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Clinical trials may benefit from new "app" technology.
Only two weeks before the FDA approved a mobile medical imaging application for the iPad and iPhone, Colin Miller, PhD, Senior Vice President, Medical Affairs for BioClinica, had his own first-hand imaging app moment. His sons were snowboarding six hours from home, when the call came that the youngest one was in the hospital with a fracture. Miller directed his eldest son to get the DICOM file of the clavicle fracture, decode it and e-mail it to a radiologist friend, who himself was traveling. Within moments, his friend relayed the severity of the fracture (not serious) after viewing the image on his iPhone. In the meantime, Miller and his wife made the drive more relaxed knowing that their son's prognosis was good. In fact, the friend confirmed the diagnosis from his full-screen computer the next day. The same findings as what he determined from the iPhone-viewed scan.
Miller was able to get a second opinion on his son's broken clavical remotely. (Source: Colin Miller)
Call it evolution and revolution, but there is a rapidity of events by which Miller discovered his son's diagnosis; followed by the FDA's approval of Mobile MIM for physicians to examine pictures from patient scans for computerized tomography, MRIs, and positron emission tomography scans; followed by a call Miller received from a company readying an app launch for the iPad and Android tablet systems for an EDC piece in the clinical trials space. "It's all happening so very quickly," noted Miller.
The FDA approved Mobile MIM for a 510(k) clearance on February 4, the first FDA approved diagnostic radiology application for mobile devices to allow physicians to view medical images on the iPhone and iPad. It is available now through the US Apple App Store, according to the company.
Mobile tech stats on usage in healthcare include: 72% of US physicians use smart phones, predicted to go up to 81% by 2012; and 22% of US physicians use iPads. These statistics were gleaned from a blog writer reporting from HIMSS the week of February 21. The blogger noted that the areas of growth for mobile healthcare included the Pharma/Clinical information systems piece for physicians. These findings bear up Miller's premise that the intuitiveness and ease of use of these tablets break down any previous technological platform barriers, especially among the technology-averse healthcare practitioner group. However, there remains the industry-specific barrier.
As is well-documented, and using EDC as an example, the pharmaceutical industry is itself not a fast technology adopter. Said Miller, "We drag along because of the regulatory requirements. And we're very poor on the technology uptake." It was only in 2008 that more than 50% of trials used EDC, but that has been slow going for close to 20 years.
But with the financial and development pressure pharma is under, the need to push to these technologies using wireless, broadband, and cloud computing for efficiencies may foster faster adoption rates.
"One of the historic challenges of data collection (using these technologies) is how to be sure it can't be hacked into," noted Miller when asked about the next set of challenges facing app development for clinical trials. "The human data in clinical trials and the problems of encryption and safety and security is the next nut to crack."
Miller is confident these challenges will be sorted out, and has reason to believe they will, based on recent conversations with app developers. Here are some real scenarios from John Rogue of New England Survey Systems that could mean the difference to this space: time to create CRFs, one day from two to three months; present number of queries 13,000 down to 17.
Explained Miller: "Of the top things that can really slow down a trial—protocol development, CRFs, drug supply, site enrollment, and IRB approval—you are only taking one item off the critical path (using above scenarios). But if you take out one, down to one day, your focus becomes much clearer and maybe you can reduce the others by half."
Miller outlines that many of these critical path items could easily be adapted for app use, to streamline the whole process. —Lisa Henderson