The Added Value of Real-World Evidence to Connect Disconnected Networks for Network Meta-Analysis: A Case Study in Rheumatoid Arthritis

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.

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SMART for the treatment of asthma: a network meta-analysis of real-world evidence

Respiratory Medicine ◽

10.1016/j.rmed.2021.106611 ◽

2021 ◽

pp. 106611

Author(s):

Paola Rogliani ◽

Richard Beasley ◽

Mario Cazzola ◽

Luigino Calzetta

Keyword(s):

Real World ◽

Meta Analysis ◽

Real World Evidence

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Added value of combining methotrexate with a biological agent compared to biological monotherapy in rheumatoid arthritis patients: A systematic review and meta-analysis of randomised trials

Seminars in Arthritis and Rheumatism ◽

10.1016/j.semarthrit.2018.10.002 ◽

2019 ◽

Vol 48 (6) ◽

pp. 958-966 ◽

Cited By ~ 1

Author(s):

Simon Tarp ◽

Tanja S. Jørgensen ◽

Daniel E. Furst ◽

Anna Dossing ◽

Peter C. Taylor ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Systematic Review ◽

Meta Analysis ◽

Biological Agent ◽

Added Value ◽

Randomised Trials

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Development of an Innovative Real-World Evidence Registry for the Herpes Simplex Virus: Case Study

JMIR Dermatology ◽

10.2196/16933 ◽

2020 ◽

Vol 3 (1) ◽

pp. e16933 ◽

Cited By ~ 2

Author(s):

Michelle Helena van Velthoven ◽

Ching Lam ◽

Caroline de Cock ◽

Terese Stenfors ◽

Hassan Chaudhury ◽

...

Keyword(s):

Herpes Simplex Virus ◽

Herpes Simplex ◽

Real World ◽

Physical Symptoms ◽

Use Cases ◽

Real World Data ◽

World Data ◽

Real World Evidence ◽

Simplex Virus

Background Infection with the herpes simplex virus (HSV) is common but not well understood. Furthermore, there remains a social stigma surrounding HSV that can have psychosocial implications for those infected. Despite many patients infected with HSV experiencing mild-to-severe physical symptoms, only one subeffective treatment is available. A registry collecting real-world data reported by individuals potentially infected with HSV could help patients to better understand and manage their condition. Objective This study aimed to report on the development of a registry to collect real-world data reported by people who might be infected with HSV. Methods A case study design was selected as it provides a systematic and in-depth approach to investigating the planning phase of the registry. The case study followed seven stages: plan, design, prepare, collect, analyze, create, and share. We carried out semistructured interviews with experts, which were thematically analyzed and used to build use cases for the proposed registry. These use cases will be used to generate detailed models of how a real-world evidence registry might be perceived and used by different users. Results The following key themes were identified in the interviews: (1) stigma and anonymity, (2) selection bias, (3) understanding treatment and outcome gaps, (4) lifestyle factors, (5) individualized versus population-level data, and (6) severe complications of HSV. We developed use cases for different types of users of the registry, including individuals with HSV, members of the public, researchers, and clinicians. Conclusions This case study revealed key considerations and insights for the development of an appropriate registry to collect real-world data reported by people who might be infected with HSV. Further development and testing of the registry with different users is required. The registry must also be evaluated for the feasibility and effectiveness of collecting data to support symptom management. This registry has the potential to contribute to the development of vaccines and treatments and provide insights into the impact of HSV on other conditions.

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