Serppentino Weblog

SAS Reach Out for Wireless Application

Wireless clinical trial idea provailing. People have already thought about making use of SAS -- mainstream clinical trial data analysis software -- to accomodate wireless Electronic Data Capture activities. A SUGI (SAS User Group International) conference publication has research paper discussing the current development for SAS programs to interact with the EDC devices. Way to go wireless SAS!

Hurdles to Wireless Clinical Trials

Here is another talk about the brand new world of adopting wireless clinical trial technology and system, by Richard Hanscott, Vice-President of Business Solutions at Orange UK .

How far is it from reality? I can think about some immediate hurdles to it.

Data accuracy. patients or participants need to be trained and monitored at first to make sure the correct use of wireless monitoring devices. Some error may not be detected through a remote controling system, causing mistakes in the original data failure. also there are stringent requirement to the accuracy and reliability of the wireless monitors.

Safety and security in the process of data transmission. This is probably the most intriguing. A third party will be able (in theory) to capture the transmitted data, full of privacy and commercial secret.

Additional side effects to health from wireless data collecting and transmission. This could be an issue because unlike RDIF, these data need to be transmitted through fairly long distance, which requires more powerful device and stronger radiation signals.

A need to establish large scale EDC center for receiving, managing and distributing the clinical trial data, through wide geographic areas. This could well develop into a separate service or industry.

What else? I just can not think about one non-technology resistance to it. How soon can we expect one?

Wireless Clinical Trial Forerunners

First step towards wireless clinical trial

Several companies proposed the electronic clinical diary – or eDiary, device and services to approach to the ultimate goal of a fully wireless clinical trial. To list a few:

CRF, Inc, eDiray system   

Invivo data, invivodata system

Wireless Fantasy in Clinical Trial

11 –14 years. $800 mil. Is the average cost of R&D for a new drug to put on market for a pharmaceutical company. 70% of the R&D money goes to clinical trials.

Can wireless technology totally reshape the land?

Several series of wireless health monitoring device and systems are already on market. More are on the cue of FDA approval. They are – so far – all designed for individual patient use in hospitals and clinics.

Can we use then in clinical trials? I have been amazed by the thought. Phase III and IV clinical trials usually need to recruit hundreds to thousands of volunteer patients, monitor hundreds of health parameters including safety and drug efficacy, for a duration of several years. It should be a BIIIIIIIIIIIIIG development opportunity.

Picture this: clinical trial volunteers will no longer make frequent visits to the clinical trials sites and stay there for days, sometimes weeks. With devices brought back to home, all patients need to do is to wear the devices, take the pills, periodically drip some blood or urine samples to the device, and that’s all! All these can be done at home! With these done, data are transmitted directly to the Electronic Data Capture (EDC) service of the clinical trial, then data analysis services.

Further, with the proper monitoring system, in case any routine activity is missing – or certain data collection is missing, the clinical trial center may issue a (automatic?) phone call to remind the patients to take the drug, or take the measurements or tests.

Major human mistakes, that have been haunting the clinical trial workers all the time, will be gone! Missing data problems mostly gone! Difficulties in recruiting volunteers significantly reduced. Patient visits may be greatly reduced to only for important personal interact or only when complicated lab tests need to be done. Huge costs gone!

I googled for “wireless clinical trial”. Majority are the physician’s or companies collection for wireless data. At last I found one. A marketing analysis report talking about exactly what I have been thinking. Can$ 2650. If you are a developer seeking for new opportunity I fully believe its worthiness.

11 –14 years. $800 mil. Is the average cost of R&D for a new drug to put on market for a pharmaceutical company. 70% of the R&D money goes to clinical trials.

Can wireless technology totally reshape the land?

Several series of wireless health monitoring device and systems are already on market. More are on the cue of FDA approval. They are – so far – all designed for individual patient use in hospitals and clinics.

Can we use then in clinical trials? I have been amazed by the thought. Phase III and IV clinical trials usually need to recruit hundreds to thousands of volunteer patients, monitor hundreds of health parameters including safety and drug efficacy, for a duration of several years. It should be a BIIIIIIIIIIIIIG development opportunity.

