Harvard Bioethicist Talks Clinical Data-Sharing During Dean’s Lecture Series

The pharmaceutical industry expends vast financial and human capital annually in the race to discover the next breakthrough drug to take to market. However, clinical trials require years of study and millions of dollars in funding to complete. Moreover, these trials are often done in silos and the closer companies get to approval, the less their data is shared.

This begs the question: Is there an ethical obligation for companies to share data from their clinical trials with one another?

"Most would say no," said Rebecca Li, Ph.D.

Li, a lecturer at Harvard Medical School and a member of the Harvard Medical School Center for Bioethics, tackled this topic on Oct. 16, 2024 during her Dean’s Lecture Series presentation, “Driving Scientific Innovation through Data Sharing” at Stevens in conjunction with the Semcer Center for Healthcare Innovation (CHI).

"The closer that scientists inch toward commercialization of drug products, the more difficult it becomes to share their work openly," added Li. "And that is because science is propelled forward by different kinds of incentives."

The obvious motivation is competition. However, Li sensed a shift about seven years ago in which researchers no longer felt they could keep their data under wraps. There has been a continuous movement toward setting data free, but more in a pure sharing method as opposed to traditional collaboration.

Whereas collaboration is more a classic quid-pro-quo arrangement, Li referenced the FAIR method of data sharing, meaning making data more findable, accessible, interoperable and reusable. However, FAIR sharing requires a platform or repository through which to share the data.

And that is what led Li to her current role as CEO and co-founder of Vivli. 

Sharing Research on the Secondary Market

Vivli is a global nonprofit organization based in Boston, featuring a platform that includes an independent data repository, an in-depth search engine and a secure research environment. Vivli users can search listed studies, request data sets from data contributors, aggregate data or share data of their own.

During the lecture, Li gave a real-world example of how this plays out with Crohn’s disease, a medical condition gaining increasing interest in the healthcare community. A researcher seeking data can acquire high-quality data much more efficiently than the traditional time-consuming and expensive clinical trial model.

A researcher can request already-completed trial data through Vivli. They can go into the system, request the data and ask questions such as: Are there subgroups responding better to some drugs than others? How much time was required to receive a favorable response to treatment? What data do we need to make this determination? Are other groups more prone to adverse responses?

Overall, a researcher looking into Crohn’s disease could acquire data from 5,000 patients across 10 clinical trials through Vivli.

"Each clinical trial was taking five years of my life, probably even more," said Li. "I’d have to get 20 million dollars to fund that trial. But I could use secondary sources and actually get publications from it."

Rebecca Li (left) and Stevens president Nariman Farvardin Jeff Vock

Today, Vivli is the largest platform of raw data from clinical trials, boasting more than 7,000 trial data, 1,000 citations, 300 publications and 55 members. Pfizer shares its COVID data through Vivli.

Speaking of COVID, Li believes that data sharing can help lessen the risks of future pandemics. In fact, antimicrobial resistance (AMR) is a popular area of secondary research on Vivli, as researchers see AMR as a potentially significant issue down the line.

With hundreds of thousands of deaths globally due to AMR, a central repository of industry data was needed for the international medical community to track resistance patterns and model potential future patterns. Through funding, 88 countries have submitted data accessible to pharmaceutical companies across the world. The first large data platform to centrally store this trove of AMR data, Vivli allows the global scientific community to draw from the same source. 

Be it COVID, AMR or other prevalent medical conditions, the increased sharing of trial data via Vivli could help fight a variety of diseases and spark breakthrough discoveries.

"Sharing of data represents really important opportunities to drive forward scientific insights and progress, as well as to develop research careers," said Li in her closing statement to a sizable audience of Stevens faculty and students. "It is my hope that these precious data resources are utilized by researchers to accelerate scientific goals and open up new avenues of intellectual pursuit ."