NCI Project
Mayo On Patient Primacy
The Mayo Clinic’s Jeff Sloan discusses where the field of patient-reported outcomes has come from and where it could be headed.
At its annual customer conference last week in its home town of Boston, PHT reviewed the last few years of growth in the electronic patient-reported outcome (ePRO) niche. Business has been good. The company says it is annually shipping 40,000-50,000 devices all over the world. Perhaps a third of all clinical trials, the company says, have a paper or electronic diary component. Now that electronic case report forms are standard, many sponsors are turning toward adopting electronic diaries. Recording subjective patient experiences on paper while gathering reams of other data electronically remains a common approach. But even slow-to-change sponsor firms are glimpsing the inherent absurdity and regulatory peril in such practices. But PHT also had a bit of actual news. The firm is working on adapting its ePRO software to run on devices other than the existing Palm and Microsoft mobile platforms, both of which are being warehoused by large, indifferent…more...
With the basic features and functions in place, many providers of clinical trial software are busy refining the ways that users get information in and out. Reports have been newly modernized…more...
Major electronic diary providers all built their platforms around a Windows or Palm-based device that plugs into an electrical outlet. But that dependence on hardware is a bit cloudy going forward,…more...
In this election season, there are too many unkind jokes about politics being the second-oldest profession. But that jesting got us to wonder. What is the second-oldest clinical trialPaper…more...
Safety. Efficacy. Are those two cardinal notions of clinical development enough? Jean Paty has a third. He believes it is as central as safety and efficacy. Paty is co-founder and senior VP of scientific, quality and regulatory affairs at invivodata, a Pittsburgh, Penn., electronic patient diary firm. If safety and efficacy are the X and Y axes…more...
Are patient-reported outcomes a growth industry? A business? Philadelphia's ERT apparently thinks so, having just paid $81 million for the clinical trial business of Carefusion. The purchase could increase ERT's revenue by 50 percent, to perhaps $150 million yearly. That would put it in the general ballpark of the sales at Parexel's technology division or …more...
After doing 20 trials together, Quintiles and ediary supplier invivodata announced a closer partnership. For the large contract research organization, the relationship likely brings additional scientific firepower to a research niche newly legitimized by a final FDA guidance document in patient reported outcomes (PRO). For the Pittsburgh ediary supplier, meanwhile, the relationship will bring more projects and…more...
The modern patient-reported outcome (PRO) study does not unfold in a vacuum. Whether launched via the web, a telephone interactive voice response system (IVRS), or a dedicated handheld device, most PRO projects rely on an army of external consultants and suppliers. Simple web- and IVRS-based PRO studies can handle only so much complexity, only so much branching…more...
The Mayo Clinic’s Jeff Sloan discusses where the field of patient-reported outcomes has come from and where it could be headed.
In the first of a ClinPage series, a sense of the centrality of the patient—and new levels of comfort with tools for electronic patient-reported outcomes (ePRO).
The technology firms have simplified the ways that customers can pass data from two systems to a third.
The Boston patient-reported outcome firm discusses ways to make running diary projects a bit easier.
The two Boston-area firms appear headed for a more intense IVR rivalry.
Rachael King, the new head of patient diary firm CRF, discusses trends and a robust pipeline.
From France, a hybrid system that uses special paper and a scanner-pen to gather clinical data.
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