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New opinions and trends in oncology PROs: Learnings from the 2022 FDA COA in cancer trials workshop

Clario

The FDA’s Oncology Center of Excellence (OCE) conducts annual public workshops on clinical outcome assessments (COAs) in cancer clinical trials. These workshops bring top leaders (and importantly, patient advocates) together for interactive conversations that seek to answer our most critical questions related to the use of patient reported outcomes (PROs) in oncology trials and to […]

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Clario finds patients are as compliant at home as on-site

Kelly Dumais, PhD – Senior Scientific Advisor  Our research shows that oncology clinical trial patients are just as compliant when completing patient-reported outcomes (PROs) at home as they are when completing PROs on-site. These findings demonstrate that at-home PRO completion is a viable method for oncology clinical trials, which we believe will help accommodate the […]

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FDA Draft Guidance Blood Pressure Monitoring in Clinical Trials – Questions Answered

Jeff Heilbraun, MS – VP Medical Affairs, Cardiac Safety Within the clinical trials arena, there are many references of blood pressure monitoring in protocols across all study phases and therapeutic indications. Blood pressure is often associated within a study’s schedule of events as a standard vital sign or safety assessment. Specific to the development of […]

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Creating hope, improving lives

Expressing gratitude for those who contribute to clinical research every day Lynne Borthwick – EVP and Chief People Officer at Clario Today is International Clinical Trials Day. For many people reading this, I’d guess this is news to you. For my colleagues at Clario and me, this is an important day because it celebrates the anniversary […]

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eDiaries: How often is too often?

Valdo Arnera, MD – eCOA Scientific Advisor Clario began using e-diaries in clinical trials nearly 25 years ago. During this time, two fundamentalquestions have continued to arise: How often should a questionnaire be completed by the patient? That is, how much can we reasonably ask of a patient daily? What about weekly or monthly? Too […]

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World Earth Day: Sharing our sustainability initiatives and joining the UN Global Compact 

Dr. Otis Johnson – Chief Diversity, Inclusion and Sustainability Officer at Clario Clinical trials save lives, so it’s easy to see the good that Clario’s work does simply in terms of the nature of the industry in which we operate. However, I see a broader responsibility for companies such as Clario. As a leader in our […]

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How to ensure lung safety is an important part of your trial protocol

Reza Farienfar – Vice President, Respiratory Solutions, Business Development Lung safety isn’t just a concern for classic respiratory conditions and rare diseases that directly affect the lungs. Many neuromuscular, autoimmune, and inflammatory conditions affect the respiratory system. For example, amyotrophic lateral sclerosis (ALS) causes damage to nerve endings that affect a patient’s ability to breathe […]

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Correcting course when eCOA endpoint collection runs into trouble

Shadi Zoghi, Vice President – Project Management at Clario Replacing a critical technology or services vendor during a study, such as an eCOA endpoint provider, is a difficult decision for a sponsor to make. Compounding the additional expense, logistical hassles, and re-training, the pharmaceutical company may lack confidence in the quality and accuracy of the […]

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How to improve respiratory data quality in non-respiratory clinical trials

Clinical trials that measure lung function ─ whether for respiratory or non-respiratory diseases ─ are among the most expensive to conduct. In such a competitive environment, it’s critical that trial sponsors capture the highest quality data from all patients in order to drive the success of the study and the overall development program. But the […]

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What is important to patients in oncology clinical studies?

Considering patient burden when incorporating patient-reported outcomes in oncology Kelly Dumais, Ph.D., Stephen Raymond, Ph.D. When measuring what is important to oncology patients, we must look beyond traditional endpoints to get a complete picture of treatment benefits. In recent years, there has been growing expectation that indicators like quality of life and disease symptoms be […]

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