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Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives
The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...
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How does an Early Feasibility Study differ from a Pivotal Study?
An Early Feasibility Study (EFS) is performed early in the device development process to evaluate the device...
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Hybrid Clinical Trials in the Age of COVID-19 and Beyond
We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
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Using Patient Preference Information (PPI) for Patient-Centered Medical Device Development
There is much interest in engaging patients in the medical device development process, at all stages of...
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Electronic Clinical Outcome Assessment (eCOA)
Electronic Clinical Outcome Assessment (eCOA) is a method of capturing outcomes data electronically in clinical trials. eCOA...
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Virtual Clinical Trials
New and refined technologies have allowed for novel data collection strategies in clinical trials. “Virtual” visits allow...
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Early Feasibility Studies
The EFS (Early Feasibility Study) process is a regulatory pathway created by FDA to facilitate the study...
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5 Reasons your Clinical Trial has Poor Patient Enrollment and Retention
Adequate patient enrollment and retention are absolutely essential to the success of a clinical trial. A study...
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Early Feasibility Studies (EFS) Program
The idea of the Early Feasibility Studies (EFS) program was first published in 2011 as a FDA...
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Clinical trials: considerations for designing and building an electronic data capture system (part 2)
Part 2: Considerations for designing an electronic data capture system for clinical trials with sponsors/CRO in mind....
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Clinical trials: considerations for designing and building an electronic data capture (EDC) system (part 1)
In clinical trials, electronic data capture (EDC) systems are widely used to collect data such as patient...
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Science of Patient Input (SPI): Part 3
Patient input into study design – participation considerations. The last, in a series about the science of...
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