Andrew Barnhill, Head of Public Policy, Global Legal, IQVIAAlexandra Weiss, Director of Strategic Partnerships, Patient Advocacy Organizations, IQVIADiversity is paramount to the success of clinical research, both ethically and scientifically. Without adequate representation of…
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In June, the United States Supreme Court abandoned nearly 50 years of precedent and, for the first time in this nation’s history, eliminated a fundamental right: the right to choose. This decision, Dobbs v….
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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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February 14, 2023 – Health IT vendor Veradigm, formerly Allscripts, announced a collaboration with healthcare data ecosystem HealthVerity that will leverage registry data to advance chronic disease research. The partnership will bridge Veradigm’s cardiology and metabolic registries with consumer data collected by HealthVerity, offering clinical researchers access to research-ready data. The Veradigm Cardiology Registry boasts over 102 million patient records representing more than 19.9 million unique patients, making it one of the largest outpatient cardiovascular quality improvement registries. The registry follows cardiac patients over time, monitoring essential measures such as demographics, plan of care, cardiac events and comorbidities, exams, procedures, lab…
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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…
What Is Protected Health Information?According to UC Berkeley’s Human Research Protection Program, PHI includes any information found in medical records or clinical data sets that can be used to identify an individual. In addition, this information must have been collected, used or disclosed while providing a healthcare service. PHI can be used during the diagnosis or treatment of a patient or in clinical research processes.
The HIPAA Privacy Rule and Security Rule require the protection of identifiable health information, such as:
Information collected by doctors, nurses and other healthcare providers in the medical record
Conversations between doctors and other healthcare providers about a patient’s…
