The Laura and John Arnold Foundation has recently donated $2 million in funds to Vivli, a Massachusetts nonprofit, for establishing a unique data sharing platform for use in clinical trials.
“This financial support allows us to quickly move to launch the platform in 2018,” said Dr. Ida Sim, Vivli co-founder and technical lead. “Vivli’s technology and coordinated policies and processes will lead to new scientific discoveries from integrating existing datasets.”
Included in the Vivli platform will be a centralized data repository that hosts clinical trial outcomes, a variety of data analytic tools and a search engine to enable quick retrieval and analysis of existing data sets. According to a statement from Vivli, the goal of the new platform is to “provide transparency and access to clinical research data from around the globe, break data out of existing silos and accelerate scientific discovery to improve human health.”
Support from the Laura and John Arnold Foundation will help Vivli finally address the significant challenges regarding data sharing in clinical research. “The clinical research and pharmaceutical markets demand a one-stop-shop to aggregate clinical research data, provide an easy-to-use search interface and offer tools for select data analysis,” according to a statement from Vivli.
Overall, the aim of Vivli’s data sharing platform is to assist both public and private institutions in optimizing “time, effort and financial resources spent on research, as well as unearth new insights that will lead to critical discoveries by making it easier to combine different data sets in new ways at the individual patient data level.”
The current analysis tools planned for the data sharing system include R, Python, SAS, and STATA.
“The primary goal of Vivli will be to advance insights and discoveries to improve human health,” added Rebecca Li, Ph.D., executive director of Vivli. “The potential for Vivli to make it easier for researchers to interrogate data more easily and quickly is tremendous. This will ensure that we are optimizing the contributions of patients who participated in clinical trials.”
In addition, Dr. Li believes a data sharing platform will ensure improved efficiency of dollars spent for research.
Sharing clinical trial data provides a vast knowledge base regarding specific diseases or therapies, of which researchers can build upon for the discovery of new approaches in medical practice and patient care. Additionally, access to complete data sets may allow clinical trial investigators to ask and answer new questions while performing large-scale analyses more efficiently.
The concept of sharing clinical trial data is nothing new. Since the 2007 adoption of the Food and Drug Administration Amendment Act (FDAAA), U.S. regulation requires the submission of results generated by clinical trials to the ClinicalTrials.gov online database.
In 2016, the International Committee of Medical Journal Editors (ICMJE) proposed data sharing guidelines for researchers involved in clinical trials. According to the organization’s proposal, trial investigators should actively share de-identified patient data as a means for “improving the transparency of clinical trials for consumers and the academic medical community.”
One of the prime goals of data sharing is to improve transparency regarding conflict of interests, which are inherent in trials when external funding is necessary for a trial to proceed. Sharing clinical trial data may possibly protect against the potential influence of these external funders and improve the communication of potential conflicts. “Disclosing clinical trial information and creating transparency around the data are big steps toward increasing trust between the public and the industry,” explained Thomas Wicks, CSO of TrialScope, a company geared toward improving clinical trial transparency.
Patient privacy is another crucial consideration when it comes to data sharing, a consideration that some investigators feel could complicate the data sharing process. The answer may lie in the sharing of only de-identified patient-level data, thereby providing future researchers access to a trial’s underlying results without compromising patient confidentiality. These de-identified patient data may ultimately facilitate validation of results obtained in future trials as well as enable re-evaluation of data sets in reviews and meta-analyses without privacy concerns.
A statement published by Elizabeth Warren, J.D., in the New England Journal of Medicine, urged members within the clinical trials community to consider additional strategies for improving clinical trial data sharing, particularly those that have resulted in null, inconclusive or negative findings. “Encouraging the publication of such trials and the release of their underlying data will help to further accelerate medical progress, uphold the ethical standards of human-subjects research and help in holding industry sponsors accountable,” said Warren.
At present, Vivli is actively bringing new staff members on board to create more speed in the implementation of their platform. “We are still accessing additional tools that may be available by launch, but hope to be making further announcements early next year,” concluded Dr. Li.
This article was reprinted from Volume 21, Issue 40, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »