News & Events

Global research nonprofit CureDuchenne joins Vivli to share clinical trial data for treating muscular dystrophy.

CureDuchenne, the leading global nonprofit focused on finding a cure for Duchenne muscular dystrophy, will contribute patient-level clinical data to the Vivli platform, making it available to other researchers around the world. The data will augment existing studies that are available to request on the Vivli platform, which currently hosts data from over 4,700 trials.

Duchenne is the most common and lethal form of muscular dystrophy. Nearly 15,000 boys are living with the disease in the United States alone and over 300,000 worldwide.

“We’re committed to sharing data as a way to fuel treatment breakthroughs for muscular dystrophy. Vivli makes that possible.” said Debra Miller, founder and CEO, CureDuchenne.

CureDuchenne will make available individual participant data collected, after deidentification, from phase 2 and phase 3 clinical trials of the drug drisapersen, as well as observational studies.

“We’re delighted to have CureDuchenne join as a member of Vivli and make this valuable data available. We welcome researchers interested in Duchenne to visit the Vivli platform to access these datasets and potentially uncover new insights in muscular dystrophy,” said Rebecca Li, Vivli Executive Director. “The Vivli platform is a secure and user-friendly place to store and share data from clinical trials regardless of sponsor, and we look forward to welcoming more nonprofit research entities to Vivli.”

About Vivli

Vivli is a non-profit organization working to advance human health through the insights and discoveries gained by sharing and analyzing data. It is home to an independent global data-sharing and analytics platform which serves all elements of the international research community. The platform includes a data repository, in-depth search engine and cloud-based analytics, and harmonizes governance, policy and processes to make sharing data easier. Vivli acts as a neutral broker between data contributor and data user and the wider data sharing community. For more information, visit www.vivli.org and follow us on Twitter @VivliCenter. Watch the video on why data re-use matters: https://www.youtube.com/watch?v=NVqK8VCnk9Y

About CureDuchenne

CureDuchenne is the nation’s leading nonprofit organization dedicated to finding a cure for Duchenne, the most common and lethal form of muscular dystrophy. As the leading genetic killer of young boys, Duchenne affects more than 300,000 boys living today. CureDuchenne has garnered international attention for its efforts to raise funds and awareness for Duchenne through venture philanthropy. For more information on how to help raise awareness and funds needed for research, please visit www.cureduchenne.org.

UCB makes its patient-level study data available for requesting using the Vivli Platform. 

“We are delighted to welcome UCB as a member of Vivli and to work with them and
other members to securely share their studies with researchers,” said Rebecca Li, Vivli Executive Director.

UCB is a global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology.

“UCB has worked with the Vivli platform and its team as it has grown and developed and we are thrilled to be joining Vivli,” said Liz Roberts, Senior Director, Strategic Data Opportunities Policy Lead at UCB. “We look forward to working with the Vivli team as well as the other members to continue to share our data and advance scientific research.”

For more information about how UCB shares data on Vivli, please visit their member page. For additional information about Membership in Vivli, learn more here.

The NIH asked for public input on a NIH data management and sharing policy proposal.

Full details on the DRAFT NIH Policy for Data Management and Sharing and the Supplemental DRAFT guidance can be found here.

Below are the comments that Vivli submitted.

As the world’s largest funder of research, NIH has a major leadership opportunity to significantly impact data sharing by updating and aligning its data sharing policy with contemporary best practices. Sadly, this recently issued draft policy does not reflect the major step forward we had hoped for, but is simply an incremental change over the last policy.

Vivli is a non-profit organization founded in 2018 that manages the world’s largest clinical trial data sharing platform. We provide a single point of search and request to participant-level data from over 4700 trials representing 2.2 million participants from 109 countries. Our comments are restricted to clinical trial data sharing, which we believe has the broadest and most immediate impact on advancing human health by accelerating new findings through data reuse. Moreover, clinical trial data sharing also respects trial participants’ assumption of personal risk to contribute to science by maximizing the value of their contributions.

The plan as currently drafted is significantly weakened by choosing “deliberate flexibility” over a robust and clear mandate for clinical trial data sharing. Typically, flexibility in the conduct of science is a benefit; however, in this instance this approach significantly weakens our accountability to participants. We recommend at a minimum that the following be mandated elements within the data sharing plan with respect to clinical trials data rather than “flexible” elements managed at the discretion of the investigator:

• The current proposal leaves open the timeframe for when data would be made available to users at the discretion of researchers. We recommend that NIH funded clinical trials require reporting of individual participant-level data (IPD) to an approved repository within a reasonable time period. The National Academy of Medicine Report has suggested a practical timeframe of 18 months post-trial completion.
• The current proposal does not bind clinical trial proposals to declare a particular trial repository in the data sharing plan. We strongly recommend that NIH establish clear standards, criteria and best practices for clinical trial data sharing repositories, maintain a list of these approved repositories, promote awareness among researchers of this list, and require investigators to declare which approved repository they will be using.
• For clinical trial proposals, NIH should institute a requirement that demonstrates a rigorous search of prior relevant summary and IPD results in the research plan section. This would ensure that duplicative trials are not initiated, and we are respecting our participants contributions by leveraging them to the fullest.

In conclusion, Vivli strongly supports mandatory data sharing for clinical trial proposals. Investigators who that do not meet minimum thresholds should have direct measurable rewards and consequences based on their data sharing performance. Perhaps the single most impactful change to the current draft policy would be to score the data sharing plan during the grant review process and ensure that this score impacts the funding decision. We have waited for 15 years for this important update to the NIH’s data sharing policy. As this new policy lacks any effective mandate for sharing of clinical trial data, it in effect relinquishes NIH’s responsibility to the research community, researchers and patients. This incremental proposal if enacted would signal to researchers that clinical trial data sharing is a voluntary endeavor, which breaks trust with trial participants’ strong desire to share. We can do better.

NIH is in the enviable position of being able to alter incentives and investigator behavior in ways to produce lasting changes for future generations of patients if this proposal is crafted carefully. We appreciate the opportunity to share our perspective, and we urge the NIH to consider our suggestions carefully in the next draft of its data sharing policy and to lead in clinical trial data sharing.