Can Digital Technology Improve
Clinical Trial Success?
Most of the clinical trials from pharmaceutical companies will fail. But that doesn’t mean they have to. According to a recent report, many trails fail due to unforced errors, not drug efficacy. More than 50 percent of drugs rejected by the U.S. Food & Drug Administration (FDA) fail because those involved in the management of the studies do not promptly follow the FDA’s feedback, don’t file forms on time, or don’t correctly understand the timing of crucial parts of the FDA’s review.
Several startup companies are attempting to make processes easier for biotech and pharma firms to improve protocol design and study execution through the use of digital technology and artificial intelligence. Click here for more information.
Updated Diabetes App
Focuses on Patients & Care Management
Officials at Glooko, a software and data management company that specializes in diabetes care technology, have announced the newest version of their diabetes management mobile application and a human factors study on its Mobile Insulin Dosing System for long-acting insulin titration, which was cleared earlier in 2018. The new app focuses on features that add context to glucose and insulin data and reportedly simplifies the tracking of personal lifestyle events such as exercise, diet, and medication. The company syncs data from the world’s most popular diabetes devices and major fitness and activity trackers, and supplies personalized, timely insights, according to officials. More than 7,000 clinics and 1.5 million patients in 23 countries across 15 languages utilize the company’s devices, officials said. Visit www.glooko.com for more information. The insulin pens NovoPen® 6 and NovoPen Echo® Plus are expected to be commercially available across key markets in early 2019 through partnerships between the pharmaceutical company Novo Nordisk® and technology companies Dexcom,® Glooko, and Roche. The partnerships will reportedly aim to advance the solutions available for people living with diabetes and their healthcare professionals. Building upon its existing work with IBM Watson Health® and Glooko, Novo Nordisk aims to seamlessly integrate insulin dosing data from connected pen devices with its partners’ open ecosystems and diabetes management solutions, such as data from continuous glucose monitoring (CGM) systems and blood glucose meters (BGM), according to a press release distributed by Glooko.
“Our nonexclusive partnership strategy allows us to integrate with the various digital platforms that people are already using to help manage their diabetes,” said Camilla Sylvest, executive vice president of commercial strategy and corporate affairs at Novo Nordisk. “We firmly believe that this will help more people realize the full benefit of our innovative medicines and begin to ease the mental burden of diabetes treatment for those individuals.” The launch of the insulin pens is expected in the first quarter of 2019 and will roll out to more than 50 countries in the coming years, officials said. The instruments will also eventually be phased in to replace NovoPen® 5 and NovoPen Echo® in countries where those devices are currently available. “After receiving caregiver feedback, we knew a global rollout was the right thing to do,” said Sylvest, referring to a 2017-18 Swedish pilot in collaboration with Glooko. “During the pilot, healthcare providers noted that patient dialogues improved without having to invest additional time.” “Synching Novo Nordisk insulin data with our digital diabetes management solutions like mySugr and Accu-Chek Smart Pix will allow us to enhance quality of care and help create more sustainable healthcare systems,” said Marcel Gmuender, global head of Roche Diabetes Care.
Novo Nordisk will also reportedly integrate insulin dosing data with Dexcom CGM data in the coming years. “We believe that a fully connected ecosystem represents a significant opportunity to improve the lives of people on multiple daily injections,” said Steve Pacelli, executive vice president of strategy and corporate development at Dexcom.
“We are pleased to extend our collaboration with Novo Nordisk,” said Russ Johannesson, chief executive officer at Glooko. “We are excited about evolving our integrated solutions and look forward to helping more people manage their diabetes via the Glooko platform.”
Beyond launching connected durable devices, Novo Nordisk expects to deliver connectivity for its disposable, prefilled injection pens later in 2019. In the longer term, Novo Nordisk aims to increase the availability of connected pens and offer solutions for personalized treatment guidance.
HIMSS Submits Comments on IT Burden Strategy
The U.S. Department of Health & Human Services (HHS) has issued a draft strategy on improving burdens related to information technology (IT) and electronic health records (EHRs) that is currently available for public comment. The report “Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs” will be available for comment until Jan. 28. The community is asked to provide its ideas and recommendations on how best to address burden issues and position clinicians to provide effective care to patients while maintaining an appropriate work/life balance.
The 21st Century Cures Act called for HHS to conduct a thorough analysis of the drivers of burden and required that the government and industry work together to reduce the burden of using health IT and EHRs. The report outlines three primary goals for reducing healthcare provider burden:
- Reduce the effort and time required to record information in EHRs for healthcare providers during care delivery.
- Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and healthcare organizations.
- Improve the functionality and intuitiveness (ease of use) of EHRs.
Moreover, the report describes sources of EHR-related burden, as well as strategies and recommendations that HHS and other stakeholders can pursue to achieve burden-reduction goals. HHS is focusing its efforts on the following criteria to ensure it is putting forth both high-impact and feasible strategies, officials said:
- Strategies should be achievable within the near to medium term, a roughly 3-5-year window.
- HHS should be able to either implement these strategies through existing or easily expanded authority, or should have significant ability to influence the implementation of these strategies.
- Strategies should include actions that improve the clinical documentation experience and improve patient care.
- The four categories of strategies identified in the report include: clinical documentation, health IT usability, EHR reporting and public health reporting.
According to officials with HIMSS (Healthcare Information and Management Systems Society), the organization has been active on the topic and has worked with the Association of Medical Directors of Information Systems (AMDIS) on written comments to HHS on the “Patients Over Paperwork” initiative by the Centers for Medicare & Medicaid Services, specifically focused on ideas to help reduce the burdens placed on clinicians. HIMSS and AMDIS shared the belief that much of the work that clinicians face today is unnecessarily burdensome, where burden is defined as clinician activity that does not serve patient interests, does not improve quality or safety, or regardless of intent, is highly inefficient, said HIMSS officials. The organizations have reportedly asked to work with HHS to eliminate these actions that occur in the course of clinical practice. Ultimately, HIMSS and AMDIS want clinicians to be able to focus their time on actions such as caring for patients and delivering better outcomes, HIMSS officials said.
Additional key thoughts and recommendations from HIMSS and AMDIS are reportedly focused on creating an environment wherein the burden on clinicians is minimized while promoting streamlined regulations, increased efficiencies, and an improved beneficiary experience.