5:00 PM
 | 
Sep 07, 2018
 |  BioCentury  |  Product Development

Data distribution

How TransCelerate’s clinical data sharing platforms are improving clinical development

TransCelerate BioPharma Inc. is taking its data sharing initiative to the next level with a new platform that will integrate clinical and preclinical data sets in a single repository and provide new analytical tools. DataCelerate, a data-sharing platform launched in July, will initially provide insights into the causes of toxicological findings.

The platform currently contains in vivo preclinical toxicology data. Once TransCelerate migrates its clinical data into the new platform, companies should be able to use the combined data to improve the predictive power of their preclinical studies.

TransCelerate is a precompetitive consortium of 19 companies working on multiple initiatives to resolve clinical trial bottlenecks. In 2015, it announced the Placebo and Standard of Care Data (PSoC) Sharing initiative to collect and share de-identified patient-level data from the control arms of clinical trials conducted by the consortium’s members. The PSoC repository now contains data from placebo and control arms from more than 130 clinical studies spanning nearly 20 therapeutic areas. Data are available only to member companies that commit to contributing data.

TransCelerate said in an emailed statement to BioCentury that 15 of the group’s member companies have signed the data sharing agreement that gives access to the database, and that “the majority of adopting member companies are frequently using the data to design clinical trials.”

The member companies that have disclosed how they are using the database report that it has helped them use fewer patients in their clinical programs, assess background rates of adverse events, and assess the influence of confounding factors.

“The reference outcome rate you determine in your comparator group isn’t as captive to chance.”

Elliott Levy, Amgen

Elliott Levy, SVP of global development at Amgen Inc., said the biotech has used TransCelerate data to supplement the control groups in Phase II studies of three products for inflammatory indications. Doing so allowed Amgen to enroll fewer patients in the trials’ comparator arms.

Levy said bolstering the trials with additional controls also could mitigate the effects of a placebo group that performs better or worse than expected. “The reference outcome rate you determine in your comparator group isn’t as captive to chance as the rate you might observe in a smaller randomized group of patients,” he said.

TransCelerate...

Read the full 1843 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >