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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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Reading Time: 2 minutes Sponsors know that access to compelling and relevant evidence across the experimental and real-world is crucial to drug development, safety monitoring, and the improvement of patient outcomes. Unfortunately, a data silo exists that results in loss of time, suboptimal insights, and an increased burden to sites, patients, and sponsors. The linking of clinical and real-world […]

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Reading Time: 2 minutesWhile decentralized clinical trials (DCTs) have provided benefits for participants such as fewer trips to trial sites and for sponsors, a huge increase in the amount and speed of data collected, they bring new risks due to the amount of data collected, digital endpoints, and the need to adjust oversight of compliance and data integrity. […]

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Reading Time: 2 minutesWorld Heart Day, celebrated annually on September 29th, raises awareness about cardiovascular disease (CVD) and its impact on millions of lives worldwide. Created by the World Heart Federation, this day unites people globally to promote heart-healthy living and reduce the risk of CVD. The heart is the body’s most powerful muscle, about the size of […]

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Reading Time: 3 minutesClinical trials are becoming more complex and a confluence of forces—including greater emphasis on patient experience, increasing protocol complexity, and precise value differentiation—is accelerating this complexity. Trials have evolved to include an ever-expanding array of data sources, increased data volume and precision, decentralized clinical trials (DCT), and adaptive designs. These environmental and industry changes have […]

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Reading Time: 4 minutes Clinical trials have evolved rapidly over recent years. They now have highly sophisticated protocols and multiple divergent data sources, inordinate data volume, decentralization, and increasingly complex adaptive designs. These changes have led to significant clinical data management challenges because the data management technologies and processes have not progressed at the same breakneck speed. Clinical data […]

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Reading Time: 3 minutesThe rising complexity of clinical trials has created great challenges to their traditional clinical data management process. These challenges present new obstacles to clinical data management, but they also create the opportunity to apply risk-based quality management (RBQM) principles to clinical data management. Risk-based clinical data management (RBDM) has been rapidly expanding over recent years. […]

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Reading Time: 4 minutesCollectively, more than 7,000 rare diseases are known to affect greater than 400 million people globally, and yet, a recent analysis found that only ~550 FDA approved orphan products are available to treat rare diseases. This is not surprising given that the pharmaceutical industry traditionally sidestepped rare disease drug development due to multiple known obstacles […]

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Reading Time: 2 minutes Gaps between clinical trial data (CTD) and real-world data (RWD) make it hard to fully understand long-term outcomes and therapeutic efficacy. Data linkage methodologies bridge these gaps. Data linkage lets sponsors link CTD with RWD at the patient level across current and completed trials—regardless of consent method—in a privacy-certified, CRO-agnostic manner while supporting multiple de-identification […]

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Reading Time: 2 minutesData linkage is a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data (CTD) with real-world data (RWD) at the patient level. Pharmaceutical companies seeking to build infrastructure for data linkage must make decisions early on to avoid pitfalls that can limit scalability and hinder evidence generation. In […]

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