A: Like a healthy democracy, a healthy data system relies on a sophisticated set of checks and balances. The FDA’s system is highly protective against data hanky-panky.*
Today an FDA advisory panel meets to discuss Moderna’s vaccine data – with an eye towards recommending emergency use authorization. Your Nerdy Girls look forward to watching all nine hours with bated breath! (We are, after all, huge data nerds). In honor of the deliberations, we’re offering up a note of reassurance about the related data diligence.
Data protection comes into play early and often throughout FDA-regulated vaccine trials:
➡️ BEGINNING: Submit and commit.
Trial sponsors such as Pfizer and Moderna are required to submit detailed research plans well before the first volunteer is recruited (see references section for links). Sticking to a pre-committed plan prevents shenanigans such as mysteriously disappearing data points, shifting outcome measurements, and/or shortened study periods. Data geeks the world over have been hard at work combing through these protocols – academic scientists, journalists, and even Wall Street investment analysts! – so many eyes are on guard for tomfoolery.
➡️ MIDDLE: No peeking!
Trial data are held closely by an independent data safety monitoring board during the trial, preventing company (or government) interference with data accrual and monitoring. This independent board – not the company – vets data regarding halting trials for potential safety concerns, determining when sufficient sample sizes have accrued to appropriately end the trial, and reporting out efficacy estimates.
➡️ END: Recipe required.
The FDA requires trial sponsors to submit raw data files for review, along with written reports. Handing over the raw data is akin to handing over a recipe and full ingredient list – providing singular proof of what’s truly in the pudding. This transparency-promoting practice isn’t without controversy, notably, as it adds regulatory review time. But it IS effective at snuffing out the potential for statistical subterfuge.
On a more personal note: Data integrity isn’t a super sexy topic, but it is crazy important! Gratitude for all of the health data contractors and analysts out there keeping it all legit – never has your work been more noble.
Your Nerdy Girls
*”Hanky-panky” is the scientific term used by the one-and-only Dr. Fauci, as quoted in the Fierce Pharma piece below.
Good info about the coronavirus vaccine independent data safety monitoring board:
clinicaltrials.gov protocol entries for Pfizer and Moderna vaccines:
Speed vs scientific rigor in FDA regulatory review– discusses raw data submission and review
Nice commentary on the importance of transparency in vaccine clinical trials