RWE: A Growing Need for Innovations in Healthcare Research
Real-world evidence (RWE) research is becoming increasingly important for biopharmaceutical product development, commercialization and lifecycle. According to Deloitte’s Real-World Evidence Benchmark Survey, 54% of interviewed Life Sciences companies are investing in their RWE programs to significantly increase their presence and opportunities in a big data world. Many are targeting the use of RWE to support R&D in areas such as improving trial design and patient recruitment.
Real-world evidence is an area of methodological innovation that is generated by merging multiple sources of patient data (clinical data, genomic data and socioeconomic data). Compared to clinical trial data, RWE data more closely describes how the product will perform in a broader, more representative population over a longer timeframe. In addition, it provides information and outcomes that are not part of the clinical trial protocol. Analysis of such outcomes from the use of innovations in real world settings generates a further insight into safety and efficacy. And thus, this is a big step towards making healthcare more personalized and effective in responding to individual patient needs.
Among the potential barriers to accessing the right data for RWE, experts primarily highlight the following:
Data quality — especially from non-traditional sources.
- Cost — the cost of collecting and maintaining data from non-traditional sources such as patient groups, professional societies and healthcare providers is uncertain.
- Regulatory framework — to date, manufacturers have special opportunities and face special restrictions when using RWE.
- Patient protection — data breaches in the healthcare industry continue to raise concerns around the security and privacy of patient data. These concerns could stifle the willingness of institutions to invest in RWE applications or of patients to consent to the use of their data.
Talking about application of RWE, we have seen the potential to support all phases of the innovation process in healthcare: clinical research, pre-regulatory approval and post-approval.
We were the local market disruptors who first introduced clinical data management solutions into the Russian market, by training local players and moving the industry onto digital platforms. Now we are on the verge of another breakthrough: introducing the potential of real world evidence to pharma. RWE will likely serve as the benchmark for clinical trials in the future, therefore this is where our main focus lies. — Ekaterina Krinitsyna, Head of Business Development at DM RWE.