Dr. Chitra Lele, Sciformix Corporation
Challenges in bringing a drug to market and its life-cycle maintenance continue well after regulatory approval. While there is greater awareness about the benefits and risks of the product among healthcare professionals, consumers and payers, the patient perspective is becoming more important to the payers. There is growing realisation
of the need for a patient-centered healthcare system.
All interested parties are demanding more evidence beyond just safety and efficacy data from clinical trials, with effectiveness of treatments and comparative effectiveness, relative to other therapies, being important aspects to measure. This requires real-world data, namely patient reported outcome (PRO) data, that are based on longer follow-up and a more representative sample of the patient population than is typically used in studies.
These data are sourced from claims databases, disease registries and electronic health records (EHRs), but the quality may be poor due to inadequate validation and even missing data. Therefore, more outcomes data have to be generated in a planned manner to provide comprehensive evidence of the drug’s value.