Since 2013, YODA, a Yale University-led initiative, has effectively disseminated clinical trial information from Johnson & Johnson and Medtronic to outside scientists.
Medicinal studies create a lot of information that never sees the illumination of day, but a Yale University-led project is attempting to alter that.
The Yale University Open Data Access (YODA) Project has been developing an interface that enables other experts to unlock data from pharmacological firms’ clinical trials since 2011.
Collaborators released their study of YODA’s accomplishments and difficulties so far in Scientific Data last week (November 27).
Mark Huffman, a cardiologist at Northwestern University who did not take part in the survey but has utilized the YODA platform to extract content from a Johnson & Johnson trial, says,
“It’s great to have a synopsis of YODA, which has been one of the figureheads of data exchange stations that have emanated over the past five-plus years.”
“Assist in identifying some prospects for how data sharing may progress utilizing this model.”
What is the purpose of the YODA initiative?
The YODA project began from the efforts of coauthors Joseph Ross and Harlan Krumholz, both Yale University physicians, who discovered how much detail was omitted from the scientific journals, especially randomized study papers.
According to Ross,
“Roughly half of [clinical] studies conducted in the United States are never published.”
“Even those that don’t provide all of the information that one would need to better understand the safety and advantages of a certain therapy.”
Why should you be concerned?
The creation of YODA, according to Ross, was prompted by a desire to have more of this info collected.
His team started by creating protocols for information exchange among partner companies, as detailed in the new study.
The Yale group has emphasized disclosure throughout the procedure, including being available to scrutiny comment on important matters such as authorization of ultimate initiatives for making a clinical trial project related, and requiring pharmaceutical companies to defer to intellectuals as autonomous judgment when confronted with user information.
Any researcher requesting medical evidence must file a study petition, and YODA authorities value patient privacy and ensure that the information is not shared.
YODA also mandates that receivers of drug company data publish their findings, ideally in the biomedical literature or at scientific conferences.
Currently, data access is unrestricted.
The importance of Open Access
- Beginning in 2011, YODA collaborated with Medtronic to allow the exchange of individual participant data from both published and unpublished studies for a product called recombinant human bone morphogenetic protein-2.
- The cooperation terminated in 2015.
- Four teams were given de-identified data to examine using their own tools as part of this collaboration, and two papers have been published thus far.
- In one research, individuals who received Medtronic’s medication instead of a bone transplant after spinal fusion surgery had better clinical results.
- These patients included smokers and persons under the age of 60.
- Sick people who have effective spinal fusions report less discomfort than those who have failed spinal fusions, according to another study.
- After the usage agreement expires—in this example, five years—the foreign scholars will be obligated to delete the data.
- In 2014, YODA formed a long-term partnership with Johnson & Johnson to gain access to clinical trial data from pharmaceutical, consumer, and medical device goods.
- As of August 2018, 90 of the 100 requests for findings from the 270 clinical studies that were accessible had been accepted, eight had been abandoned, and two were still pending.
- The majority of the projects spawned by those proposals are currently in the works, with 12 publications so far.
- For example, in one meta-analysis, data from trials of the antipsychotic risperidone were combined with results from trials of other antipsychotics to see if using these drugs increases the risk of mortality in patients with severe mental illness.
- There was no indication of a connection between acute antipsychotic drug usage and death, according to the scientists.
An answer to a major issue
- This data-sharing arrangement differs from the Medtronic collaboration in that other researchers must access the data through a virtual analytics platform and are not permitted to download the results.
- This posed a number of difficulties. The structure, according to the report’s authors, limited the analytical tools accessibility, made adding complementary data to be analyzed alongside corporate data difficult, and resulted in time lost while learning the platform or when users were logged out suddenly and hadn’t saved their work.
- Huffman ran across these issues while trying to use YODA to get data from a Johnson & Johnson cardiovascular study for a replication analysis his team published in JAMA Cardiology in 2017.
- “We discovered that we had subtle differences in our replication analysis, which were largely driven by the way in which some of the datasets were defined,” he says.
- “When we think about what investigators need to do… it’s not just the data that need to be shared, but there are things like the statistical code and data dictionaries” that take time to prepare and should be shared as well.
“When setting up their data capturing systems, investigators conducting clinical trials and other research should consider data sharing on the front end, not only on the back end.”
While he admits that the site was not the most user-friendly, he adds he would use it again if more cardiology trials were accessible.
There’s only one right now.
Data sharing’s stumbling blocks
- “Getting ready datasets for sharing is a hassle, and it’s nothing [businesses] get paid or incentivized for,” says Michelle Mello, a Stanford University health law researcher who was not engaged in the study.
- She believes that one of the reasons for the broad range of attitudes regarding data sharing across pharmaceutical corporations is the work and time needed.
- According to Mello, initiatives like YODA pose additional big-picture concerns, such as whether “gatekeepers like the Yale group are needed or should corporations do this directly?”
- Another question is if we have separate groups coordinating data sharing, what should they do when determining whether or not to share data?
- She says, “My sense is that things will grow more standardized over time.”
- The main challenge for Ross and his YODA colleagues right now is long-term funding for the project—and for research based on shared data.
- “Right now, the corporations are putting a lot of money into it, and we believe we’ve established a mechanism that will assist research and the scientific community work with secondary data more effectively,” he adds.
- “But now we have to think about how we engage with the wider world of funders to… make sure that there are really funds available to assist individuals working with data like this, rather than just grants to support people collecting data,” says the author.
Data Sharing in Action — When Drug Companies Open Their Trial Vaults!
The time has come for drug companies to open their trial vaults.
Sharing previously unreleased estimates can help patients, doctors, and researchers make better decisions about which drugs are worth pursuing.
The pharmaceutical business has long been one of the world’s most profitable and well-protected industries.
However, as research transparency grows, it becomes obvious that data sharing is crucial not just for assisting scientists in the discovery of novel therapies, but also for navigating healthcare costs and accelerating medication development.
We hope you liked today’s discussion about the benefits of open data!