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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]

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

• EU: ENCePP Guide on Methodological Standards in Pharmacoepidemiology
• Global: Guidelines for Good Pharmacoepidemiology Practices of the International Society of Pharmacoepidemiology (ISPE GPP)

• Canada: Health Canada – Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle, March 2019
• China: CDA – Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019
• EU: EMA PASS Protocol Format and Content Guidance
• EU: ENCePP Checklist for Study Protocols
• Global: Guidelines for Good Pharmacoepidemiology Practices of the International Society of Pharmacoepidemiology (ISPE GPP)

• Canada: Health Canada – Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle, March 2019
• China: CDA – Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019
• EU: EMA PASS Protocol Format and Content Guidance
• EU: ENCePP Checklist for Study Protocols
• Global: Guidelines for Good Pharmacoepidemiology Practices of the International Society of Pharmacoepidemiology (ISPE GPP)

• STROBE Observational Study Report Checklists (2007)
• STROBE checklist for cohort, case-control, and cross-sectional studies (combined) 
- download PDF/ Word
• Checklist for cohort studies 
- download PDF/ Word
• Checklist for case-control studies – 
download PDF/ Word
• Checklist for cross-sectional studies 
- download PDF/ Word
• Draft STROBE checklist for conference abstracts – 
download PDF
• STROBE Initiative.  Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ,Poole C, Schlesselman JJ, Egger M; Epidemiology. 2007 Nov;18(6):805-35. PMID: 18049195

• EU: European Health Data & Evidence Network (EHDEN)
  • Launched to address the current challenges in generating insights and evidence from real-world clinical data at scale, to support patients, clinicians, payers, regulators, governments, and the pharmaceutical industry in understanding wellbeing, disease, treatments, outcomes and new therapeutics and devices
• Finland: Website – Secondary Use of Health and Social Data
  • Finland:Act 552/2019: Act on the Secondary Use of Health and Social Data
• USA: Healthdata.gov
  • Site is dedicated to making data discoverable and making valuable government data available to the public in the hopes of better health outcomes for all

• EU: EMA experience with the review of digital technology proposals in medicine development programmes – 3rd Industry Stakeholder Platform on R&D support, 18 May 2018
• Global: WHO Guideline: Recommendations on Digital Interventions for Health System Strengthening, 2019
• USA: FDA – Digital Health
• USA: FDA – Digital Health Innovation Action Plan

• France: Health Data Hub
• UK: Health Data Research UK
• USA: FDAs Digital Health Centre of Excellence

• EU: EMA – Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, Nov 2018
• EU: EMA – Draft Guideline on Registry-Based Studies, Sept 2020
• EU: EUNetHTA – Registry Evaluation and Quality Standards Tool (REQueST®)
• EU: European Platform on Rare Disease Registration
• Global: CTTI Recommendations – Use of Real-World Data to Plan Eligibility Criteria and Enhance Recruitment, Oct 2019
• Global: CTTI Recommendations – Registry Trials, Oct 2019

• Global: WHO – Guideline in Data Integrity – Draft For Comments, Oct 2019
• USA: FDA – Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry, Dec 2018
• UK: MHRA – Guidance on GxP data integrity, March 2018

• EU: Medical Device Regulation (Regulation EU/2017/745)
  • The MDR has a transition period of three years and will fully apply from 26 May 2020
• EU: In Vitro Medical Device Regulation (Regulation EU/2017/746)
  • The IVDR has a transition period of five years and will fully apply from 26 May 2022
• EMA Website – Medical Devices

• Global: IMDRF – International Medical Device Regulators Forum
• USA: FDA – Software as a Medical device (SaMD)
• USA: FDA – Global Approach to Software as a Medical Device
• USA: FDA – Policy for Device Software Functions and Mobile Medical Applications
• USA: FDA – Device Software Functions Including Mobile Medical Applications
• USA: FDA – Examples of Device Software Functions the FDA Regulates
• USA: FDA – Examples of Mobile Apps That Are NOT Medical Devices
• USA: FDA – Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

• USA: FDA – What are Mobile Medical Apps?
• USA: FDA – How Does the FDA Regulate Device Software Functions?
• USA: FDA – Device software functions that are the focus of FDA oversight
• USA: FDA – Software functions for which the FDA intends to exercise enforcement discretion
• USA: FDA – Examples of Premarket Submissions that Include MMAs Cleared or Approved by the FDA

• 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