Considerations on the use of Mobile eCOA/ePRO Technology in Clinical Trials

I’m going to be providing this training internally at my company. I’m wondering if it is of interest externally as well….

The use of Electronic Clinical Outcome Assessments (eCOA) or Electronic Patient Reported Outcomes (ePRO) via mobile devices (smart phones, tablets, etc.) has been evolving and expanding in recent years. As an industry, we’ve conquered some of the early challenges experienced with the use of these devices in the clinic, usually on lower risk data and often with a paper backup process in place. However, as we move forward with increasingly complex devices and data collection schemas for higher risk efficacy/safety data the stakes have raised. Adding to this risk is the advent of adaptive trial design and increased time pressures in clinical research. New challenges have emerged that need to be considered and mitigated as we move forward with the promise these technologies hold in the improvement of trial design and data quality. This training is designed to enhance the understanding of professionals in all areas of clinical research (Clinical Operations, Monitoring, Clinical Scientists, Data Management, Biostats, Medical Writing, etc.)  and the service organizations that support them (IT, Procurement, Contract Management, Quality, RA, Safety, etc.) including Senior Leadership who drive the initiatives to adopt best-in-class tools and design.

Thoughts?

~TJK

 

Novartis goes digital with FocalView for ophthalmology clinical trials

(Image: Getty/demaerre)May you live in interesting times… A colleague flagged this for me. I’ll be very interested in the particulars of how this all works going forward. #ItsAllAboutApps

 

~TJK

Source: Novartis goes digital with FocalView for ophthalmology clinical trials

Safety Communications > Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication

As a heart patient myself, I’m intrigued by the cyber-security aspects of these implantable devices. I think we’re going to see a lot in this area in the short-term.

~TJK

“Cybersecurity

Many medical devices—including Abbott’s ICD and CRT-D devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.”

Source: Safety Communications > Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication

Vaccines, Real Medicine

I’m so tired of #Homeopathabullshit….

~TJK

LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network : The Two-Way : NPR

On security…

LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network

Updated February 18, 201610:36 AM ET
Published February 17, 20169:08 PM ET
LAURA WAGNER
The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.
The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.

A Los Angeles hospital paid a nearly $17,000 ransom to hackers who breached and disabled its computer network, the hospital said in a statement LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network

The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.
Junkyardsparkle via Wikimedia Commons
A Los Angeles hospital paid a nearly $17,000 ransom to hackers who breached and disabled its computer network, the hospital said in a statement Wednesday…

Mobile Devices in Medicine

There’s been a lot of interest in expanding the use of mobile electronic devices as a part of medical treatment. They’ve been in use in clinical trials (for Patient Reported Outcomes, or ePRO) for years starting with Palm Pilot devices with both good and bad results. A lot has been learned in that time; security and data integrity safeguards are improving. However, as devices get more powerful and more complex, new issues are being discovered…..even in the “Apple Magic Bullet” that is touted (and marketed) as being superior on that front. Case in point (Click Link for Full Article):


Germany warns of Apple security problem

By JUERGEN BAETZ, Associated Press Writer – 04 AUG 2010
BERLIN – Several versions of Apple’s iPhone, iPad, and iPod Touch have potentially serious security problems, a German government agency said in an official warning Wednesday.
Apple’s iOS operating system has “two critical weak points for which no patch exists,” the Federal Office for Information Security said.
Opening a manipulated website or a PDF file could allow criminals to spy on passwords, planners, photos, text messages, e-mails and even listen in to phone conversations, the agency said in a statement.
“This allows potential attackers access to the complete system, including administrator rights,” it added, urging users not to open PDF files on their mobile devices and only use trustworthy websites until Apple Inc. publishes a software update.

There’s enormous opportunity with new technologies, but a profround responsibility to be diligent in assessing them and protecting their data.

