Advancing Biomedical Research by Increasing Clinical Data Transparency and Sharing

While at dinner with some friends who are doctors and other healthcare workers, a discussion of comments made by President Obama in his 2016 State of the Union with respect to cancer research came up. My friends and colleagues were excited by the possibility of diminishing data “siloing”.
This is what the President had to say:
“Now, that spirit of discovery is in our DNA. America is Thomas Edison and the Wright Brothers and George Washington Carver. America is Grace Hopper and Katherine Johnson and Sally Ride. America is every immigrant and entrepreneur from Boston to Austin to Silicon Valley, racing to shape a better world. (Applause.) That’s who we are.
And over the past seven years, we’ve nurtured that spirit. We’ve protected an open Internet, and taken bold new steps to get more students and low-income Americans online. (Applause.) We’ve launched next-generation manufacturing hubs, and online tools that give an entrepreneur everything he or she needs to start a business in a single day. But we can do so much more.
Last year, Vice President Biden said that with a new moonshot, America can cure cancer. Last month, he worked with this Congress to give scientists at the National Institutes of Health the strongest resources that they’ve had in over a decade. (Applause.) So tonight, I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us on so many issues over the past 40 years, I’m putting Joe in charge of Mission Control. (Applause.) For the loved ones we’ve all lost, for the families that we can still save, let’s make America the country that cures cancer once and for all. (Applause.)”
Some history of the cancer moonshot project alluded to in the State of the Union (SOTU) speech can be found in published information:
“The Project Moonshot 2020 name reportedly came from a speech Vice President Biden made in the Rose Garden in October 2015, promising a “moonshot” to cure cancer. The speech itself was triggered by the death of Biden’s son to cancer.”
The relation of data siloing to the SOTU’s reference to a cancer moonshot was apparently a meeting of U.S. Vice President Biden’s staff with top cancer researchers on Friday, January 8, 2016. The Vice President has had a personal and public interest in the advancement of cancer treatments based on his experiences which culminated with the death of one of his adult sons from cancer the prior year.
As related by the New York Times, Mr. Biden asked his staff to invite cancer researchers to his office to get suggestions. In particular:
“A top White House aide said that the vice president had been particularly intrigued by the idea that a crucial stumbling block to advances in cancer research may be poor collaboration among researchers who so jealously guard their data that advances the same studies and work is repeated in multiple locations, wasting resources.” (Emphasis added.)
That got my attention. While my days working on cancer-related projects as a graduate student at the Memorial Sloan-Kettering Cancer Center, and then as an American Cancer Society Fellow at Columbia University are long behind me, I have been blogging on data sharing and transparency because it is of significant interest to areas of research interest to us. We are particularly interested in how to improve the availability and transparency of clinical trial data.
The cancer researchers, who were from the American Association for Cancer Research, apparently told Biden’s staff that a particular data sharing interest of theirs was related to genomic sequences of patient cancers:
“Some major medical centers, like Dana Farber, Memorial Sloan Kettering and Vanderbilt, use their own funds and funds from philanthropists to pay for genome sequencing. But then another issue arises, the group told Mr. Biden’s staff. Each medical center keeps its own records of what mutations were found, what drugs were tried and how the patients fared.” (Ibid. Emphasis added.)
The cancer researchers had already started a project to try to improve the situation:
“The cancer research association has started a pilot project with seven medical centers to share such information. It includes 17,000 patient samples … But different centers use different formats to store genetic sequencing data and have very different ways of describing patient outcomes.” (Ibid.)
In a prior post we had concluded:
“Therefore, the availability of clinical trial results is at present quite haphazard, despite the promise of databases such as ClinicalTrials.gov. Recommendations we have made to NIH for improvements to ClinicalTrials.gov will be presented”.
Here, I will excerpt recommendations made last year by Amerandus Research to the NIH in response to their request for comments concerning Clinical Trials Registration and Results Submission.
In summary, we proposed that:
“Three additions to the Notice of Proposed Rulemaking HHS NPRM RIN 0925-AA52, Docket Number NIH-2011-0003 regarding presentation of clinical trials data on ClinicalTrials.gov are proposed:
1) the trial’s responsible party will state explicitly whether full clinical trial data is available;
2) all documents related to delayed submission of results will be presented; and
3) members of the public will have a right to appeal any delayed submission of clinical trials results to ClinicalTrials.gov.
Additional detail regarding each of those proposals can be found in the associated pdf at Regulations.gov:

AmR reguationsDOTgov 2015

In a subsequent post, we will present a further examination of legal standards and corporate policies that exist in the U.S. and in the European Union with respect to clinical trial data availability, which will serve to illustrate the potential benefit of each of the proposals cited above.
Posted in Clinical Trials, Featured.

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