Trial data available in the FDA and EMA Reports: A Cross-Sectional - - PowerPoint PPT Presentation

▶
trial data available in the fda and ema reports a cross
SMART_READER_LITE
LIVE PREVIEW

Trial data available in the FDA and EMA Reports: A Cross-Sectional - - PowerPoint PPT Presentation

Apr 19, 2023 10 likes •135 views

Trial data available in the FDA and EMA Reports: A Cross-Sectional Study Jeppe Bennekou Schroll a , MD, The Nordic Cochrane Centre Maher Abdel-Sattar b , PharmD, University of California Lisa Bero b , PhD, University of California Background

slide-1
SLIDE 1

Trial data available in the FDA and EMA Reports: A Cross-Sectional Study

Jeppe Bennekou Schrolla, MD, The Nordic Cochrane Centre Maher Abdel-Sattarb, PharmD, University of California Lisa Berob, PhD, University of California

slide-2
SLIDE 2

Background

 Regulatory data can alter meta-analysis (Hart2012)  Regulatory data is only obtained in 3% of the Cochrane

reviews that obtained unpublished data (Schroll2013)

 Lack of guidance on what agency to search  Recent changes by drug agencies could make previous

research outdated

Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses

  • f drug trials: reanalysis of meta-analyses. BMJ 2012;344:d7202.

Schroll JB, Bero L, Gøtzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ 2013;346:f2231.

slide-3
SLIDE 3

Background

 United states:

 Drug Approval Package  Medical Review  Statistical Review  etc

 Europe:

 Assesment report 

European Public Assesment Report(EPAR)

slide-4
SLIDE 4

Purpose

To compare the accessibility, comprehensiveness and usefulness of data available from the European Medicines Agency (EMA) and Food and Drug Administration (FDA) drug reports.

slide-5
SLIDE 5

Methods

 EMA and FDA websites searched for all new molecular

entities that were approved by both agencies

 Data extraction from reports by two researchers

 Accessibility  Comprehensiveness  Usefulness for metanalysis (benefit and harms)

 Assessment of each agency  Descriptive analysis

slide-6
SLIDE 6
slide-7
SLIDE 7

Characteristics of documents

FDA EMA

Average number of pages1 (SD) 267 (158) 87 (27) Table of contents and searchable % (n) 70% (19) 100% (27) File partially redacted % (n) 100% (27) 0% (0)3 Reasons for redaction indicated % (n) 96% (26) 100% (27) Lay summaries provided 0% 100% Communication between regulator and applicant 100% 0% Full trial reports /protocols available 0% 0%

slide-8
SLIDE 8

Characteristics of trials and efficacy data

FDA % (n) EMA % (n) Overview of trials with trial ID /trial name and summary 100% (27) 100% (27) ClinicalTrials.gov ID or corresponding 0% (0) 0% (0) Names of trial investigators and conflict of interest 0% (0) 0% (0) Trial methodology assessed (risk of bias domains) 19% (5) 0% (0) Patient population specified (inclusion, exclusion criteria) 96% (26) 96% (26) Intervention and comparison group specified 89% (24) 93% (25) Can the results be used in a meta-analysis? 100% (27) 96% (26 )

slide-9
SLIDE 9

Harms

FDA EMA Table of common adverse events 96% (26) 67% (18) All important harms reported 93% (25) 26% (7) Numerical results provided – safety 100% (27) 100% (27) Risk management plan / pharmacovigilance 48% (13) 100% (27)

  • further trials / studies required

78% (21) 48% (13)*

  • follow up existing trials

22% (6) 22% (6)

  • labeling restriction

4% (1) 100% (27) REMS / Educational material 30% (8) 26% (7)

slide-10
SLIDE 10

Discussion

 Harms and efficacy data are available at the drug agencies  Lack of accesibility and guidance can be the reason why

data is rarely used

 The trials cannot easily be linked to publications  Redaction of non-approved indications  Only agency to sponsor communications available

slide-11
SLIDE 11

Conclusion

 Both agencies provided data sufficient for meta-analysis  FDA provided more data on harms  EMA was more accessible and provided data on

withdrawn or rejected drugs

 We recommend searching both agencies

slide-12
SLIDE 12

Questions