Expert Insights On Decentralized Trials
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Decentralized Clinical Trials: Key Considerations For Sites & PIs
6/21/2022
As we work to harness the benefits of hybrid and DCTs, sites and investigators must have processes that allow for the acceptance of DCTs and successful implementation. As these policies are under development, the vital viewpoints of sites and PIs are largely overlooked. This article shares these vital viewpoints of sites and PIs.
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How To Navigate Drug Repurposing And Bridging Studies
6/17/2022
Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials.
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Best Practices For Designing Patient-Centric Decentralized Clinical Trials
4/12/2022
Decentralized clinical trials are not universally applicable to all phases of a trial and therapeutic areas. The recommendations in this article may bring decentralized and hybrid trials to a more tangible and realistic view and, in essence, make them more executable.
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2021 Clinical Research Site Survey Findings: A Year In Flux
3/24/2022
Since its inception in 2012, the Society for Clinical Research Sites (SCRS) has conducted an annual survey of clinical research site community members to derive insights, reveal trends, and ensure the site perspective is represented. This article summarizes the 2021 survey's findings.
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How To Turn Your Clinical Supply Chain Pandemic Learnings Into New Best Practices
3/10/2022
Pivoting, navigating, and problem solving in real time during the pandemic has led to many real-time lessons that have evolved into adapted best practices in the global clinical supply space. This article discusses the new demand curve, packaging operations, IRT considerations, and more.
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Trends In Decentralized Clinical Trial Remote Monitoring For Medication Adherence
2/23/2022
With the implementation of real-time remote monitoring technology, pharmas will be able to do more remote studies that require clinical trial patients to visit sites less frequently. This will remove the burden on patients and improve patient recruitment and retention. This article focuses on the patient medication adherence market.
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Patient Diversity In Clinical Studies: The Key To Advancing Precision Medicine
2/22/2022
Until we have better inclusion of participants with diverse demographics and behaviors – and can analyze that data – we won’t know the effectiveness of a product for these patients. This article shares the barriers to patient diversity in traditional studies, the efforts that the authors' company is putting forth, and considerations to keep in mind.
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Explosive Investment In Virtual Trial Companies: The Latest Data
1/20/2022
This article looks at the blossoming ecosystem and investment growth in the virtual trial space, specifically virtual trial companies that are foregoing the legacy clinical trial models and leveraging new technologies. Further, the article explores the power of the virtual trial platform and the key areas life sciences companies should consider when working with these virtual partners.
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Digitally Enabled Clinical Trials: A Practical Guide
12/2/2021
Undoubtedly, digital trials will stay as the world coexists with the pandemic, so it is essential for both sponsors and sites to be early adopters. This article will examine the benefits and challenges of digital clinical trials and identify key considerations for sponsors and sites as the world continues to navigate the new normal.
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Decentralized Clinical Trials: Data Considerations & Value-Added Taxes
11/23/2021
The rapidly changing regulatory, tax, and global business landscape, driven in part by COVID-19 and ongoing economic and political shifts, means that biopharma executives must keep careful watch over how they implement and monitor decentralized clinical trials (DCTs). This article examines key considerations for biopharma executives in overseeing hybrid or fully decentralized clinical trials.