Evidencia de vida real en oncología

Please download to get full document.

View again

All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
 3
 
  1. Reflexiones sobre la importancia de la evidencia del mundo real en medicina Mauricio Lema Medina Clínica de Oncología Astorga / Clínica SOMA, Medellín 2. Parte…
Share
Transcript
  • 1. Reflexiones sobre la importancia de la evidencia del mundo real en medicina Mauricio Lema Medina Clínica de Oncología Astorga / Clínica SOMA, Medellín
  • 2. Parte inicial – y original – de la conferencia impartida bajo los auspicios de Boehringer-Ingelheim
  • 3. Real-world evidence is derived from data about the uses and potential benefits and risks of a therapeutic agent outside a traditional clinical trial.
  • 4. Real-world evidence (RWE) captured in clinical practice provides information that complements the internally valid evidence on safety and efficacy generated by randomized controlled clinical trials
  • 5. Electronic Medical Records Billing databases Product registries Disease registries Personal devices Healh applications Sources of RWE Sherman, NEJM, 2016
  • 6. Generalize findings to larger, more inclusive populations of patients, that are not captured in the randomized-controlled trials (RCT) Why we need RWE? Sherman, NEJM, 2016
  • 7. RWE range Therapeutic development Outcomes research Patiente care Research on health care systems Quality improvement Safety surveillance Even, effectiveness studies “Real-world evidence can also provide information on how factors such as clinical setting and provider and health-system characteristics influence treatment effects and outcomes” Sherman, NEJM, 2016
  • 8. RWE perils Confluence of large data sets of uncertain quality and provenance Facile analytic tools tha can be used by nonexperts Shortage of experts • Incorrect or unreliable conclusions Sherman, NEJM, 2016
  • 9. “Traditional” clinical trials “Traditional” clinical trials are often conducted with specific populations and in specialized environments that differ from the realities of clinical or home settings. These trials may take measures designed to control variability and to ensure the quality of the data they generate, such as the development of long lists of eligibility criteria, the use of detailed case-report forms that exist separately from ordinary medical records, and the use of intensive monitoring and specialized research personnel to ensure adherence to a well- characterized protocol that defines study procedures and ensures precision in data collection. Sherman, NEJM, 2016
  • 10. “Traditional” clinical trials “Traditional” clinical trials are often conducted with specific populations and in specialized environments that differ from the realities of clinical or home settings. These trials may take measures designed to control variability and to ensure the quality of the data they generate, such as the development of long lists of eligibility criteria, the use of detailed case-report forms that exist separately from ordinary medical records, and the use of intensive monitoring and specialized research personnel to ensure adherence to a well- characterized protocol that defines study procedures and ensures precision in data collection. • Ensuring that treatment “works” Sherman, NEJM, 2016 • Uncertainty about generalizability. • Some interactions with illnesses and treatments, and issues adherence, that cannot be captured in RCTs
  • 11. Observational RWE Generalizability of technologies studied in RCTs Safety surveillance Examine changes in patterns of therapeutic use Measure the quality of the health care delivery • Hypothesis generating Sherman, NEJM, 2016
  • 12. Dr. Claas Frohn https://www.inoncology.com/real-world-evidence# STRENGHTS OF RANDOMIZED CONTROLLED TRIALS High internal validity owing to randomization, blinding, control/placebo Considered high-quality evidence Strict inclusion and exclusion criteria: Fewer patients required to identify a treatment effect
  • 13. Dr. Claas Frohn https://www.inoncology.com/real-world-evidence# LIMITATIONS OF RANDOMIZED CONTROLLED TRIALS Too selective: strict inclusion and exclusion criteria limit generalizability to broader patient populations Too short: duration of follow-up typically short, so difficult to detect long-term effects or outcomes Too small: sample size typically smaller than real-world evidence studies, so dificult to detect rare events
  • 14. Dr. Claas Frohn https://www.inoncology.com/real-world-evidence# STRENGHTS OF REAL-WORLD EVIDENCE STUDIES Study population reflects broader distribution of patients, perhaps more representative of routine care Potential to estimate real-world compliance and adherence A multitude of different comparators can be studied Potential for larger sample-sizes and longer follow-up
  • 15. Observational RWE Sherman, NEJM, 2016 But, RWE are very limited for the evaluation of treatment effects – due to confounding (particularly, if retrospective)
  • 16. Dr. Claas Frohn https://www.inoncology.com/real-world-evidence# LIMITATIONS OF REAL-WORLD EVIDENCE STUDIES Sophisticated designs and complex analyses ncessary to control for bias and confounding Data for key variables may be incomplete (e.g. Survival, BMI, smoking history, biomarkers, mutations…) Feasibility and sample size depends on real-world uptake of treatment in quiestion
  • 17. https://www.inoncology.com/real-world-evidence# The central role of RCT in clinical research is well established Real-world evidence complements data from clinical trials by demonstrating the effectiveness and safety profile of a treatment in routine everyday care
  • 18. Real experience with RWE Some “Tales from the Crypt”
  • 19. Once they get OUR data, we become garbage
  • 20. Data quality may be poor in some RWE Data was not queried in 2 or our RWE studies Data “needs” increase DURING the study In one RWE study, the number of variables changed during the excution phase. The sponsor expected all the re-process for free Some RWE “expect” treatments with very specific agents (but do not provide them) One leukemia study wanted a “specific” manufacturer, but didn’t provide it (in our health system it is impossible to gararantee a specific drug if options are available)
  • 21. https://www.inoncology.com/real-world-evidence# But, remember… Real-world evidence complements data from clinical trials by demonstrating the effectiveness and safety profile of a treatment in routine everyday care
  • 22. Conclusions RWE complent RCTs and they may particularly useful for: Generalizability (expansion of patients that may benefit) Detection of unusual safety signals Hypothesis generation Sherman, NEJM, 2016
  • Related Search
    Similar documents
    View more
    We Need Your Support
    Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

    Thanks to everyone for your continued support.

    No, Thanks
    SAVE OUR EARTH

    We need your sign to support Project to invent "SMART AND CONTROLLABLE REFLECTIVE BALLOONS" to cover the Sun and Save Our Earth.

    More details...

    Sign Now!

    We are very appreciated for your Prompt Action!

    x