Real World Data (RWD)

Real World Data is a by product of the everyday usage of products by patients. These data can be collected via various channels such as patient registries, electronic health records, insurance databases, social media, patient research networks etc.

Randomized CT data is still the gold standard for drug development, however RWD is gaining much attention from past decade from the regulator’s perspective.

RWD offers meaningful insight into diverse populations, the amount of data collection would be voluminous in a short span of time. The RWD collected in a post marketing stage can augment the value to the CT Data

Real World Evidence (RWE)

Real world evidence is a derivative of RWD or on observational data outside the context of Randomized CTs. The RWD would be analyzed and the impact of the same will be studied from the perspective of Product Benefit – Risk Ratio there by enhancing the drug safety.

RWE will play a significant role when randomized CTs cannot account for the diverse global population. The patients who cannot participate in the trials as they might be residing in distant part of the world or due to age limits / comorbidities and who has taken the product in the post marketing phase will be counted in this kind of study.

The RWE helps the pharmaceutical companies and insurance payers to assess patient pathways to deliver appropriate care and lowering the financial risks.


Challenges with this approach

The end to end (length, breadth and depth) data which is a strength, is also a challenge on using this approach. There is no standardization both in terms of data entry or the type of data collection. Privacy and confidentiality of the data is a key issue while deriving the pre-history of the patients associated with the data collected. Inconsistent usage of terminology followed in the pharmaceutical verbiage is another issue too.

Regulatory Expectations

FDA has created and issued a framework in order to standardize the any RWD. The technology (My Studies App) allows to take data from various source and provides means to measure and standardize the data. The objective of this technology is to facilitate the inputs of RWD into one platform and they can be reverse linked to the source from where the RWD was derived for e.g., EHR / Insurance DBs etc.

Apart from the data collection provision from Regulatory authorities, various private parties do have platform which offer analytics which would aid toward unseen insights on clinical trials progress, Adverse events and study outcomes. This approach helps in supporting efficacy and safety of both the drugs and therapies, thereby saving more lives