news roundup
The Synexus HealthyMinds Registry (HMR), a collaboration between Accelerated Enrollment Solutions (AES) – a business unit of CRO PPD – and the University of Exeter in the United Kingdom, has launched. This large U.S.-based research initiative is seeking 30,000 participants age 50 or older who do not have dementia. The five-year study will examine lifestyle and genetic risk factors impacting cognitive function over time to help identify ways to prevent and treat Alzheimer's disease and other forms of dementia.
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Elligo Health Research has partnered with Austin Cancer Center (ACC), an independent oncology group in central Texas and expands Elligo's Research Ready network to include its first oncology practice. ACC is currently enrolling patients for studies in breast cancer.
Appearing in the July/August Tufts CSDD Impact Report, the rare disease drug development has significant challenges for sponsors. For example, benchmark data from recent clinical trials show that, in addition to long study start-up and enrollment periods, screen and randomization failure rates are much higher in studies among rare disease patients.
Articles
In this article, the author explains new requirements for informed consent. For example, the Revised Common Rule now requires informed consent to begin with a concise and focused presentation of the "Key Information" that is most likely to assist a prospective subject or their legally authorized representative in understanding the reasons why they might or might not want to participate in the research.
In this Q&A, C.K. Wang, MD, senior medical director at COTA Inc., discusses challenges physicians face about oncology treatment options, and how RWE will help cancer patients and outcomes in the near future.
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