For When You Need Sources Instead of Solutions

Sometimes you don’t need solutions, instead you need access to data sources that might provide you with solutions…we completely understand and are happy to help…

Evidence generated by high-quality observational research is fundamental to understanding the safety and effectiveness of medicines in everyday use by patients and doctors.

[EMA – Global Regulatory Workshop on COVID-19 Real-World Evidence and Observational Studies, July 2020]

RWE obtained from high-quality methodology can enhance the ability to make informed regulatory decisions. Health Canada will consider the use of RWE to support regulatory decision making regarding the benefits and risks of prescription drug products.

[Health Canada – Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle, March 2019]

Ethical Standards for Real-World Research

GXPs for NIS and Observational Studies

GXPs for NIS and Observational Studies

  • GVPs – Good Pharmacovigilance Practices (EU)
  • GPP – Guidelines for Good Pharmacoepidemiology Practices (Global)
  • GEP – CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 (Global)
GXPs for NIS and Observational Studies

Methodological Standards for NIS and Observational Studies

Observational Study Reporting Guidelines and Checklists (STROBE)

Secondary Use of Health Data

Digital Health Hubs

Data Integrity Guidance

Medical Devices

Mobile Medical Applications (MMA)

Use of Real-World Evidence in Health Technology Assessments

  • EU: EUnetHTA – Registry Evaluation and Quality Standards Tool (REQueST®)
    • REQueST® is designed to be used by i) evidence developers to assess the quality of their registry, and ii) international organisations considering whether to use registry data for HTA and regulatory purposes. The purpose is to highlight areas of a registry that need improvement in order to maximise the quality of its data and ensure that those data can be used for HTA and regulatory purposes
  • Global Review: Canadian Agency for Drugs and Technologies in Health – Use of Real-World Evidence in Single-Drug Assessments Environmental Scan, April 2018

    • The evidence hierarchies which are used by regulatory and HTA agencies place RWE at a lower level of quality or value than RCTs. Thus, RWE is used to confirm or supplement, rather than replace, the evidence from RCTs on the safety and efficacy of drugs. There was recognition of specific situations where RWE may be of particular value, such as: when RCTs are not feasible (very rare conditions) or are unethical (pregnancy), there is significant unmet need or in life-threatening conditions, and to identify serious, rare or long-term adverse effects. HTA agencies stated that the sole use of RWE to determine the comparative effects of a drug requires a prudent approach and any conclusions based on RWE alone would be more circumspect