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Reading Time: 3 minutesThe global pandemic has accelerated the adoption of hybrid trials. As sites and sponsors navigate the challenges of designing and implementing decentralized trials, this presents opportunities from a patient recruitment and retention standpoint. As we move towards a patient-centric clinical trial model, reducing patient burden through remote tele-visits is a major benefit. Now imagine this—the […]

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Reading Time: < 1 minuteMedidata and AbbVie Poster on Patient Dropout in Alzheimer’s Disease Clinical Trials at AAIC 2021 Patient dropout in Alzheimer’s Disease clinical trials is a very common challenge and can lead to trial delays, increased costs, and potentially biased trial results. In other studies, certain factors have been identified as influencing the risk of patient dropout, […]

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Reading Time: 3 minutesWritten in partnership with MIT Technology Review Real-world data has the potential to further refine the clinical trial process by making it faster, cheaper, and more accurate, and extending it to post-market surveillance to verify whether new medications and procedures fulfill the promise of their clinical trials. Medidata is exploring such possibilities with health tech company […]

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Reading Time: 3 minutesWritten in partnership with MIT Technology Review How does the U.S. Food and Drug Administration feel about external control arms? Favorably, though appropriately cautious, says Ruthie Davi, vice president of data science, at Medidata, who joined Medidata in 2016 after 22 years as an FDA statistician. She sees one of the best immediate applications in single-arm trials, […]

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Reading Time: 3 minutes Medidata Remote Source Document Review Feedback Although regulatory and industry adoption of remote source document review has been available for years, regulatory headwinds made adoption more difficult. In an effort to support clinical trial continuity during the COVID-19 pandemic, regulatory agencies, including the US FDA, embraced the adoption of the technology. In this post, we […]

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Reading Time: 5 minutesThe Clinical Financial Blog was created to address the complexities that are encountered with financial management of clinical trials. With a lot of critical financial requirements still not fully understood and addressed, we’ve got you covered. Medidata’s team of experts, who have lived and breathed the budgeting and site payments processes, will provide first-hand experiences, […]

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Reading Time: 5 minutesKelly McKee, Vice President of Patient Registries and Recruitment at Medidata, recently participated in a COVID-19 vaccine trial. Despite over two decades of experience in clinical trial operations and patient recruitment, this was her first experience as a patient. In this first-person blog, Kelly reflects on the many opportunities clinical trials still have to become […]

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Reading Time: 2 minutesWritten in partnership with MIT Technology Review External control arms have potential applications after regulatory approval of a product as well, says Ruthie Davi, vice president of data science, Acorn AI at Medidata. For example, once a treatment is on the market, insurance companies may want to compare it with other treatments for the […]

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Reading Time: 2 minutesWritten in partnership with MIT Technology Review Clinical trials have never been more in the public eye than in the past year, as the world watched the development of vaccines against COVID-19. Discussions of study phases, efficacy, and side effects dominated the news. The most distinctive feature of the vaccine trials was their speed. Because the vaccines […]

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Reading Time: 4 minutes Decentralized clinical trials (DCTs) have many benefits. DCTs accelerate clinical trial recruitment and patient enrollment, improve patient diversity, and increase medical research participation while decreasing patient burden through more options and greater choice. A range of data sources can be leveraged—traditional clinical data, data from wearable sensors, and patient-reported outcomes—making the outcomes more relevant and […]

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Reading Time: 6 minutesWomen in Clinical Trials – Overcoming a History of Bias and Exclusion Healthcare should be tailored to everyone, yet for decades medical research has largely overlooked nearly half of the global population. Women make up approximately 49.6% of the world’s population1, and according to the United Nations, this sex ratio is expected to become even […]

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Reading Time: 3 minutesThis blog was authored by Fiona Maini, Global Compliance and Strategy principal, Medidata, and Lauren Wheeler, Global Compliance and Strategy intern, Medidata. Women in Clinical Trials – Everybody Is Not the Same When It Comes to Biomedical Research Previously, we looked at the historical basis of women in clinical trials and the policies which […]

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