Blockchain Offers Patients and Pharmaceutical Companies New Ways to Engage
Blockchain is a game-changer for many industries, and one possibility that has excited a great deal of interest in the pharmaceutical industry is how it could reduce inefficiencies in time and cost throughout the clinical-trial process.
Maria Palombini, Director of Communities & Initiatives Development at IEEE-SA, says that one of the biggest problems confronting drug-makers in clinical trials and research is patient recruit-ment. “It is very difficult to get an adequate number of qualified patient subjects through the door. If drug-makers fail the enrollment deadlines, then it leads to increased cost, timeline delays, and can shut down a trial,” says Palombini. “There are many challenges with the current process, ranging from inability to identify and connect with more diverse patient pools, engagement and retention, and the lack of quality in the patient data. When you are dealing with required large samples of patients for Phase III and IV trials, then these problems only become amplified.”
What many industry consortia and working groups are currently evaluating and testing is the concept of a “patient-driven” health blockchain. Essentially, it would empower patients to take control of their health data – from DNA profiles to diagnostics to prescription history – to manage this on a public blockchain where patients have the authority to choose who they want to trans-act with, what data they want to share, etc. “If the patient manages his or her own record on the blockchain and consents to be queried while retaining anonymity, then clinical trials sponsors would have unprecedented access to subject pools. The benefits of this model are not limited to clinical trials sponsors; patients would also receive the data collected about them during the trial. This model would truly revolutionize the clinical trials recruitment process,” Palombini says.
But Palombini notes that this concept needs to be refined to become reality. “There are many factors – regulatory, protocols, processes, stakeholder positioning, patient education and more – that need to be redefined to make this work,” Palombini says. “We have the first key ‘block’ in place, the blockchain technology, and now the rest of the blocks all need to be strategically aligned to realize this promise.”
In February 2018, the IEEE-SA convened a diverse group of 102 professionals representing the critical parties throughout the clinical trials process at the Blockchain for Clinical Trials Forum in Orlando. The mission of this event was to provide a balanced perspective on the viability of the application and the next best steps to achieve outcomes, including where standards, industry and policy can expedite adoption. For more information on the blockchain for clinical trials work, visit http://blockchain.ieee.org/clinicaltrials.
To stay on top of the rapidly evolving world of blockchain, visit the IEEE Blockchain page.
The IEEE GET Program Sponsors Standards Availability Worldwide
In many parts of the world, there’s a need for basic forms of development, from infrastructure to wireless technology. The cost of a published standard for such projects is usually a small part of its cost—but it can still be a barrier for small communities, or for startup projects looking for fund-ing. “People from developing countries may not be able to pay the full price for a standard,” says Anasthasie Sainvilus, Contracts and Licensing Manager at IEEE-SA. “But the technology could be useful for improving their lives.”
IEEE-SA’s GET Program, through its sponsors, makes selected standards available at no charge to the public. An interested group that wants to see the technology being put to use will sponsor a particular standard, supporting IEEE to make it available worldwide in PDF form via the GETTM Program. For example, IEEE 802® documents enter the program six months after publication. The sponsors for standards range from the working groups that created the stand-ard; to industry consortia such as Accellera, Inc. and Green Electronics Council; to government agencies.
Areas of technology that are represented in the GET Program include design automation, nucle-ar power, safety and security standards, and environmental standards—even a voting machine standard, which has seen interest from small communities across the United States. “The pro-gram has been very successful, based on how many downloads there have been, from coun-tries across the Americas, Europe, and Asia,” says Sainvilus. “It really shows that IEEE’s tagline about advancing technology for humanity is not just a tagline.”
To become a sponsor of the IEEE GET™ Program, please contact the Contracts and Licensing Manager at firstname.lastname@example.org. Please visit https://ieeexplore.ieee.org/browse/standards/get-program/page/ to access the IEEE GET™ Program.
Standards Exchange Program Opens the Standards Process to Staff Worldwide
Your national standards body has signed an agreement to use IEEE standards. But if you’re a staff member of that standards body, what comes next? The Standards Exchange Program, one track of the Fellowship Program (see the feature article in this issue) provides staff members from national standards bodies the opportunity to observe and learn about the IEEE standards development process and technical areas. It’s also a chance to make connections with IEEE volunteers and staff and their peers in other countries.
“This is for people who are not the developers of the technical content, but the staff who help make these kinds of documents exist,” said Mary Lynne Nielsen, Global Operations and Out-reach Program Director at IEEE-SA. “We’re teaching the staff of national standards bodies about the variety of standards that IEEE has to offer, and what they have the potential to use in their nation through their agreements with us, especially via adoption agreements that allow those or-ganizations to directly adopt IEEE standards as national standards.”
IEEE-SA held its first Standards Exchange program with national standards bodies in December 2017, during the IEEE-SA Standards Board (SASB) meeting series. That year’s participants in-cluded employees of the national standards bodies of Ecuador, Rwanda, and Zambia, all of which have signed memoranda of understanding (MOUs) with IEEE. “The fellowship program was a very enlightening experience,” said Chileshe Kapaya of the Zambia Bureau of Standards. “It provided an opportunity to make contacts and connections that would have not been possible otherwise.”
As with other Fellowship Program tracks, the Standards Exchange Program includes both partic-ipation in standards meetings and overviews on specific topics of interest. “We give them some training when they arrive—what is IEEE, what is the IEEE-SA, how does our standards develop-ment process work, so they’re prepared for meetings,” said Nielsen. “Then we give them over-views on topics of interest that they’ve indicated, such as 5G, blockchain, power and energy, or IEEE 802. They engage directly with the staff at IEEE, seeing how we do things internally. They observe our standards process and they get a very broad view of what we do—so they can get the most out of their MoU with IEEE.”
IEEE Student Grants Support Researchers Using Standards in Their Work
There are two things students working on research projects can always use—funding and their name on a published paper. IEEE Standards Education has a way to provide them with both: IEEE grants for student papers on engineering and on technology topics making use of stand-ards as part of their research. The IEEE offers grants to both students and faculty mentors in support of graduate, senior design, or development and research projects in which industry technical standards (students do not need to use an IEEE standard) are applied to complete the project.
The program, called IEEE Student Grants, offers US $500 to student researchers of selected papers and an additional US $300 honorarium is given to their faculty mentor. The final paper is published by IEEE as a student application paper. “Students are doing considerable amounts of research, and any kind of funding at that level is beneficial,” says Rob Craig, Manager of Stand-ards Education Programs at IEEE.
“Putting standards into practice is something they’re going to be doing their whole careers,” says Craig, “yet most students don’t get any real understanding of standards on the undergraduate and graduate level. This program gets students involved in the standards process, so they un-derstand the importance of standards, and how critical understanding of standards is to their ca-reers long-term.”
Papers accepted for the grant and publication cover a wide range of standards subjects. IEEE 802®has been the most popular topic, as word of the grants has traveled within that research community, but subjects have included everything from semiconductor power and surge issues to medical diagnosis and technology, satellite imaging and more. The universities where re-searchers have received the grants cover the world—from the United States and Canada to Ita-ly, Sweden, Ukraine, Egypt, India and China.
To find out more about IEEE Student Grants, go here.