Clinical Trial Technology Editorial
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10 Years Of Progress In 10 Months: 2020 Was A Reset Year For Pharma
2/23/2021
A new report from McKinsey & Company highlights why 2020, despite the COVID-19 pandemic, was a banner year for innovation in drug development, and why we should be optimistic for the future of the industry.
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UCB Uses Decentralized Trials To Manage Studies
2/16/2021
UCB has a long history of conducting trials in immunology and neurology, with an emphasis in epilepsy. According to Tero Laulajainen, VP and head of global clinical science and operations for UCB, the company has a broad range of therapeutic expertise and numerous global trials, including studies in China. Therefore, the company expected to be impacted when news of the COVID-19 virus first began to make headlines.
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Is AI Improving Outcomes In Clinical Trials?
1/21/2021
In October 2020, I hosted a webinar on the topic of AI and how it will improve outcomes in clinical trials. This article highlights some of the comments from that discussion.
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Best Practices For Implementing Decentralized Clinical Trials
1/12/2021
While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.
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Pandemic Accelerates The Evolution Of Clinical Trials
1/7/2021
How much has the COVID-19 pandemic accelerated the evolution of clinical trials? A new report from Oracle Health Sciences and Informa Pharma Intelligence attempts to answer that question. The goal was to determine how the pandemic was changing clinical trial operations and identify the key challenges and opportunities surrounding those changes.
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#NoGoingBack Supports Keeping Patients First
1/5/2021
#NoGoingBack has been gaining a lot of attention of late. Founded by Signant Health and supported (and chaired) by industry leaders like Craig Lipset of Clinical Innovation Partners and Allyson Small of SCRS, the group has been pushing for permanent adoption of the trial changes implemented in 2020 to keep patients safe from COVID-19 and drive often-discussed innovation into standard trial practice.
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Tread Carefully Into Virtual Clinical Trials
12/21/2020
With the COVID-19 pandemic’s impact on clinical trials in the U.S. and around the world, everyone is suddenly focused on virtual (decentralized) clinical trials. But if you plan to move your trials to a virtual model, at least one industry executive is recommending that you use caution when doing so.
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X4 Pharma Adjusts Clinical Trials For A COVID World
12/17/2020
With the COVID pandemic afflicting patients around the world, those with a compromised immune system are at even greater risk. X4 Pharma is currently conducting a global Phase 3 trial that was underway when the pandemic hit, and is for patients who are immunocompromised.
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FDA’s Office Of Minority Health And Health Equity Addresses Patient Diversity
12/8/2020
The diversity of patients participating in clinical trials continues to be a problem in drug development. As sponsors and sites attempt to address the problem, regulators are also doing their best to address the issue. One person deeply involved in this issue is Rear Admiral Richardae Araojo, the associate commissioner for minority health and director of the Office of Minority Health and Health Equity at FDA.
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New Approaches In Patient Tracking For The Rare Disease Sector
11/17/2020
While we have seen exponential growth in the effort to develop drugs to treat rare diseases in the 30 years since the Orphan Drug Act was introduced, unique challenges remain. Awareness of rare diseases is often low among stakeholders including physicians, healthcare providers, payers, and even patients themselves; trial protocols and regulatory pathways may be unclear, especially for investigational rare disease drugs that are first-in-class; and data on disease incidence, onset, progression, and burden are often limited.