Featured Editorial
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TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability
3/20/2023
There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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Are Baseline Measurements Reliable? How RWD Can Help
3/6/2023
Baseline measurements presume to establish physiological and/or metabolic status before introduction of test drug(s). But what if they aren't truly reflective for a particular patient? Introducing real-world data (RWD) might be the answer for improved accuracy.
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Sites Look To Unravel The Tech Tangle Of DCTs
2/28/2023
Decentralized clinical trials and all their elements are touted as flexible options for patients. But what about the sites carrying them out? Jimmy Bechtel of the Society for Clinical Research Sites (SCRS) says sites are looking for clarity and consistency when it comes to the tech being thrust upon them by sponsors and CROs.
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Faster, Easier, and More Anxiety-Inducing: Are DHTs Harming Patients' Mental Health?
2/2/2023
Digital health technology (DHT) filled the communication gap created by physical distance during the pandemic, but have we created more space between participant and provider as we increasingly introduce and rely upon technology?
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The 3 Stages Of Decentralized Trial Maturity
2/1/2023
Decentralized clinical trials (DCTs) offer clear benefits to patients and the overall success of the trial, but it can be difficult to know how to address this challenge. This three-stage framework approach will enable you to assess your organization’s current clinical trial innovation maturity and build a plan from there.
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The 5Vs Of Collecting Clinical Data
1/26/2023
Not all data is created equal. Our data strategies need to be commensurate with the risks, complexity, and value of the data collected. If the true value of data is to be realized, it must be collected and captured in accordance with the five “V” dimensions: volume, variety, velocity, veracity, and value.
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How BMS Uses AI To Improve Study Design And Reduce Costs
1/19/2023
In 2022, Bristol Myers Squibb (BMS) announced plans to work with AI developer Owkin to design and optimize cardiovascular drug trials. The partnership will allow BMS to use machine learning to enhance clinical trial design and execution.
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Clinical Sites Are Optimistic, Despite Growing Challenges
1/17/2023
The last few years have not been easy for sites involved with conducting clinical research. The onset of the pandemic in 2020 created numerous challenges, including the implementation of new technologies and operating models, the leveraging of remote staff, and virtual facilities. Despite the ongoing challenges, global sites remain optimistic about the future of clinical trials.
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How Can Clinical Research Better Navigate Healthcare Deserts?
1/17/2023
Large swaths of the U.S. remain healthcare deserts, where access to clinical sites, pharmacies, and hospitals is limited. This contributes to underrepresentation in clinical research. What are the roles of technology and community outreach, and what are some current industry efforts to address it?