Picture this: clinical trial volunteers will no longer make frequent visits to the clinical trials sites and stay there for days, sometimes weeks. With devices brought back to home, all patients need to do is to wear the devices, take the pills, periodically drip some blood or urine samples to the device, and that’s all! All these can be done at home! With these done, data are transmitted directly to the Electronic Data Capture (EDC) service of the clinical trial, then data analysis services.

Further, with the proper monitoring system, in case any routine activity is missing – or certain data collection is missing, the clinical trial center may issue a (automatic?) phone call to remind the patients to take the drug, or take the measurements or tests.

Major human mistakes, that have been haunting the clinical trial workers all the time, will be gone! Missing data problems mostly gone! Difficulties in recruiting volunteers significantly reduced. Patient visits may be greatly reduced to only for important personal interact or only when complicated lab tests need to be done. Huge costs gone!

I googled for “wireless clinical trial”. Majority are the physician’s or companies collection for wireless data. At last I found one. A marketing analysis report talking about exactly what I have been thinking. Can$ 2650. If you are a developer seeking for new opportunity I fully believe its worthiness.

HIPAA Compliance Source

Along with the proliferation of application of wireless technology in healthcare industry, including hospital and clinics, patient and facility management, healthcare management, and pharmaceutical, the security and privacy issue becomes growing concern. The most closely applied governmental regulation is Health Insurance Portability and Accountability Act (HIPAA). Here is a good source, a white paper discussing the major compliance issues, including design and security standards and solutions. Below is the major bullet points of the paper:

Steps to HIPAA Compliance

HIPAA Compliancy Certification

Establishing Wireless Security

Wireless LAN Standards

The NetMotion Solution

Military interested in wireless medical device

LifeWave Inc, a start technology company has received a $750,000 contract from military to develop a radar equipped badge that monitors the soldier’s heart function, so that the medics can find and treat the wounded soldiers on the battle field. LifeWave is also pursuing clinical trials for the civilian use of the badge, such as for the firefighters.

LifeWave is a startup company that mainly lives on private fund and angel investment. The founders believe that the market is huge, and the product has great impact in shaping the healthcare management.

There are several similar monitoring devices on the market, and still several pending FDA approval. LifeWave believes that there are still ample room for improvement, since current products on the market have effect issues, are too bulky, and don’t adapt to the environment very well.

PMP Wireless Healthcare System

Introducing a series of wireless medical device – PMS system from Card Guard.

The center of the system is PMP medical web center, which generates and manages electronic medical files for patients who are accessible from any handheld or PC browser. On the patient side, a series of portable or wireless devices monitor the important health measurements. Physicians receive such patient database containing medical files and test results.

A series of remote wireless monitors include wireless ECG, wireless blood pressure monitor, wireless blood glucose monitor, wireless spirometer, wireless oximeter and so on. After doing all the measurement, results will be displayed and saved on the PMP handheld device, and can be transmitted to the PMP Medical web center for physicians to access.

Bluetooth Cows

Wireless application on farmers -- A Danish vendor is developing a bluetooth mesh based system – for the cows. With sensors placed on each cow, the system can help farmers monitoring the location and health situation of their livestock.

The system is developed with corporations with the Danish Cattle Research and Danish Institute of Agricultural Science. The developer expect the to sell the system at less than 100 euro. It is expected that farmers with over 100 cows will benefit from buying the system. Original story comes from here.

Young Wireless Geek?

My 12 year old son’s middle school has received a donation – dozens of iBooks, that kids can sign out and use – to do projects and whatever they want. Result 1. I helped my kid to make a Powerpoint movie presentation for his science project, and he used HIS computer at school to display it. Result 2. He came to me and asked for one for him…what dja guys think about this marketing strategy? How old do you think is

Google China's Google Blackboard Newspaper Launched

Google China launched its official blog: Google blackboard newspaper.

People of at least my age from mainland China will understand the word “Blackboard Newspaper”. What about another even scarier word: “Big-character Newspaper”. Were they coming back? In the new era format – blogs? Yes and No. Yes, Chinese people are desperately trying to find channels to express themselves … nowadays they have it. No, gone is the time when some people can stirrup the craze and manipulate people's thought and actions -- for quite a long time, say 10 years -- for their own political (or other ) agenda. People blog for their own selves. Coming is the network era. Amid regulation, spying, filtering, censoring, we have it at last. Free at last.