TUCSON, Ariz., May 5, 2015 — The non-profit Critical Path Institute has been selected to host a new tuberculosis (TB) clinical trial data sharing platform. The initiative will start by creating a common database from three Phase III clinical trials earlier supported by the Special Programme for Research and Training in Tropical Diseases (TDR), the TB Alliance and St. George’s, University of London.
“This is the first time trial sponsors have come together to make clinical trial data collectively available,” says Piero Olliaro, head of Intervention and Implementation Research at TDR. “Choosing the hosting organization is the first step. In the next few months we will be working together to format the data so that they can be accessed and used for further analysis.” Randomized, controlled TB clinical trials are lengthy and costly, but this platform is designed to speed up data analysis through this sharing. To start, researchers will be able to mine patient-level data from the OFLOTUB, REMoxTB and RIFAQUIN clinical trials. Other trials are expected to be added in the future.
“For research in areas like tuberculosis, where there is no financial incentive, we must work together to advance the field,” says Mel Spigelman, MD, President and CEO of TB Alliance. “This collaboration and data platform will enable donors’ investment to go further in helping to tackle the TB epidemic and bringing researchers from around the globe together to solve one of the world’s most intractable public health problems.” C-Path was selected through a competitive proposal submission process. It is a non-profit institute and recognized expert in database development, data standards development, secure management of patient-level data, individual privacy, database security and controlled access methods. In this role, C-Path will host, curate and make key Phase III TB clinical trial data sets available to qualified researchers. C-Path has 10 years of experience with the design and implementation of global data platforms in nine major disease areas, representing data from more than 30,000 patients.
“This is a welcome extension of one of C-Path’s core competencies,” says C-Path CEO, Martha Brumfield, PhD, “and with this collaboration, we are positioned to further enable meaningful learning from clinical trials in TB. Ongoing collaboration and data sharing across multiple organizations is critically important if we are to develop the necessary new regimens to fight this deadly disease.”
The groups expect to make the platform open to interested research groups by the end of the year.
For more information, contact:
At TDR: Piero Olliaro
olliarop@who.int
At C-PATH: Kissy Black
kissyblack@lotosnile.com
+1 615.310.1894
At TB Alliance: Joanna Breitstein
Joanna.breitstein@tballiance.org
+1 917.842.8416
At St. George’s Hospital: Dr. Amina Jindani
ajindani@sgul.ac.uk
+4420 8725.2810
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