~TJK

New Drug Development – 1.5 Billion Dollars

I was sad (though not surprised) to hear of JnJ’s pending layoffs. I have friends who work there. However, the thing that really caught my attention in this article is that the cost to develop a new drug has moved from US $800 Million to US $1.3-1.5 Billion in just a few years. I don’t have a lot of time to expound on this, but thought it worth flagging.

~TJK

J&J to slash 7,000 to 8,000 jobs

By Ransdell Pierson –

NEW YORK (Reuters) – Johnson & Johnson plans to cut up to 7 percent of its workforce in order to generate cost savings needed to finance increasingly costly drug research and to weather future challenges, the diversified healthcare company said on Tuesday.
J&J said the planned restructuring will eliminate 7,000 to 8,000 jobs and generate annualized cost savings of $1.4 billion to $1.7 billion by 2011…..[snip]

The typical cost of developing a new medicine has now climbed to between $1.3 billion to $1.5 billion, from a cost of $800 million only a few years ago, Weldon said. He noted that J&J and other drugmakers increasingly are partnering with rival companies in order to share such financial gambles…..[snip]

Defending Pharma

As all of the discussion on Healthcare reform comes to a head, I think it warrants some comments from me regarding “The Greed of Pharma”.  Let me start by saying that Pharma is a for-profit business like any other.

I think it is important to note that neither pharma (nor the insurance industry for that matter) has particularly high profitability (ROE %’s). The following industries have a higher ROE % (Return on Equity rating) than Pharma (21 of them, and in the order listed). Cigarettes has nearly triple Pharma’s profitibility (and the US Gov is a de facto share holder); Aerospace has double. So why would Pharma be expected to foot the healthcare bill (and squeal like a pig -to paraphrase Congressman Marion Berry of Arkansas) when there are so many other more deserving candidates?

 

Cigarettes

Aerospace/Defense – Major Diversified

Information & Delivery Services

Diversified Computer Systems

Cleaning Products

Beverages – Wineries & Distillers

Processed & Packaged Goods

Auto Parts Stores

Education & Training Services

Application Software

Personal Services

Food Wholesale

Industrial Metals & Minerals

Restaurants

Gas Utilities

Management Services

Personal Products

Personal Computers

Agricultural Chemicals

Diversified Communication

Electronics Stores

 

~TJK

Fundamentals of Quality

I’ve gotten some questions of late that have had me thinking about the core of what I do; fundamental questions as to what it is and why. This is a good thing and I feel that now is a good time to till this fertile soil and see what can be learned (or remembered).

Over the next few weeks, I plan to explore these ideas in a series of posts. I’m planning on submitting an abstract or two to the SQA conference and this will be a good stepping-off point to get that effort underway. I plan to present on a subfield in which I am working very heavily in my current role; Clinical System Validation. That is, Computer System Validation for the Clinical (GCP) arena within the greater pharma landscape (pharma, medical devices, and related industries).

In any case, its been too long since I’ve added some really good content here. Keep your fingers crossed that I’ll be able to put up something useful, interesting, or both.

~TJK

NYC Half-Marathon

I was asked to post this advert for the NYC Half-Marathon to benefit the Freshair Children’s Charity. This seems like a worthwhile thing to do.

SubscribeToNYCVolunteerNewsletter

The Fresh Air Fund is still looking for runners and sponsors to join our Fresh Air Fund-Racers team for the NYC Half-Marathon on August 16th. It would be a huge help if you could post a mention of this exciting news on T.J. Kuhn’s GxP Zone. This is a great way to participate in NYC’s premier summer road race while helping Fresh Air Fund children. Please feel free to use anything from our site here:

http://freshair.org/racers

Last summer’s NYC Half-Marathon was a huge success and the Fresh Air Fund-Racers raised more than $125,000. We are also still in need of Friendly Town hosts for next month. Host families open their hearts and home to a NYC child who would not otherwise have the opportunity to escape the hot, crowded city streets. Please let me know if you are able to post or have any questions, and if you could send me the link that would be fantastic.

Thank you so much,

Sara


Sara Wilson,
The Fresh Air Fund
http://www.freshair.org

~TJK