According to Melissa Fassbender in OutsourcingPharma.com, there will be more data generated in the new year than in the last 500 decades. Industry experts say that this information will help to improve clinical trial design and shorten drug development timelines, Fassbender said.
Jackie Kent, senior vice president and head of product at Medidata explained, “We continue to leverage rich data sources and apply analytics and machine learning. These strides allow us to impact the shape of clinical development. Data sharing, through consortiums or other agreements, continues to be a positive impact on scientific insight and patients’ access to trials.
She added, “The industry, as a whole, has the ability to improve on this. Whether it is trial data or commercial data, the more sharing we do across the entire industry, the faster we can provide medicines to patients. Everyone has a stake in that game.”
People are now seeing examples of these advancements. Kent cited her company’s recent collaboration with the Castleman Disease Collaborative Network. This project enabled the organizations to discover novel biomarkers for the rare disease.
Real-world data (RWD) will have a real-world impact in 2019, according to Joe Tyers, senior vice president of sales at Shyft Analytics, a Medidata company. As he said, “From clinical hypothesis generation and outcomes analyses with the medical sciences teams to patient journey and market segmentation in commercial, RWD will become the industry’s data sources of choice.”
Now that use-cases are available, the industry will be able to deliver on “the promise of data,” including from clinical, claims, registry, and electronic medical record (EMR) data, Tyers said. This will “significantly compress the timelines to drug approval and lengthen its time in the market.”
Because more data will be generated in 2019 than in the previous 5,000 years of human existence, managing and using these resources, “augmenting biopharma’s reliance on legacy analytics approaches is at the top of the wish list,” according to Tyers. “At scale, organizations must centralize, integrate and automate data processes — from aggregation and master data management — to produce intelligence at rapid pace.”
To deal with this onslaught of data, digital and analytics partnerships are increasingly emerging among contract research organizations (CRO). While Tyers believes that “tech partnerships across large- and mid-market CROs will drive mission-critical innovation,” when compared to other industries, life sciences lags in areas of digital migration, such as enterprise cloud adoption and artificial intelligence (AI), among others.
“By neglecting to incorporate technology and depending solely on professional services, clinical and commercial activity is reduced, and the pace of industry innovation is slowed,” according to Tyers. Still, the advancement and approval of specialty and rare disease therapies continues to accelerate at “a fantastic pace.” The growth of prescriptions for orphan drugs was nearly twice that of the overall pharmaceutical market in 2018. He concluded, “Innovation is alive and well in these areas of critically unmet need with products in this space, accounting for more than one out of every five prescriptions written worldwide by 2024.”
The use of commercial data and insights also impacts clinical development. Kent thinks that enables customers to have more health outcome information. This need to connect clinical and commercial data prompted Medidata to acquire Shyft. Customers also want to learn more about the patient burden. Kent added, “Patient centricity as a way of improving patient outcomes will continue to be the goal for the industry in 2019,” said Kent.
While companies such as Medidata are using more and more data to ensure patients have access to a trial best suited for their disease, and one that was designed with their needs in mind, patient recruitment will continue to be challenging in 2019. Kent thinks that everyone is trying to do better, but there is room for improvement.
She concluded, “This very old problem continues to be an issue that slows down getting new medicines to the market. We have seen progress with virtual trials and with the introduction of new sources to capture patient data, but this challenge will still exist in 2019 and is something we will all be actively working on.”