The Apple iPhone broke new ground in offering an all in one device for Music, Phone, Games, Organizer and general applications. Other companies had introduced almost all the concepts. It was Apple that brought them all together so effectively.
I have considered the suitability of the iPhone specifically as a device for capturing clinical trial data. The obvious application is an eDiary device. People familiar with the iPhone will be aware of the phenomenal success of the App Store. It may be possible to write an eDiary app. However, there are challenges with metadata deployment and application patching that might prove insurmountable given the restrictions that Apple place in deployment. As far as using the native browser on the iPhone – the form factor is just not that suitable. Yes – you can fill in a browser based form, you can do the 2 fingered pan and zoom. But, it just doesn’t quite fly when it comes to regular data entry operations.
Shortly, Apple will release the iPad. In many ways this is like an iPhone or iTouch, but larger. Form factor wise, it is similar to many Tablet PC’s. However, it has the advantage of being tied to the iPhone/iTouch OS. It will also be provided with both Wifi and 3G connectivity.
One of the real boundaries to eSource in clinical trials is the portability and availability of the device at the appropriate times. With the larger touch screen of the iPad and the option of connectivity with either 3G or Wifi, it will be increasingly possible to efficiently capture data at the place of data availability.
So – could the iPad break the capture to paper / transpose to EDC bottleneck at the sites? I think so. The solution is likely to be browser based though – App deployment is still too restrictive. It needs to be fully touch screen friendly. It needs to make it beautifully easy for an investigator to ‘interview’ a patient, and key the data during the interview where appropriate. It needs to provide a means for the investigator to indicate through a simple highlighter pen style UI metaphor that data is being entered as source, or, being transposed from source.
I appreciate that other devices exist today that perform a similar function, but, I believe the connectivity, general ease of use, and low price point will make the iPad stand out.
One critical feature may be the Electronic Health Records link. I think the data that should be copied needs to be at the discretion of the site personnel. I am not yet convinced that data privacy together with a sponsor controlling the study build / data propagation is viable right now. A really simply copy/paste mechanism might be better than nothing in the time being. We will need to see how well the Safari browser performs.
Initially, I see the iPad making inroads within Phase I units. Hardware device interfacing is less of an issue here now – most devices should be looking at centralizing the data interchange, rather than sending it directly to the data entry device. Web 2.0 interactive technologies will allow developers to create some of the realtime functionality that dedicated Phase I solutions have enjoyed in the past.
I am looking forward to seeing the first iPad EDC demonstrations at the DIA in June!
4 comments:
I too have been intrigued since the release of the iPad in this arena, however it still doesn't answer the question of if an eCRF can be considered source? I can understand how it will allow the site to capture the eCRF data at time of subject visit, however its still not eSource. GCP's and SOP's still drive the "practice of medicine"; the protocol and the data being collected through the CRF is still a byproduct of source collected for the visit. The iPad may be a unique tool that gets us closer but i still feel that we are missing a lot before we classify it as eSource.
Many thanks for your comments.
Could I ask for clarification on your point that data entered at time of availability is not 'eSource'. If a Doctor takes notes during a assessment of a patient, and then records these notes into an electronic Patient Record system, is the Doctor required to file the paper notes in a binder for the patient?
If the Doctor - instead - uses an iPad to take notes, and then transposes these notes into the EPR, is that not eSource then?
The Practice of Medicine is the most critical aspect - above and beyond the study of drugs. However, provided the practice of medicine is not compromised and the data can be provided more rapidly, accurately and effectively for the study of drugs, is this not a better overall sitation for the patients in general? Are the GCP guidelines, and SOP instructions really doing their job in helping patients?
I disagree that app deployment need be too restrictive versus a browser based deployment.
The best implementation of the IPAD in EDC should not depend on uninterrupted WIFI or 3G connectivity to operate; lacking connectivity to operate, a native app is necessary. Yet, once a captured data file is uploaded, there must be a defined process for purging the mobile device.
We have implemented it(& more)and it is successfully in place today.
John,
I am not disagreeing with you here. Any iPad/iPhone app that successfully captures clinical trial data should operate online and offline. When a session goes online, it should intelligently deal with the synchronization of data and metadata. That part is not easy especially if you have offline changes to the metadata and duplication update collisions.
Regarding the limitations of Apps - I think these are being removed as the App platform matures. I am not an iP* App pro, but I suspect the platform available today could host both a traditional EDC tool as well as a patient eDiary.
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