Test your knowledge

Question 1 of 4

Please choose the most correct answer Information Icon Nurse

What challenges are involved in determining causality between a reported AE and a drug in the real world?

  • Letter A Icon

    AE rates for a drug are not compared against a control group (eg, placebo) in the real-world setting

  • Letter B Icon

    Data regarding AEs reported in the real world may be incomplete

  • Letter C Icon

    There may be unidentified or unaccounted for confounding factors

  • Letter D Icon

    All of the above

Which of the below statements is true:

  • Letter A Icon

    All real-world AEs reported to a sponsor pharmaceutical company must be reported to regulatory agencies (eg, the FDA), regardless of causality

  • Letter B Icon

    Real-world AEs reported to a sponsor pharmaceutical company only need to be reported to regulatory agencies (eg, the FDA) if there is a suspected causal relationship between the drug and the AE

Who decides whether a product label update is required based on AEs reported post-drug approval?

  • Letter A Icon

    Regulatory agency (eg, the FDA)

  • Letter B Icon

    Sponsor pharmaceutical company

  • Letter C Icon

    All of the above

Did you find the information presented to be helpful in understanding post-marketing safety surveillance?

  • Letter A Icon

    YES

  • Letter B Icon

    NO

You received the following score:

0 3

You indicated this content was:

Not Helpful

What topic was the most informative?

  • Letter A Icon

    Characteristics of clinical trial AEs

  • Letter B Icon

    Characteristics of real-world AEs

  • Letter C Icon

    AE reporting

  • Letter D Icon

    Safety signal detection and evaluation

  • Letter E Icon

    Safety signal communication to the healthcare community

Doctor

References

1. Beninger P. Clin Ther. 2018;40:1991-2004. 2. Singh S, Loke YK. Trials. 2012;13:138. 3. WHO. Safety of Medicines. A guide to detecting and reporting adverse drug reactions. 2002. 4. Ioannidis JPA, et al. Ann Intern Med. 2004;141:781-788. 5. Lineberry N, et al. BMJ. 2016;355:i5078. 6. Berlin JA, et al. Am J Public Health. 2008;98:1366-1371. 7. FDA. Guidance for Clinical Trial Sponsors. Establishment and Operation of Clinical Trial Data Monitoring Committees. 2006. 8. FDA. Guidance for Industry. Safety Labeling Changes. 2013. 9. Kumar A. Am J Health-Syst Pharm. 2017;74:606-612. 10. FDA. Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. 2005. 11. FDA. Questions and Answers on FDA's Adverse Event Reporting System (FAERS). https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers. Accessed October 14, 2019. 12. FDA. Guidance for Industry. Providing Submissions in Electronic Format. Postmarketing Safety Reports. 2014. 13. WHO. Open Access to the WHO Global Pharmacovigilance Database. https://www.who.int/medicines/news/glob_pharmvig_database_qa/en/. Accessed October 14, 2019. 14. EMA. Guideline on good pharmacovigilance practices (GVP). 2017. 15. Koutkias VG, Jaulent MC. Drug Saf. 2015;38:219-232. 16. EMA. Guide on the interpretation of spontaneous case reports of suspected adverse reactions to medicines. 2017. 17. Council for International Organizations of Medical Sciences Working Group IV. Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals. 1998. 18. FDA. Guidance for Industry. Development of a Shared System REMS. 2018. 19. FDA. Guidance for Industry and Investigators. Safety Reporting Requirements for INDs and BA/BE Studies. 2012. 20. FDA. Guidance. Classifying Significant Postmarketing Drug Safety Issues. 2012.

That is not quite right

CROSS

The correct answer is: D (All of the above)

  • In randomized controlled trials, incidence of AEs for a product is compared with a control (eg, placebo); patients do not receive placebo in the real world4-6
  • Establishing whether a causal relationship exists between real-world AEs and the drug is challenging because:
    • There may be unidentified or unaccounted for confounding factors10
    • The incidence of real-world AEs includes background rates of the affected population10
  • Data spontaneously reported to sponsor company may be incomplete or confounded10,14

That is not quite right

CROSS

The correct answer is: D (All of the above)

  • In randomized controlled trials, incidence of AEs for a product is compared with a control (eg, placebo); patients do not receive placebo in the real world4-6
  • Establishing whether a causal relationship exists between real-world AEs and the drug is challenging because:
    • There may be unidentified or unaccounted for confounding factors10
    • The incidence of real-world AEs includes background rates of the affected population10
  • Data spontaneously reported to sponsor company may be incomplete or confounded10,14

That is not quite right

CROSS

The correct answer is: D (All of the above)

  • In randomized controlled trials, incidence of AEs for a product is compared with a control (eg, placebo); patients do not receive placebo in the real world4-6
  • Establishing whether a causal relationship exists between real-world AEs and the drug is challenging because:
    • There may be unidentified or unaccounted for confounding factors10
    • The incidence of real-world AEs includes background rates of the affected population10
  • Data spontaneously reported to sponsor company may be incomplete or confounded10,14

That is correct!

Correct Tick
  • In randomized controlled trials, incidence of AEs for a product is compared with a control (eg, placebo); patients do not receive placebo in the real world4-6
  • Establishing whether a causal relationship exists between real-world AEs and the drug is challenging because:
    • There may be unidentified or unaccounted for confounding factors10
    • The incidence of real-world AEs includes background rates of the affected population10
  • Data spontaneously reported to sponsor company may be incomplete or confounded10,14

That is correct!

Correct Tick
  • In the post-marketing setting, the manufacturer must communicate all AEs that are reported to them to regulatory agencies regardless of causality11

That is not quite right

CROSS

The correct answer is: A

  • In the post-marketing setting, the manufacturer must communicate all AEs that are reported to them to regulatory agencies regardless of causality11

That is correct!

Correct Tick
  • Regulatory agencies have the final decision on the content and language included in the product label and what subsequent action may be required if signals are identified post-approval8,9,17,19,20

That is not quite right

CROSS

The correct answer is: A (Regulatory agency [eg, the FDA])

  • Regulatory agencies have the final decision on the content and language included in the product label and what subsequent action may be required if signals are identified post-approval8,9,17,19,20

That is not quite right

CROSS

The correct answer is: A (Regulatory agency [eg, the FDA])

  • Regulatory agencies have the final decision on the content and language included in the product label and what subsequent action may be required if signals are identified post-approval8,9,17,19,20