We Medialis Ltd are pleased to share with you the third of a series of updates on the principles underlying our work, the four pillars of our medical #thirty22 #realworldevidence strategy.
Pillar 3 of our strategy focuses on the application of the #multiplestakeholderapproach to #realworldevidence generation for #clinicalstudies. Our research showed that stakeholder groups have distinct evidence needs with which #pharma is currently misaligned
link : https://lnkd.in/e7Cdd4jw.
Our innovative multiple-stakeholder approach allows us to design and generate real-world evidence targeted to meet specific stakeholder needs, giving your medicine the best chance of a successful adoption with a minimum number of stakeholder engagements.
Among other projects, our current #corporatesocialresponsibility programme has applied the multiple-stakeholder approach to generate high-quality #patientregistries (PAC-19QoLREG in long #COVID19) with greater utility to stakeholders than existing registries due to their inclusion of relevant indicators.
Contact Medialis Ltd to find out how the multiple-stakeholder approach can enhance real-world evidence generation and regulatory/payor submissions in your #patientgroup and new #medicine.
#clinicaltrials #pharmaceuticalindustry #pharmaceuticals #medicalaffairs #clinicalresearch #rwe #orphandrugs #raredisease #neutraltheory #jandhyalamethod #thirty22RWEstrategy #medicineadoptionmodel
Introduction
Those invested in the outcome of specific decisions may seek to inform the decision-maker by generating relevant evidence. With multiple decision-makers, the evidence generator benefits from understanding whether their needs differ. This was explored using relevant stakeholders’ preferences on quality indicators (QIs) of rare disease patient registries (RDRs), a common vehicle for generating evidence, to support the adoption of new medicines.
Methods
The Jandhyala method was used to compare the observed consensus on RDR quality indicators from each stakeholder group (SHG) and between the combined pharmaceutical (pharma) and non-pharmaceutical (non-pharma) SHG population.
Results
All non-pharmaceutical stakeholder groups were equally unique – suggesting QIs peculiar to themselves – Patients (13/102; 12.75%); Payors (5/102; 4.90%); Prescribers (7/102; 6.86%) to the same degree. Non-pharmaceutical stakeholders generated 31/102 (30.39%) unique QIs. Pharma stakeholder generated 25/102 (24.51%). This totals 56/102 (54.90%) QIs without a match. Two QIs were unanimously suggested and agreed upon by all SHGs (7/7; 100%) – “Engages with patients and gains their buy-in” and “Includes a core data set as part of outcomes”. There was homogenous consensus on common QIs between: Commercial – Market Access (13/52; 25%; p = .005) SHGs; Commercial – Medical Affairs (9/47; 19.15%; p = .001) SHGs; Commercial – Payor (11/41; 21.15%; p = .012) SHGs, and Market Access – Regulatory Affairs (10/41; 19.61%; p = .008) SHGs.
Conclusions
A multiple stakeholder approach for generating real-world evidence can be justified. The potential mismatch of 54.9% between pharma and non-pharma stakeholders indicates a critical misalignment between generator and consumer of its RWE. Pharmaceutical SHG’s were highlighted for greater alignment with Patients and Payor (non-pharma) groups.