What's Your Top Ten?

How would your list of the top 10 medical advances in history compare with this list from Proclinical? When we discussed this at Polaris, we were struck by those advances that have greatly improved and extended the lives of our elderly family members – like artificial joints and pacemakers, for example -- that no previous generation could have imagined, let alone benefited from.  #gratitude

WHO Cares About Data Integrity
World Health Organization

Yes, WHO cares. In October, the World Health Organization published a set of draft guidelines on Data Integrity. Given the complexity of the topic, the draft is surprisingly (and refreshingly) easy to read.

We especially like the discussion of ALCOA and ALCOA+ (the ALCOA extension that says data should be complete, consistent, enduring, and available). The guidelines provide detailed examples of each attribute.

We were also pleased to see an emphasis on Good Documentation Practices (GDP). Lack of GDP is not an uncommon audit finding, and our clients often ask us to write or review SOPs on GDP for them.

Just the FAQs, Ma'am

A new FDA webpage provides all of the GCP-related e-mail questions submitted to the FDA between 2013 and 2018, and FDA’s responses to them. The 1000+ inquiries sent to are currently organized into 15 categories:  AEs, Computers, Devices, 1571/1572, Financial Disclosure, Foreign Studies, GCP, Health Insurance Portability and Accountability, Human Subject Protection, Informed Consent, Inspections, IRBs, Recordkeeping and Retention, Special Populations, and Training and Qualifications. This organization will most likely evolve as the database of Q&As grows.

Bookmark This Table

Looking for a handy cheat sheet to remember the differences among Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval? Yeah, you were. You can stop looking because here it is.

A Little Birdie Told Us
Janet Woodcock, FDA’s CDER Director, spoke to Congress about domestic drug manufacturing and oversight. FDA live tweeted the October event, and Polaris was right there, following the discussion, so you didn’t have to. Here are some of the highlights, as captured in 7 tweets.

(1) Woodcock confirms declining number of surveillance inspections for manufacturing facilities, says the cause is staffing issues (but not a funding issue).
(2) For-cause inspections are unannounced, but most of the surveillance inspections are announced, she adds. On whether that’s prudent: It’s a trade-off, if FDA sends a lot of people to a site that isn’t producing or open, it's a waste of time.
(3) Critical factors such as the availability of raw materials can have a major impact on drug supply and the U.S. is not a major supplier of these materials.
(4) The U.S. pharmaceutical sector has moved out of the country starting in the late 1990s and this trend has been accelerating based on economic factors.
(5) FDA has been advocating for the modernization of drug manufacturing since early 2000s. Advance manufacturing such as continuous production, use of automation, and digitalization may help promote domestic manufacturing.
(6) These techniques result in smaller facilities, less environmental impact and the need for smaller but highly skilled workforce. All factors that make production in the US more feasible.
(7) FDA is working hard to assure a robust and reliable drug supply for the US. It’s important to re-establish the pharmaceutical manufacturing sector in the US, but also help bring about a high quality resilient drug supply for all the worlds citizens.

eConsent with Benefits
DIA Global Forum
An electronic Informed Consent system offers more than alternate media for the clinical trial consenting process. The metadata it collects can provide insights about recruitment, retention, and compliance, as well as improving documentation and education materials. What could be learned from tracking the amount of time it took patients to complete the consenting process? What could be understood about the quality of the materials by analyzing quiz data?

Ad In / Ad Out
Kimberly Compton
IRBs pay close attention to study recruitment advertisements, making sure that risk and potential benefit information is balanced and fair. Ads should not mislead, for example, by promising or even implying benefits beyond that which a clinical trial could reasonably provide.  Here’s a concise enumeration of what is allowed and disallowed in clinical study recruitment advertising.

Home, Auto, Life,...Cyber?
Brian Mahon
When data is very critical, breaches are very costly. Does your company have cyber insurance? Do you need it? Here are 7 reasons why you might wanna look into it.

Polaris Compliance Consultants Corner

Have you heard of the Snowball Express? It’s an annual Walt Disney World event, sponsored by the Gary Sinise Foundation, for the children, spouses, and parents of our fallen military heroes. Last month, more than 1,750 Gold Star families attended, and Polaris’ Lauren Kelley was helping out in the teen room, interacting, organizing, and making sure everyone was well-snacked. The holiday season can be especially tough for these families, and the Snowball Express gives them an opportunity to bond and make new memories with those who truly understand their loss.

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