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 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 remain challenging:
• According to a Deloitte report, the average cost of a biopharma clinical trial has nearly doubled from 2010-2017. Clinical trial challenges such as patient adherence are cited as contributors to surging price tags.
• Peak sales have not increased to offset higher costs. R&D returns are down from as much as 10.1% to 3.2%, and the industry is under continued pressure to keep prices low.
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:
AI for patient adherence and monitoring
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. From EDC to direct data capture, these platforms also hold great potential to improve CRO-sponsor relationships and ROI:
• With the EMA’s recent qualification opinion on direct data capture, regulators have signaled support for technology that has the potential to give CROs, sponsors, and other stakeholders greater transparency and the ability to collaborate more effectively.
• Our research also shows that through reduced monitoring and increased data quality, direct data capture can lower clinical trial costs by as much as 30%.
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.
• RWE helps demonstrate drug effectiveness beyond the clinical trial setting and helps pharma companies provide evidence on improved patient outcomes and healthcare system efficiencies.
• Many leading pharma companies are already boosting RWE programs.
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.