The stakes are high: large risks and the potential for huge rewards are deeply rooted in pharmaceutical research and development. Each year billions are spent exploring the capabilities of novel compounds, yet most of them never make it to market. And since the industry employs a cost-recovery model for R&D, there is an increasingly complex landscape in which getting a return on investment is more difficult.
Outsourcing to Contract Research Organizations (CROs) is one way the industry has responded to rising costs. This trend is expected to increase to 50% by 2020 – up from 37% in 2013, and many of the largest pharma sponsors now contract out 100% of their laboratory services. However, CRO-sponsor relationships can become complicated at times, and getting stable investment returns remains challenging:
Despite these challenges currently facing pharma R&D, the industry is seeing a wealth of opportunity. Digital remedies from AI to social media are getting stronger support from regulators and are showing increasing potential to streamline trials and enhance CRO-sponsor collaboration. We see this time as a pivotal moment to revamp workflows to keep up with the shifting clinical trial landscape – and those who adapt fastest will reap the rewards of a more efficient R&D process. The results could mean a bigger impact on public health and better returns on research investments. Here are just a few examples of how new tech can help:
Low adherence can seriously harm researchers’ abilities to measure outcomes. It’s estimated that 20-30% of trials fail due to adherence issues, delaying novel treatments, and hurting ROI. There are several emerging solutions aimed at improving this situation:
One company has created an AI facial recognition app that monitors adherence by having participants take selfies to prove they’ve taken the prescribed medication. It has markedly improved researchers’ ability to ensure that patients are following protocols.
Since pharma companies manage massive amounts of data often from multiple labs and trial sites, there is a push for more central, real-time clinical trial monitoring to accelerate safety and decision-making. AI shows promise for organizing these large data sets rapidly.
eClinical platforms have become a necessity to adapt to the needs of modern clinical trials. Electronic Data Capture (EDC), Direct Data Capture (DDC), and RTSM are solutions that also hold great potential to improve CRO-sponsor relationships and ROI:
Real-world evidence (RWE), including electronic medical records, genomics, social media, and wearables, is viewed as a game-changer for the way pharma evaluates the safety and efficacy of new therapies. It also holds the promise of reducing patient recruitment struggles that can increase trial costs and timelines.
These examples just scratch the surface of new applications that can lead to higher investment returns. And during this transitional period where outsourcing becomes the norm and technology integrates into many aspects of the research process, it’s important to keep in mind that we’re all working together towards the common goal of preventing, detecting, and treating disease. Even as we get further apart geographically, technology provides novel pathways for collaboration that can improve the quality of new treatments, decrease the time and cost it takes to get them to market – and have a far-reaching positive impact on both public health and ROI.