When health becomes personalized
The advent of precision or personalized medicine is introducing ‘individuality’ in the world of health. Precision medicine works in contrast to the ‘one-size-fits-all’ approach and focuses on individual variability in genes, environment and lifestyle. The blood transfusion of a specific blood group to a distinct patient rather than any random group demonstrated the personalization of medical treatment in the past. However, personalized medicine today is more inclined towards the characterization of individuals based on their genome, proteome, microbiome – ‘to be very precise’ to develop specific therapies and deliver treatments effectively.
RWD in precision medicine
Traditional clinical trials are dependent on large cohorts of patients sharing the same condition but disregards the role of genetics or etiology. The natural history of disease is not same for all the patients as it varies according to the environment and the heredity factors. Hence a drug that gets tested in a trial however might not be applicable to all patients afflicted with the condition due to dissimilarity in the genetic makeup. This might be one of the reasons of drug failure in certain candidates participating in the trial and inconsistent efficacy across all the patients in the real-world following approval.
RWD on the other hand could provide a better approach towards precision medicine as it could help in informed decision making.
- RWD can provide information on the effect of therapies in real-world patient populations and this data is more valid than those from clinical trials. This is particularly significant in precision medicine, as it is imperative to understand the factors that have an impact on the response of the treatment that is less likely to be captured in a clinical trial.
- Linking RWD with genomics and other data points can result in formation of a study population with dissimilarly-similar characteristics. This population can help generate evidence for tailor made interventions.
Accessing RWD for precision medicine
RWD can be retrieved from biobanks and disease registries. Other sources include
- prescriptions,
- insurance claims,
- Electronic Health Records (EHRs),
- laboratory tests,
- clinical notes,
- wearables,
- patient self-reported data,
- surveys
- social media.
These platforms provide diverse real-world health data from an extensive range of patients and volunteers.
RWD with precision medicine and pharmaceuticals
Organizations specializing in RWD analytics are the need of the future.
RWD is also very helpful in capturing data related to drug compliance in a population, medical costs and outcome. Such information can be integrated to monitor and extract specific health measures related to a drug to validate efficacy and demonstrate their products’ value to payers.
RWD insights can be used for improved understanding of the product market in terms of competition, pricing and market share.
Author:
Senior Scientific Associate
phamax
