A life-saving Covid-19 vaccine made by Pfizer and modern been developed and clear The request by the Food and Drug Administration comes just 11 months after the U.S. classified the spread of the disease as a public health emergency. The dire circumstances of the pandemic have driven this rapid timeline, as well as the pioneering use of mRNA technology by drugmakers.
The speed of these vaccine trials should inspire the pharmaceutical and medical device industries to accelerate the decentralization of their clinical trials, Shweta Maniar, Google CloudDirector of Healthcare and Life Sciences, wrote in a company blog post on Wednesday. Harnessing real-world data will enable faster clinical trials of all treatments and devices, she believes.
Real-world data refers to information on health outcomes for different populations living in real-world settings. This data often comes from a variety of sources, such as EMRs, patient surveys, and claims submitted to payers. Because the collection of this heterogeneous data can paint a picture of health outcomes in a broad population, it may one day be able to replace placebo groups in clinical trials, Maniar said in an interview.
“Companies are looking to apply real-world data in clinical trials so that in the future, you don’t even need a placebo,” she said. “You get enough historical information from real-world evidence to support the component.”
When clinical researchers use real-world data, they can look at more data from more people, potentially deepening their understanding of how disease behaves in the body and how different populations are treated. The automated collection of this data enables researchers to conduct clinical trials on more efficient timelines — the longest-consuming element of the pharmaceutical and medical device supply chain.
Real-world data is collected remotely, so it also allows researchers to include more participants in their trials. PwC in November study 67% of Americans said they would be less likely to participate in a clinical trial if they were asked to travel to a research site outside of their local area. This gives drugmakers and device makers the opportunity to bring clinical trials from hospitals and universities to a virtual environment.
Some startups are built purely on the potential of real data to accelerate and scale clinical trials.One of them is ediblea decentralized clinical trials company with improve Valued at $521 million since its inception in 2012. The startup’s software makes it easier for drug companies to obtain consent from trial participants remotely, provide telehealth access and leverage data from remote monitoring devices. Wire is another prominent player in the use of real data in the decentralized clinical trial space. In March, the company cooperating and AWS Help scale and embed more predictive analytics into its real-world data platform.
CVS is one of the most famous join in Last year’s decentralized clinical trials movement. The health giant launched a clinical trials business to help drugmakers and contract research organizations recruit patients for research. The company said it spun off the company to help address concerns about low enrollment and a lack of diversity in clinical testing.
Google Cloud has also developed a solution for real-world data management of clinical trials. In 2019, the company released real world insights It is a platform co-developed with the FDA.The platform is based on FDA MyStudiesthe agency’s open-source real-world data platform for clinical research.
Real-world data platforms from Medable, Thread, CVS, and Google Cloud can help drugmakers and device makers increase trial enrollment. Life sciences companies should consider incorporating these platforms into their research as early as possible, Maniar said, because no one can predict when the next pandemic will arrive, and there is an urgent need to decentralize trials.
Photo: elenabs, Getty Images
