OBJECTIVES: To understand the need for adoption of patient centric evidence generation management best practice

METHODS: Industry Observation

RESULTS: Life-sciences industry is adopting patient-centricity across drug development for generating clinical trial and real-world evidence. Industry has to demonstrate tangible utility of evidence with respect to value and role of each evidence aligned to patient centricity, like reducing regulatory and reimbursement cycles for improved access. This improved patient access includes tangible outcomes of cycle time for drug reaching the patients, accessible & affordable of treatments (Covid Pandemic diagnosis, prevention & treatment) and save patient lives. Medical Affairs in collaboration with other functions needs to play a pivotal role.

• Informal mechanisms for evidence grading. The grading needs to be linked to utility, role and contribution in decision scenarios across the product life cycle.
• Significant variation in the adoption, impact calculation and governance of the evidence.
• Significant variation in designing and applying comprehensive definitions of the evidence metrics.

CONCLUSIONS: Following best practices can be adopted for demonstrating tangible role of evidence generation management linked with patient centricity.

• Collaborative development of a comprehensive framework demonstrating tangible role & utility of all the evidence generated across the life cycle and linkage with patient centric outcomes.
• The investment for evidence generation management activities across life needs to be linked with patient centricity objectives
• The framework needs to be adopted for all the evidence generated for each product across the product life cycle.
• The framework should involve a tangible scoring for each evidence by evaluating the value and impact of evidence
• Additionally, weightages with respect to scientific strength of the evidence, needs to be applied as per NCCN evidence scoring guidelines (Oncology) , ISPOR, STROBE, PCORI, ENCePP, GRACE and others for Real World Evidence.