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Data sharing. It is an important topic and there is a real need for it in our community. Data sharing encourages more connection and collaboration among researchers, which can result in important new findings within the field.

In a time where resources for science and research are limited, data sharing is more efficient because it allows researchers to share resources. Unfortunately, it is not as easy to implement as it sounds. There are a lot of regulations and policies that need to be addressed first.

The good news is that data sharing is not going away and conversations in the community are continuing, so we are hopeful that one day soon, data sharing will be a normal part of our day’s work.

Here at ARC, behind the scenes, my colleagues and I are actively pursuing potential options to help facilitate data sharing in our amyloidosis community. There is a lot to do before we see the fruits of our labor, but knowledge is power!

Because we believe so strongly in the power of data sharing, I could not refuse when I was asked by Vivli Center to participate in their annual meeting in September. I was quite honored; sharing data within a rare disease is even more complicated than in other therapeutic areas because of the limited number of people affected within a rare disease. And this meeting was my soap box to raise awareness of Amyloidosis and the challenges we face in our community with regards to data sharing. The theme of the meeting was Working Together to Transform Data Sharing. Working together is the way forward; and this meeting lived up to the expectations! I was invited to sit on a panel to discuss the challenges of sharing small datasets and rare disease data. We talked about the risks of data sharing and the potential for re-identification, especially in rare disease. In general, I think patients are more than willing to share their data, but industry sponsors are heavily regulated to protect patient privacy. So how do we balance the risk and benefits and still make the most of the data? Well, we need to think creatively. There is no one solution to fix this problem. This could mean including a box on an informed consent that allows for the data to be shared in a secondary capacity. Or maybe there could be an opportunity to use Application Programming Interface (API) technology to create applications that could access data from various sources to one center storage vault, allowing patients to share data. I think we will continue to see new developments, like the National Institutes of Health (NIH) All of Us is research program. This research program allows participants to share data in a protected way, approved researchers can use this data to conduct studies, and participants will get information back about the data they provide, and researchers get to share their discoveries. Maybe someday soon we will see consent forms electronically collected within a participant’s electronic health record. We are hopeful that we will continue to see opportunities for education and awareness for data sharing and continue to break down the barriers. I think Vivli’s CEO, Rebecca Li said it best: “if we don’t share data, it is used one time to answer one question.”

I sat in a room full of representatives from industry and government agencies, patient advocacy groups, scientists, biostatisticians, and researchers, who all were there with a common goal: addressing this unmet need to share data. We talked about crucial topics starting with the informed consent forms (ICFs) and the challenges often seen now with older data. ICFs were created to inform participants about specific information regarding the study, and, based on the information participants could make thoughtful decisions regarding participation. Patient consent varies depending on the context, but the biggest challenge with data sharing is the specificity of the consent language. When a patient signs an ICF they agree to the use of the data as described within the document and that is it.

Promises made to research subjects at the time of consent must be respected. If the clinical trial is decades old, the data collected from it cannot be used or analyzed in any other way in some new study (unless otherwise specified), even if the data is still relevant So, what does this mean in terms of data sharing? Well, since we cannot change the past, we can learn from this, and begin to include broader language and consents to allow for secondary use of the data. This, however, will take some time as academic centers, IRBs and Ethics Committee develop new policies and find the right language to ensure both patient privacy and enable the shareability of the data.

Another hot button topic, although not specific to the United States, is the European Union’s rules around General Data Protection Regulation (GDPR) which is the most important change in data privacy regulation in 20 years. GDPR contains pathways to permit sharing of data for transparency, but little guidance about how to do it, leaving much of the interpretation to the end users. While these regulations are a step in the right direction, there are many areas where additional clarifying guidance from regulatory bodies is still needed before these rules become easily incorporated into standard practice.

So, how can we promote data sharing and open opportunities to build on research and make progress fighting a variety of diseases? Again, there is no one solution to fix this problem, but I did hear some insightful recommendations. I heard from a representative from ImmPort, and how their data repository is helping to improve the sharing of data. If you’ve never heard of ImmPort, it is a public data sharing repository for immunology research and clinical trials that is funded by the Division of Allergy, Immunology, and Transplantation (DAIT). Though mainly archiving datasets generated by DAIT-funded projects, ImmPort hosts data from a growing list of programs from other NIH institutes and non-profit foundations.

We also heard some great thoughts about ways to incentivize academic institutions to share their research from the Association of American Medical Colleges, which launched the Credit for Data Sharing initiative to describe and implement a system to appropriately credit researchers for sharing data.

We heard from a representative of the New England Journal of Medicine who highlighted the need for greater clarification from authors about their data sharing plans. She spoke about the many reactions that she has experienced as a result of the Journal’s new guidance from Jan. 1, 2019 that requires researchers wishing to publish in the Journal to declare their data-sharing plans in a public registry, such as

All in all, it was exhilarating to hear from leaders throughout the research community who shared their insights on data sharing. There is still much more that we can do, however, to promote data sharing. I learned so much in just the short time I was there. I left with a newfound wealth of knowledge and a lot more homework, but I am excited to see the next steps.

Robyn Himick
Associate Director, Clinical Research
Amyloidosis Research Consortium