Real World Evidence/ Data (RWD) and Post Market Surveillance ( PMS) – Data collection that moves beyond clinical trials and evaluates effectiveness in widespread use of a medical product. Data used for decision making that are not collected in conventional randomized controlled clinical trials
A year or two post-launch, real-world data can provide evidence on the actual effectiveness and economic impact of a new product.
Pharmaceutical and medical device companies will need their health outcomes groups to work more closely with medical affairs to share real-world data as it relates to duration of treatment, disease burden, validated surrogate endpoints, clinical outcome assessments, and quite a number of other health outcome measures. Collaboration between the two groups will be essential.
CHALLENGES: Careful analysis and interpretation of real-world data is critical due to the lack of randomization during clinical trials - the safety picture may change !
The critical key is not the amount of RWD, however, it is the quality of the data. Since this data is collected from a much larger sample size, the challenge of maintaining structure and standardization becomes greater, as the sample size increases. Structured, standardized data is essential, as always, for meaningful analysis of data collected through RWD/ PMS.
Registries – data collected and stored at registries – most typically by ICD or CPT code.
CHALLENGES: Require healthcare providers or others upload/ supply them with data – compliance / obtaining data can certainly be an issue
Registries primarily collect data on a diagnoses – minimal/ inadequate detail on relationship between diagnosis and treatments, no improvements, no complications, etc –only frequency of occurrence- no treatment information – similar to challenges seen with Claims based data.
Enterprise Data Warehouses ( EDWs) - central repositories of data from one or more disparate sources.
CHALLENGES: mass quantities of data, require providers or others to supply the data, This source also has the challenge of no standardization, unstructured data, data contains an extremely large number of unaccounted for variables – all this makes evaluation and analyzation difficult. These are data silos – a large collection of unstructured data – very difficult to aggregate, analyze and prove statistical significance.
Please share your experiences with advantages, disadvantages and challenges to using Real world evidence data, post market surveillance, Registry and Enterprise Data Warehouses for products you work with or your company’s products. Your thoughts and experiences on these methods of data collection and evaluation are extremely valuable to your colleagues in the Medical Data Community