5 Components of a Patient-Centric eCOA Strategy for Oncology Clinical Trials

5 Components of a Patient-Centric eCOA Strategy for Oncology Clinical Trials

Melissa Mooney, Director of eCOA Solutions Engineering at IQVIAIn the US alone, an estimated 1.9 million new cases of cancer were diagnosed in 2022, positioning oncology as a key subject of clinical research. Throughout oncology trial development, it is important that stakeholders acknowledge that only patients can fully understand the impact of treatment on their lives. Regulators are now looking beyond clinical indications such as tumor size and delayed disease progression. When evaluating the risks and benefits of treatment, they want to know whether the side effects are tolerable for patients and how these treatments could be improved from the patient’s…

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HIMSSCast: Epic leaders on data-driven clinical trial innovation

HIMSSCast: Epic leaders on data-driven clinical trial innovation

The challenges of designing effective clinical trials, finding the right people to participate in them and building trial cohorts that are representative of the population at large, have been well-documented.With its recent Life Sciences initiative, Epic has set its sights on data-driven insights to improve the development of new therapeutics and interventions. That includes improving all parts of the clinical trial process – from how physicians educate their patients about potential cohorts, matching and connecting patients with promising research and helping make sure those studies are optimally beneficial for as many people as possible. Epic is already helping its provider customers…

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Cell Therapy Biotech Talaris Ends Two Kidney Transplant Trials, Restructures

Cell Therapy Biotech Talaris Ends Two Kidney Transplant Trials, Restructures

Talaris Therapeutics aimed to transform solid organ transplants with a cell therapy that replaces anti-rejection drugs patients need for the rest of their lives. But after clinical trial setbacks, the biotech has decided to end two kidney transplant studies. Although a separate test of its experimental therapy is continuing in a rare autoimmune condition, Talaris has commenced a restructuring plan that it said could culminate in a merger or sale of the company.
The restructuring announced Thursday will lead to the layoff of about one-third of Talaris’s staff. As of the end of the third quarter of 2022, the Louisville, Kentucky-based biotech…

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Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

What You Should Know:– Deloitte Centre for Health Solutions releases its thirteenth annual report, ‘Seize the Digital Momentum: Measuring the return from pharmaceutical innovation 2022’ that explores the performance of the biopharmaceutical industry (bio Pharma) and its ability to generate returns from investment in innovative new medicines.– Since 2021, much of the world has successfully adjusted to life where COVID-19 is more endemic as vaccines and treatments reduced the risk and severity of illness, however geopolitical turmoil and a global cost-of-living crisis have continued to drive serious instability in the health landscape.Pharmaceutical Innovation – Trends and Insights At a GlanceThis is…

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Heartpoint Global Hopes To Disrupt Congenital Pulmonary Hypertension Treatment With Minimally Invasive Device

Heartpoint Global Hopes To Disrupt Congenital Pulmonary Hypertension Treatment With Minimally Invasive Device

To correct high blood pressure of the pulmonary artery, which can arise from congenital defects of the heart, an artificial heart ucan cost upwards of $190,000. Heart disease accounted for about one in five deaths in 2020 in theUnited States.
Even minimally invasive pulmonary artery banding — a surgical technique that has been in use since Harry Truman was president — requires access to the chest cavity. A new treatment under development by HeartPoint Global seeks to provide a minimally invasive alternative to current treatments for pulmonary arterial hypertension associated with Congenital Heart Disease.A device delivered through the leg would cost only…

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Where Are All the Patients?

Where Are All the Patients?

It’s no secret that patient enrollment is one of clinical research’s biggest hurdles. According to an analysis of trials listed, 55% of terminated trials were ended because of low patient enrollment. The analysis also reported that Phase III and Phase IV trials have an enrollment efficiency of less than 40%. Yet another analysis found more than 80% of studies do not enroll on time, often leading to a study extension or additional research sites.
The problem isn’t just enrollment, it’s also the enrollment of diverse patients. Racial and ethnic minorities, specifically Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native…

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Adverse Survival Signal Leads G1 to Stop Pivotal Test in Colorectal Cancer

Adverse Survival Signal Leads G1 to Stop Pivotal Test in Colorectal Cancer

G1 Therapeutics’ approach to cancer does not kill tumors. Instead, the biotech’s drug, trilaciclib, protects bone marrow from the damaging effects of chemotherapy, reducing the duration and severity of the problems that can limit the use of this cancer treatment. Since trilaciclib’s initial approval insmall cell lung cancer, G1 has pursued more clinical trials that could support expanding the drug to other cancers. Colorectal cancer will no longer be one of them.
On Monday, G1 reported preliminary data showing that the placebo group outperformed the trilaciclib arm in helping patients live longer. G1 said it has decided to stop the colorectal cancer…

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