The following is a guest blog post by Julie Krommenhoek from Ciox.
Non-Small Cell Lung Cancer (NSCLC) is a designation that accounts for more than 80 percent of lung cancers diagnosed, and it has emerged as a new hotspot for investment by pharma manufacturers. Globally, the NSCLC therapeutics market is expected to rise to a valuation of US $15.1 billion by 2023, with pharma giants like Novartis, Pfizer, AstraZeneca, BMS, Celgene, and Genentech actively working to bring new drugs to market. Moreover, more than 700 research organizations have at least one cancer therapy in late-stage development, with most of the largest pharmaceutical companies dedicating at least one-third of their late-stage research and development activity in oncology.
As pharma doubles down on cancer, the launch environment for these drugs is drastically changing too. Advances in regulatory environments and the use of information will together act as driving forces to impact oncology treatment and costs over the next decade. Where NSCLC can take off next is where regulation, data, and pharma collide.
Shifting Regulatory Environment
On the subject of regulation, several significant changes are afoot. The National Comprehensive Cancer Network (NCCN) has traditionally kept pace with accelerating research and associated trends in oncology and recently (in February 2019) updated its treatment guidelines to support the deluge of new data on targeted and immunologic treatment of lung cancer. NCCN today supports the use of broad medical data in the fight to cure lung cancer.
The FDA meanwhile has unveiled its Real-World Evidence (RWE) framework to provide a high-level view of how it is looking at the use of real-world data. The scope of the FDA RWE program broadly includes evaluating the potential use of RWE to support changes in labelling drug product effectiveness.
In continuation of FDA’s acceptance of RWE, CDER (Center for Drug Evaluation and Research) also in March 2019 divulged its preparation of three guidance documents supporting RWE and RWD with an aim to make these guidelines public before the end of 2021.
This increasing regulatory acceptance for RWE sets the stage for oncology markets to make use of real-world data sets, and improves outcomes on the back of extensive pharma investments and improving data technology.
Enter Real-World Evidence – the crucial game changer
What pharma needs today is to harness RWE capabilities to navigate the complex treatment landscape, intense competition and rising cost pressures to provide RWE and analysis capabilities more seamlessly. The ability of RWE to quickly establish hypotheses and test their statistical evidence is changing the face of research and development. The pharmaceutical industry is entering an era where RWE can be used to answer what works, for whom, in what context, and at what cost. Increasingly, data and evidence are being generated by biopharmaceutical organizations, from drug discovery through commercialization.
To successfully understand what treatment works for which patient and in what context, the real-world data needs to be representative of the overall population as well as the desired sub-populations. It needs to be deep enough to understand each patient, longitudinal enough to gain full context, and comprehensive enough to not miss the nuances of which treatment was provided when resulting in what outcome.
As researchers explore different sources of real-world data, they are finding one key drawback: most existing data sets have been developed for operational and financial considerations (often for insurance companies) and thus quickly face attrition when getting relevant patient data. As non-relevant data sets are parsed out from the rosters, sample sizes quickly drop from 10,000 to less than 100 when the data quality bar rises.
How “Better Data, Faster” Will Help Pharma Stay Ahead of the Race
From a pharma industry perspective, it’s not about what they need (that’s RWE), but how they get it. The answer is better partnerships and collaborations that provide them with quality real-world data at a faster pace.
The framework for acquiring and building better data sets exists today: As health data companies already provide the release of patient information across insurance, provider and life science concerns, vast amounts of real-world patient data flow through such organizations. By better categorizing, framing and tracking this data, real-world data sets become buildable to the pharma industry at the drop of a hat with the use of data structuring technologies and artificial intelligence.
It’s all about equipping researchers with real, de-identified data which contains clinical information, aggregated from consented health data. By offering structured, standardized real-world data from RWE to validate hypotheses and identify cures, health data organizations can partner with the pharma industry to expedite the acquisition of health data to meet research parameters. It’s better data, faster.
With many billions on the line as the NSCLC market and broader oncological market mature, and with major breakthroughs (and windfalls) over the next treatment horizon, now is the time for real-world evidence to play a much more significant part in the next generation of life-saving medicine.
Ciox, a health technology company and proud sponsor of Healthcare IT Today, is dedicated to significantly improving U.S. health outcomes by transforming clinical data into actionable insights. Combined with an unmatched network offering ubiquitous access to healthcare data, Ciox’s expertise, relationships, technology and scale allow for the extraction of insights from structured and unstructured clinical data to create value for healthcare stakeholders. Through its HealthSource technology platform, which includes solutions for data acquisition, release of information, clinical coding, data abstraction, and analytics, Ciox helps clients securely and consistently solve the last mile challenges in clinical interoperability. Ciox improves data management and sharing by modernizing workflows and increasing the accuracy and flow of information, while providing transparency across the healthcare ecosystem and helping clients manage disparate medical records. Learn more at www.ciox.com.