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

 

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A Summary of the New MHRA ‘GXP’ Data Integrity Guidance and Definitions – March 2018

A Summary of the New MHRA ‘GXP’ Data Integrity Guidance and Definitions – March 2018

For over 20 years, there have been Health Authority regulations governing the use of Electronic Records and Electronic Signatures (eReS) for GxP purposes. These regulations (the US part 11, the EU Annex 11, and their ilk globally) are arguably among the most elegant, concise, and consistent across jurisdictions (with differences mostly limited to context and emphasis rather than substance).

That being said, there has been a considerable amount of confusion in interpreting and applying the eReS regulations as both the Regulators and those in Industry have evolved their understanding of these regulations as the various guidance documents have emerged, been rescinded, revised, re-issued, clarified, etc.

This latest guidance document (which can and should be read in its entirety here (21 pages): https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHR), is very mature in its outlook and takes what has come before and builds upon it. The result adds a huge amount of clarity by specifically expounding on the general theme “This what we want, yes it means exactly that, and yes we understand the practical considerations and resource impact of what we want”.

Some key items in the guidance include:

• Its application is intended across all GxP areas (Excepting Medical Devices – which I found interesting)
• The principles of data integrity (which are separate from those of data quality) are meant to be adaptable, and are designed to evolve with Technology and promote a risk-based approach.
• The non-technical aspects of data integrity are addressed, including the organizational responsibility to create a culture and environment (controls) that ensures that data is complete, consistent, and accurate in all forms (They focus on the oft neglected idea that PEOPLE are part of the process).
• They revisit both ALOCA and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available. They go on to clarify that these two acronyms are differing ways of explaining the same expectations.
• Differing paper, electronic, hybrid scenarios are discussed as are the ideas around Risk, Risk mitigation, and documentation around both. Warnings are made about poor organizational controls and the over-reliance on a system’s validated state.
• Challenges and considerations around designing data processes and controls are discussed in some detail.
• Key definitions are explained in some detail for: Data, ALCOA, Raw = Source Data, Metadata, Data Integrity, Data Governance, Data Lifecycle, Recording & collection of data, Data transfer & migration, Data Processing, Data Exclusion, True Copy, Transactional data, Audit Trail, Reconstructability, Electronic Signatures, Data review and approval, Data Retention/Backup/Archival, System Access, the Admin Role, Validation, and IT Suppliers including Cloud providers).

~TJK

Data firm at center of Facebook privacy scandal will close

I think this was all but inevitable….

~TJK

Source: Data firm at center of Facebook privacy scandal will close

Novartis goes digital with FocalView for ophthalmology clinical trials

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

The Golden State Killer Is Tracked Through a Thicket of DNA, and Experts Shudder – The New York Times

The Golden State Killer cold case begin cracked via information submitted to an online genealogy DNA database opens up a new dialog on privacy, DNA, and sharing….

~TJK

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

Alexa, Fitbit and Apple Watch are your digital snitches – CNET

Alexa is always listening…..

~TJK

 

Source: Alexa, Fitbit and Apple Watch are your digital snitches – CNET

WEARABLE TECH

Your Alexa and Fitbit can testify against you in court

In today’s digital world, Big Brother may be on your wrist, in your room — or inside your heart.

BY 

• MARGUERITE REARDON

APRIL 5, 2018 5:00 AM PDT

reMarkable Tablet

Hi REMARKABLE eWriting Tablet Thingie people,

I’m very impressed with the concept and initial execution (you’ve shipped a viable product….Bravo!). That being said, there is a lot of promise here (untapped promise). Things like OCR, indexing, interfaces to external apps, an embedded web browser (even if only text), etc. etc. etc. There are so many ways you could go with this.

 

Is there a road map as to where you *actually are going* (or attempting to go). Not just exploring your options, but going with intent. I know that you don’t promise anything that you’re not sure of, but give us an idea. Is there a document online outlining this?

 

Before I drop $500+ on a tablet of this sort that only does some of what I’d need to ditch my paper notebooks, I’ll want to know what to a bit about the plan. Will earlyadopters be rewarded or will they be left holding a pricey beta device once the more polished/functional version comes out in 6 months or a year? Thanks and keep up the good work.

 

~TJK

Open Source

The open-source model has been crucial…and this article outlines that nicely.

 

Mozilla’s radical open-source move helped rewrite rules of tech

A gamble 20 years ago unleashed the source code for the browser that became Firefox. The approach is now core to Facebook, Google and everyone else.

New Proposed Auditing Course: Considerations for an eData Quality Audit Program

We’ve submitted this course proposal for the April SQA Quality College in Anaheim. Feedback has been good, but even if it isn’t picked up for this venue…it will eventually happen *somewhere*:

Instructors: Timothy J. Kuhn and Conrad Kawaguchi

Target Audience: Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.

 Course Objectives

• Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.

• List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)

• Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)

• Define and list the desired skill set for the eData Audit Team

• Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes – AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.

Course Description: Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT saavy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate “what to look for” for a variety of audits, both technology-focused and more conventional areas in which technology has “encroached”.

 

~TJK