Category / tjkuhn
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines The following statement is attributed to FDA Commissioner Stephen M. Hahn, M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 infection in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness. We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19. The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose. What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively. Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies. Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning, as there is some indication that the depth of the immune response is associated with the duration of protection provided. If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks. We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health. We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 
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
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
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
5 Best Online Tools for Searching Flights
As a frequent business traveler, I’m partial to Google Flights (our internal system is pretty poor for finding/optimizing flight times/costs)….but Your mileage may vary…
~TJK
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
The long-awaited death of cash may finally be coming – CNET
Some interesting perspectives on cash going away as it is usurped by electronic payments, apps, etc. I think we’re still a long way from that though. One of the guys I works with prefers cash at lunch….”because there is no record I was even here.” Though I love electronic payments…..He’s kinda right.
~TJK
Source: The long-awaited death of cash may finally be coming – CNET
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.”
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
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.
Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies | FDAZILLA BLOG
New warning letters out! These are largely GMP-specific. Like no other agency, FDA is reknowned for updating regulations via warning letter (rather than the onerous process of getting an actual new or updated regulation approved)….so it is good to always keep an eye on these to be clear on “FDA’s current thinking”. YMMV. In any case, check out the full information at the link below!
~TJK
Source: Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies | FDAZILLA BLOG
T. J. Kuhn | GxP Zone 