Deloitte’s 2018 year-in-review and look-ahead to 2019, is all about data and the accelerating pace of change in the pharma industry. “As the sector continues to face pressure to drive prices down and demonstrate the value of their products…At the same time, biopharma companies will likely continue to seek ways to reverse the declining return on R&D.” Great, but how? The author suggests 4 ways pharma should move forward (see if you can pick up the theme): 1. Embrace a digital-first mindset, 2. Use new forms of data to demonstrate value, 3. Collaborate with new partners, and 4. Find new ways to connect with consumers. Deloitte also expects more at-home diagnostics to enter the market in 2019. More data. According to Tufts, “The typical Phase III protocol now collects more than one million data points, double the level observed 10 years ago.” To see the power of simple data, go here.
Amazon is working tirelessly to find more and more pots to stick its Amazon Prime fingers in. The e-commerce goliath’s newest focus is healthcare, and it has two projects aimed at pushing in that direction. One is a secretive venture with the goal of (tell me if you’ve heard this one before) revolutionizing electronic medical records. The other is an investment that Amazon’s using to position itself as the solution for storing insane amounts of human genetic data. The company invested in Grail, a start-up planning to use its technology to flag the earliest signs of cancer. That requires a ton of data storage and processing, and if Amazon and Grail can pull it off here, you can bet it’ll be a huge market for them.
While perhaps overshadowed by an exponentially larger data breach, the healthcare sector had to deal with its own data attack this week. Quest Diagnostics—a pharma service provider and owner of the MyQuest™ by Care360 personal health app—announced Monday that a third party had accessed user data of 34,000 patients using their app. The intrusion left users’ names, dates of birth, lab results and phone numbers exposed. You may have recently noticed Quest Diagnostics in the news for their IBM partnership using Watson to advance precision medicine in cancer treatment. We’re not saying that has anything to do with the breach, but that’s exactly the kind of info an amoral robot with a singular mission would need for its cause. Just sayin’.
Health data security:
Source: Ponemon Institute
In a move lauded by clinical trial transparency activists, the EMA has begun to release the full clinical study reports (CSRs) submitted for drug approval on their website. These aren’t the paired-down, not-quite-as-public-relations-focused-as-a-press-release-but-still-not-the-whole-picture versions submitted in scientific journals, and they include all the info a sponsor might not want to publish themselves—like the details of a drug’s adverse effects. The reports will be redacted for patient data and commercially confidential information, and the EMA will be retroactively posting CSRs for products (approved, or otherwise) submitted to the agency for review since Jan. 1, 2015. In the meantime, maybe try some light reading with the 260,000 pages released so far.
Leaving an unencrypted laptop containing more than 2,230 patient records in an unlocked vehicle overnight might be a bad idea. Even more so when it turns up stolen and your company is facing its third major security breach in a single year. According to the U.S. Department of Health and Human Services (HHS), “Demographic information, clinical information, health insurance information, patient names, addresses, credit card numbers and their expiration dates, and dates of birth” are some of the data stolen during three incidents for Advocate Health Care Network in 2013. Those mishaps have resulted in a $5.5 million settlement with the HHS, the largest data breach settlement ever. Advocate, however, reports that there have been no indications that the information has been misused… Yet. Yay?
Dirty data is the worst. Protocol manipulation and selectively published outcomes pose a real threat to clinical trial validity and patient safety. But imagine a world where this is entirely preventable. With Bitcoin, the premise could become a reality. Bitcoin- an open-source, digital currency- can now be used in the clinical trial space to prevent questionable alterations to original trial protocol and pre-specified trial measures. Using an inexpensive publically distributed, time-stamped Bitcoin technology known as a “Blockchain”, alterations to study endpoints and data can verified by any interested third party. Furthermore, changing the original source is extremely difficult. So any individual thinking about adding their own creative spin on trial outcome is looking at an almost impossible uphill battle.