New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.
The FDA is calling on the digital health industry to innovate and proposing a new Center of Excellence for Digital Health – the timing of which is critical, as the industry is receiving more funding and opportunities than ever before, says industry exec.
Iqvia says its collaboration with Genomics England will help drugmakers and academics draw insights from clinical-genomic datasets – the ‘future of real-world research.’
TriNetX is releasing a series of new tools that will enable more people to conduct health research on their own, with access to rich datasets and analytics, says VP.
Cytel examines the gap between controlled experiment and real-world data at a time when the industry is collecting more data from more sources than ever before.
Taking inspiration from popular games such as Candy Crush and World of Warcraft, Data Cubed has developed a mHealth platform that promises to increase patient engagement in clinical research.
The top three myths of ‘going digital’ relate to the industry’s self-image, the perceived role of technology, and current market conditions – still, digital is not a fad and is here to stay, says industry expert.
Virtrial’s vision is to replace up to half of the standard clinical trial visits with virtual ones, using a hybrid approach incorporating telemedicine.
Robotics and automation will help improve the clunky and expensive clinical trial process, says Icon CEO – as the company continues to evaluate potential opportunities to improve efficiency.
CTTI’s latest recommendations will help researchers deploy mobile technologies in clinical trials and “pave the way for improving how we develop medicines,” says Pfizer exec.
The industry needs “to strike a balance” between science and feasible execution as increasingly complex clinical trial protocols are impeding efficiency and driving up costs, says industry expert.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
