Precision medicine stands at the forefront of medical innovation. The growing focus on developing new drugs based on specific genetic biomarkers promises to revolutionize treatment, including in major fields like oncology, and improve outcomes for patients all over the world. In 2017, 35% of all new drugs approved by the FDA were personalized medicines, and many expect this number to continue growing.
Developing side-by-side with precision medicine is companion diagnostics. These tools, often in vitro devices, identify biological markers and provide essential information on the safe and effective use of a corresponding drug. They’ve become more advanced recently, with the FDA approval of the use of liquid biopsies to detect tumor cells in cases where there’s a lack of available tissue to run a traditional companion diagnostics test.
For the diagnostics industry, companion diagnostics represent a major opportunity to get involved with precision medicine and the innovation flowing from it. And in an exciting twist, regulators are showing some excitement for it. In 2018, the FDA demonstrated further commitment to advancing efficient co-development of drugs and in vitro diagnostics. The FDA has released several guidance documents for sponsors, including a guide that encourages early co-development of drugs and companion tests. New regulatory processes will allow a more flexible pathway to transition a clinical trial assay into a validated and FDA-approved companion diagnostic.
Currently, there are more than 1,100 oncology products are in various stages of development and 73% include biomarkers. With growing regulatory enthusiasm from the FDA, how can diagnostics researchers ensure they have the ideal technological resources to capitalize on this opportunity?
Choosing the Right eClinical Tools
Over the years, eClinical tools have developed a vast array of features to suit a wide variety of industry needs. While some capabilities like faster study build can benefit all researchers, others can make a big difference specifically in diagnostics trials. For example, these trials often use multiple dispersed sites and need to capture data lightning fast. Having tools that allow researchers to efficiently capture data on a tablet with or without an Internet connection can smooth the research process and save hours of additional work. On top of this, being able to share and access all study data from tablets at different sites empowers researchers to stay on the same page and keeps the research flow fast and seamless.
As regulatory doors continue to open in precision medicine and companion diagnostics, fast and flexible eClinical tools can accelerate and maximize their positive impact. Additionally, as these markets continue to grow, it’s likely that competition will rise – greater speed will be necessary to maintain a competitive advantage and stay at the cutting edge of research. Finding specific eClinical features that best fit trial needs facilitates better outcomes and ensures that innovative products reach the market faster, helping populations in need to have higher qualities of life.