Evidence map›Paper›PMID 35610469›Full record

ReviewTherapeutic innovation & regulatory science2022

Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Jenn W Sellers, Camelia M Mihaescu, Kassa Ayalew, Phillip D Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A Khin

Erratum issuedOpen access · hybridAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Therapeutic innovation & regulatory science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Lessons and Insights from a Case Study on Clinical Trial Fraud.Therapeutic innovation & regulatory science · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Jenn W SellersDivision of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA. jenn.sellers@fda.hhs.gov.
Camelia M MihaescuInspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
Kassa AyalewDivision of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.
Phillip D KronsteinDivision of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.
Bei YuDivision of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.
Yang-Min NingDivision of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.
Miguel RodriguezInspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
LaKisha WilliamsDivision of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.
Ni A KhinDivision of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.
Center for Drug Evaluation and Research · USEuropean Medicines Agency · NLUnited States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported.

methodsWe identified common inspections of clinical investigators, sponsors, and contract research organizations conducted by both agencies in support of marketing applications that had the same trial data submitted between 2009 and 2015. We grouped inspection findings into deficiency areas. We reviewed and compared these findings and calculated concordance rate for each deficiency area.

resultsTwenty-six clinical investigator sites and 23 sponsors/contract research organizations were inspected by both agencies in support of 31 marketing applications during this period. For FDA, the most common GCP findings were deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management issues for sponsor/contract research organization inspections. For EMA, deficiencies related to Documentation (including Trial Master File) were the most common findings for both clinical investigator and sponsor/contract research organization inspections. There was high concordance, of approximately 90%, for deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management for sponsor/contract research organization inspections between the two agencies. There was a concordance rate of about 70% for Documentation deficiencies for both clinical investigator and sponsor/contract research organization GCP inspections.

conclusionGCP inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued FDA-EMA GCP collaboration.

Indexed as

Guideline AdherenceResearch PersonnelDocumentationHumansMarketingUnited StatesUnited States Food and Drug AdministrationBioresearch monitoringClinical investigatorGood clinical practice inspectionInspection findingSponsor

Identifiers

PMID35610469
PMCPMC9356921
OpenAlexW4281389780

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.