Real-World Evidence for Regulatory Decisions: Concomitant Administration of Zoster Vaccine Live and Pneumococcal Polysaccharide Vaccine

Randomized clinical trials (RCTs) are no longer the sole source of data to inform guidelines, regulatory, and policy decisions. Real-world data (RWD), collected from registries, electronic health records, insurance claims, pharmacy records, social media, and sensor outputs from devices form real-world evidence (RWE), which can supplement evidence from RCTs. Benefits of using RWE include less time and cost to produce meaningful data; the ability to capture additional information, including social determinants of health that can impact health outcomes; detection of uncommon adverse events; and the potential to apply machine learning and artificial intelligence to the delivery of health care. Overall, combining data from RCTs and RWE would allow regulators to make ongoing and more evidence-based decisions in approving and monitoring products for diabetes.

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Immunogenicity and Safety of Concomitant Administration of 23-valent Pneumococcal Polysaccharide Vaccine and Trivalent Inactivated Influenza Vaccine in Adults Aged 50-70 Years

10.21203/rs.3.rs-99542/v1 ◽

2020 ◽

Author(s):

Yuanbao Liu ◽

Ran Hu ◽

Xiang Sun ◽

Min Zhang ◽

Fenyang Tang ◽

...

Keyword(s):

Adverse Events ◽

Influenza Vaccine ◽

Concomitant Administration ◽

Polysaccharide Vaccine ◽

Vaccine Group ◽

Combination Group ◽

Pneumococcal Polysaccharide Vaccine ◽

Clinical Safety ◽

Vaccination Rates ◽

Significant Difference

Abstract Background To explore the serological protective effect and to evaluate the safety after combined immunization with 23-valent pneumococcal polysaccharide vaccine and trivalent inactivated influenza vaccine in adults aged 50-70 years.Methods This trial was designed as a single-center, randomized, single-blind, and positive parallel control vaccination study. A total of 1,065 people aged 50-70 years old were observed in Zhenjiang city, Jiangsu Province. Three groups were established, namely, the combined vaccine group (366 people), the pneumonia vaccine group (363 people) and the influenza vaccine group (364 people). The subjects were randomly assigned to each group.Results A total of 1065 subjects were recruited. The noninferiority criterion of GMC ratios was met for all 7 pneumococcal serotypes after concomitant administration when compared with the administration of PPV23 alone. After concomitant administration, the noninferiority criterion of seroconversion rates was met for all inﬂuenza subtypes except the inﬂuenza H3 virus. The overall incidence of systemic adverse events was 6.67% (71/1065). The most frequently reported systemic adverse events were abnormal body temperature, muscle aches, nausea, and diarrhea. No statistically significant difference in systemic adverse events was found among the three groups.Conclusion The local and systemic response rates in the combination group, pneumonia group and influenza group were similar to those of many similar vaccines, suggesting that the vaccine has good clinical safety. Serological findings from the combination vaccine suggest that it should be encouraged in the future to increase vaccination rates for influenza and pneumonia.Trial Registration: ClinicalTrials.gov NCT02062281 February 13, 2014; Retrospectively registered.

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The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics

Journal of Diabetes Science and Technology ◽

10.1177/1932296819832661 ◽

2019 ◽

Vol 14 (2) ◽

pp. 345-349 ◽

Cited By ~ 7

Author(s):

David C. Klonoff

Keyword(s):

Real World ◽

Stakeholder Engagement ◽

Medical Community ◽

Real World Data ◽

The Public ◽

Public Meetings ◽

Real World Evidence ◽

Guidance Documents ◽

Approved Drugs ◽

Regulatory Decisions

FDA has launched a Real World Evidence (RWE) Program for using real-world evidence (RWE) to help support new indications for already approved drugs or biologics and postapproval studies. The plan also includes stakeholder engagement efforts, demonstration projects, leadership activities, and development of guidance documents to assist developers interested in using real-world data (RWD) to develop RWE to support FDA regulatory decisions. This plan was mandated by the Cures Act passed in 2016. Over the 24-month period from passage of the law until FDA officially announced their program, FDA has gone to considerable efforts to educate the public about the benefits of RWE and encourage researchers to consider situations where RWE trials can generate useful information. Through a variety of stakeholder engagement projects, including publication of articles in medical journals, participation in public meetings, and development of initiatives, FDA has put more effort into preparing the medical community for its new emphasis on RWE than any other new policy that I can recall.

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