Intelligent RWE: The bridge of Evidence

Glossary: RWE – Real world Evidence, RWD -Real world Data, SaMD – Software as a Medical Device, EHR – Electronic Health Record, NLP – Natural Language Processing, IOT – Internet of Things

Startups are aspiring and inspiring insanely to eliminate diseases through technology. Medicine will probably advance in next decade. But then why bringing drug has a controversial price tag of over $2.7B (per Tufts study), and at large pharma R&D returns have dropped to under 2% in 2018?

Maybe because? From the R (discovery) to D (development) the biopharma is still stuck in the same old same old. 

Today consumers are gaining control, regulatory barriers are getting challenged and collaboration is the buzz word. The sheer deluge of data lakes - Health records, insurance claims, wearables, apps as a platform and the newbie – genomic linked data, is gobbling the pharma and drug development.

So, what’s the answer: SaMD? RWE? SaMD will take time but RWE, absolutely. Amidst the new therapies and smart medical devices, patient safety and R&D productivity can be accelerated by harnessing the RWD to generate powerful and inteligent RWE. RWE can be the bridge to innovate R&D decision making, clinical trials design, drug discovery and development. It surely can be a bridge to empower and differentiate across the value chain – Patients, Payers and Providers.

Per FDA guidelines RWE can be used to provide evidence in support of effectiveness or safety for new product approval or even for supporting any labeling changes (modify, change in dose, new population, addition of safety or comparative info) for an approved product.

Then why it’s not hot? RWD comes from disparate sources including EHRs, Medical claims, billing data, disease registry, mobile, social and patient generated data from wearables and IOT. This brings major obstacle in terms of silos, specific/limited audience, limited purpose & highly unstructured content, data governance, data security (residency) challenges laced with incomplete analysis and options. Overall current system in not efficient in collecting, integrating and analyzing the data for valuable insight driven decisioning.

Alright. How to…? Unleash the power of digital – Platforms and analytics across connected devices, mobile apps. It’s time to build platform as a point solution for patients & investigators to discover, access, share, monitor and track data seamlessly. First remove data silos between clinical data, quality & outcome data, administrative & operational data and patient reported data. Build a standard taxonomy across diverse data sources. Source global information, build the bridge across data sets to slice and dice problems to achieve cheaper-faster-better R&D. Second integrate and harmonize data. Third layer in analytics and insights engine through Cognitive and artificial Intelligence, NLP etc. Lastly wrap all with data governance, assurance and privacy algorithms to achieve a 360 view.

Is Industry ready? Life-sciences as an industry is pretty behind in the digital wave. Both the Lifesciences organizations and governing bodies are still in phase of incremental improvement in safety and time to market. As the industry gears for disruptive innovation maybe it’s time to move away from long established hubs across biopharma. An intelligent RWE is definitely the bridge to connect the community to aid randomized or pragmatic clinical trials and observational studies.