• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

Johnson & Johnson Will Share Clinical Trial Data

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
From Physician's First Watch

Johnson & Johnson Will Share Clinical Trial Data
By Larry Husten

In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson has announced that it will make all its clinical trial data available to outside researchers. The company said that the Yale University Open Data Access (YODA) Project will serve as an independent third party "to review requests from investigators and physicians seeking access to anonymized clinical trials data."

Johnson & Johnson said the program "is the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data."

"This is a remarkable action ... that should accelerate the movement of the clinical research enterprise toward more cooperative learning and sharing," said Harlan Krumholz, leader of the YODA Project and Editor-in-Chief of NEJM Journal Watch Cardiology. "By establishing this fair and independent process to release data, Johnson & Johnson has taken a leadership position in this emerging era of open science."

Adapted from CardioExchange

Link(s):
J&J press release (Free) http://click.jwatch.org/cts/click?q=227;67954792;Z4lijkq5oH3GW8HnL6X2siBa5pfPbeI0e3JnXsVHves=
YODA project (Free) http://click.jwatch.org/cts/click?q=227;67954792;Z4lijkq5oH3GW8HnL6X2si417lFONXERe3JnXsVHves=
CardioExchange (One-time registration required) http://click.jwatch.org/cts/click?q=227;67954792;Z4lijkq5oH3GW8HnL6X2so2bgSF9RDlJe3JnXsVHves=
 

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
Good article from the New York Times:
Give the Data to the People - NYTimes.com
[OK, so not actually giving the data to the people, but giving researchers the chance to apply for the data to an independent third party - which should stop the orginal researchers from simply blocking access to those whose views they don't like.]

... Everything in the company’s clinical research vaults, including unpublished raw data, will be available for independent review.

...Even when studies are published, the actual data are usually not made available. End users of research — patients, doctors and policy makers — are implicitly told by a single group of researchers to “take our word for it.” They are often forced to accept the report without the prospect of other independent scientists’ reproducing the findings — a violation of a central tenet of the scientific method.

The piece (written by the independent third party holding the data) adds about researchers fear over sharing eg
...that lawyers will take advantage, that incompetent scientists will misconstrue the data and come to mistaken conclusions. Researchers feel ownership of the data and may be reluctant to have others use it...The more we share data, however, the more we find that many of these problems fail to materialize.
Then comes the example of Medtronic, a licensced bone stimulating product that had had its original data analysis queried. The manufacturers then released all the data and Independent reviews were commissioned:
Interestingly, the reviews produced somewhat conflicting results. One found that the device was no better than a bone graft and might be associated with a slight increase in cancer, while the other found that the device was effective and the cancer risk inconclusive. To us these differences reinforce the value of open science: now the data are out there for further study.

Of course, I think of the CFS PACE trial and the reluctance to make data available to anyone because of fears the data would be 'misused'. Perhpas the PACE authors would consider releasing ALL the trial data to a third party for independent review? It could take a lot of the heat out of the situation.