Featured Clinical Leader Editorial
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Need To Clean Up Your Clinical Trials Budgeting And Forecasting Process? Try MOP-FACE
4/17/2023
Like the CTM who drinks CDER at the SPA without getting anyone SAD or MAD, our industry enjoys a good acronym. As such, here is the acronym to remember that will lead you to budgeting enlightenment: MOP-FACE.
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Why Developing A Metrics-Driven Culture Is A Clinical Operations Must-Do
4/14/2023
The number of systems used to support the conduct of clinical trials has increased and the amount of data used to monitor our portfolio, studies, and processes has soared. While there is still value in using traditional dashboards and reports, the use of advanced analytics and RWD/E is enabling us to ask more sophisticated questions to be more predictive — what will happen — and prescriptive — how to make it happen.
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What Core Outcome Sets Can Do — If We All Adopt Them
3/22/2023
A single trial provides just a snapshot of evidence. Many trials provide a summative account of how effective an intervention can be. But when the selected outcomes are different from trial to trial, it becomes much more challenging to reach a conclusion. Stuart Nicholls of the Ottawa Hospital Research Institute advocates core outcome sets as the remedy.
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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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Putting It Into Practice: Why We Need Embedded Clinical Trials
3/7/2023
Now is the time to embed elements of clinical trials within clinical practice, but why? Lindsay Kehoe of Clinical Trials Transformation Initiative (CTTI) explains the benefits to intertwining the two and offers ways to making it work.
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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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FDA Seeks Comment On Design And Data Considerations For Externally Controlled Trials For Drugs, Biologics
2/15/2023
On Feb. 1, 2023, the FDA released a new guidance, "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products," for public comment. It provides recommendations to sponsors and investigators, addresses considerations for the design and analysis of such trials, and more. Submit comments to the FDA by May 2, 2023.
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FDA Issues New Guidance On Dose Optimization For Oncology Therapies
2/9/2023
In January 2023, the FDA issued a new draft guidance document on optimizing the dosage of drugs and biological products for the treatment of oncologic diseases. Marjorie E. Zettler, Ph.D., MPH, executive director of clinical science at Regor Pharmaceuticals, summarizes its recommendations.
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Donating Surplus Clinical Trial Supplies Drives Pharma Sustainability Success
2/7/2023
Corporate sustainability efforts have been the hot topic since this decade began. However, some clinical operational professionals think that there's no place for sustainability in their role of conducting clinical trials. However, there is one simple way to implement a sustainability initiative within your organization's clinical trial conduct.
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How Flexibility Can Strengthen The Sponsor-Site Relationship
1/25/2023
In 2020, Freenome launched PREEMPT CRC to test the early diagnosis of colorectal cancer using a multiomics platform. Leveraging key soft skills like flexibility and respect for others' differences, Freenome successfully enrolled more than 40,000 patients across 200+ sites.