The US Food and Drug Administration (FDA) is making $2 million-worth of funding available for a project to develop data standards for studies of lipid-modifying drugs, and therapies for diabetes and hepatitis C.
The money will be used to support an initiative set up last year called the Coalition for Accelerating Standards and Therapies (CFAST), which has the aim of providing a framework to help FDA reviewers assess new therapies more efficiently.
The FDA’s Centre for Drug Evaluation and Research (CDER) is receiving an “enormous and growing amount of data” but a lack of standardisation “creates significant challenges”, says a Federal Register notice announcing the funding.
CFAST is a public-private partnership (PPP) set up by the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) to develop global standards used to report data from clinical trials for certain priority therapeutic indications.
When the initiative was set up last, CDER Director Janet Woodcock described the need to develop “definitions” for individual diseases and the therapeutics used to treat them, noting that this could potentially speed the delivery of new therapies to patients.
“Standardised data elements that are common to all clinical trials, such as age and gender, have been established through CDISC standards,” says the FDA.
“However, data elements that are unique for a particular disease or therapeutic area still need to be developed so that the data are consistent and consistently understood for efficacy analysis, and that data from multiple trials can be more easily grouped for reporting and meta-analysis,” it adds.
In addition to lipid, diabetes and hepatitis drugs, the project will also have the task of developing standards for studies of drugs which may affect the QT interval on an electrocardiogram (ECG).
Some pharmacological agents are known to prolong the QT interval, posing a significant health risk to patients, and since the late 1990s around half a dozen drugs have been taken off the US market as a result of this side effect.
The award will be given to a research group operating under the C-Path umbrella, an organisation which includes more than 1,000 scientists from government, academia, patient advocacy organisations, and 41 major pharmaceutical companies.
