaction with receptors. The...

Advarra Announces Site IQ™ to Optimize Clinical Trial Feasibility

Site IQ™ is a new platform that leverages Advarra’s proprietary data resources and deep domain expertise to provide unique insights on clinical research site experience, capacity, quality, performance, and patient eligibility. Advarra, the market leader in regulatory review solutions, research quality and compliance consulting services and clinical research technology solutions,...

CytoDyn treats first subject in Phase III Covid-19 trial of leronlimab

CytoDyn has treated the first subject in the Phase III CD16 clinical trial of its chemokine receptor 5 (CCR5) antagonist, leronlimab, in critically ill Covid-19 patients in Brazil. An experimental humanised Immunoglobulin G4 monoclonal antibody, leronlimab attaches to CCR5. CCR5 is a cellular receptor vital in HIV infection, tumour metastases...