The lifecycle of drug development, right from moment of conception till the time its approved for widespread usage, is an extremely long & complex one. The amount of data generated through trials or acquired from various points of collection, which is required to be analysed during this process is humongous. For a drug to be effective, the patient data which forms the foundation of its development, must closely reflect the conditions of the demographic or section of people it is intended for.
This is where, Real World Data (RWD) & Real-World Evidence (RWE) come into play. With high levels of technological integration in our daily routines, various new avenues such as different types of wearables & smart devices are emerging as accurate sources providing crucial healthcare data over extended periods of time. Let us understand how the transformation of real-world data into actionable real-world evidence is impacting modern medicine.
What is Real World Data (RWD) ?
Prior to a drug’s approval, a number of rounds of randomized control trials (RCTs) take place to prove the efficacy & safety of the drug. More often than not, these are bound to miss more than a few demographics such as those with specific illnesses or parts of a population located far enough to not be included. This can sometimes be harmful as the effects of a drug cannot be guaranteed on that demographic. Real World Data is therefore any medical data collected from sources apart from RCTs such as:
- Electronic Health Records
- Case Reports
- Insurance Claims
- Public Health Registers
- Data from smartwatches or wearables
- Patient reported outcomes
How is RWD transformed to Real World Evidence (RWE) & What is the purpose behind it ?
RWD provides an opportunity to access a plethora of previously untapped data points for the healthcare ecosystem but with robust analytical tools it can be churned into actionable insights referred to as Real World Evidence. The FDA defines RWE as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.”
RWE allows us to bridge the gap between the expected outcomes (such as those discovered through clinical trials ) & what actually occurs in real life conditions. To eventually improve the standard of medical care & the efficiency of drugs and methods of treatments, we need to be able to understand how these medicines are impacting people across age-groups & demographics in uncontrolled environments (daily life).
Scenarios of RWE Benefitting Medical Processes :
- Pre-Trial Study Design helping researchers
identify the best set of potential patients while allowing maximum variety of
possibly affected demographics.
- Market surveillance – Once a particular drug is
in widespread use, RWE can help doctors, researchers, regulatory bodies, pharma
& insurance companies accurately understand its effectiveness, side-effects,
and safety aspect.
- Fill in the inherent blind spots existing in the
framework of clinical trials. Clinicals trials, albeit extremely crucial,
cannot guarantee the effects of a drug on the entire spectrum of population as some
demographics will always not be part of those trails, due to lack of availability
or certain trial requirements. RWE can help to understand how an unapproved
drug could impact people with a certain set of pre-existing health conditions.
- Comparative studies can further grow & help
in the adoption of targeted therapies as RWE allows healthcare professionals to
decide the best course of treatment optimally & uniquely for any particular
- Real word evidence can used as a comparative tool
to measure the standard of medical provided by a list of facilities and can
help find areas of betterment, be in terms of personnel, infrastructure, equipment,
or drugs used.
Why is Real World Evidence (RWE) gaining attention now ?
Major leaps forward in the quality of technology & equipment at our disposal has helped propel spotlight on RWD & RWE. The adoption of smart tracking devices and wearables clubbed with state-of-the-art tools for big data filtration & analytics has facilitated the surge of utilizing RWE.
Throughout the pandemic, physical monitoring of patients also became highly difficult and hence data from electronic devices & records (RWD) allowed the healthcare system to remain collected & progress forward further showcasing the importance of RWE.
As the ripples of technology begin to impact remote corners of the world, the applicability of Real World Data & subsequent translation into Real World Evidence will become increasingly important with the passage of time.
The 5th Annual MarketsandMarkets Real-World Evidence and Life Sciences Analytics Conference scheduled for the 20th-21st October 2022 will delve deeper on how the healthcare ecosystem is harnessing the power of RWE in the forthcoming years.
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