Randomized Clinical Trials (RCTs) gather clinical data from a small and limited set of samples. It is increasingly being challenged by the payers and healthcare providers as a method to measure the safety and efficacy of drugs. Since the data gathered from RCTs are obtained in a highly controlled environment over a short period of time, it fails to acknowledge special cases and conditions. The players from wellness ecosystem are looking for a much larger set of real-world data which accounts for all possible variations and special cases and conditions to validate drug safety and efficacy. Real world evidence uses observational data such as patient registries, electronic health records, social and web data, and patients claim data to generate insights and predictive findings on drugs, diseases, and patients.
Real world evidence is a powerful analytical tool which can indicate the effectiveness of the drug under various conditions. Apart from this, there are various other reasons why pharma firms are heavily investing on real world evidence:
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Cost Savings and Increased Returns
The best practice medical research methodology of RCT is very expensive and time-consuming. Apart from the cost of carrying out the trial multiple legal compliance issues needs to be addressed. Real world evidence can be delivered at a relatively low cost as it eliminates dodgy results of clinical drug trials which increase the R&D costs.
Support Value Demonstration and Safety Claims
Real world evidence can support regulatory approvals on the safety and efficacy of new drugs and medical devices by augmenting RCT data. It provides real world data on the effectiveness of the new drugs and supports the safety claims regarding FDA’s accelerated approval programs. Also, it reassures physicians on the safety and efficacy of the drugs which can lead to increased uptake of the product.
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Reduction in Time to Market
Real world evidence analytics can provide accurate data which can be validated so that pharma companies can secure reimbursement for the drug. Traditionally, pharma companies tend to play defensive and watch out for the consequence of a drug before rolling out in the market. But, accelerated approval process with real world evidence can bring the drugs to market much quicker resulting in revenue realization in advance.